Document text
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
BNT162b1 18-55 10 μg C4591001 1001
10011004 42 Female 165 58.6 21.5 White Non-Hispanic/non -
Latino 01MAY2020
C4591001 1001
10011006 28 Male 175 75.3 24.6 White Non-Hispanic/non -
Latino 04MAY2020
C4591001 1001
10011007 24 Male 187 83.8 24 Black or African
American Non-Hispanic/non -
Latino 04MAY2020
C4591001 1001
10011008 27 Male 180 71.8 22.2 White Non-Hispanic/non -
Latino 04MAY2020
C4591001 1001
10011009 40 Male 175 77.8 25.4 Asian Non-Hispanic/non -
Latino 04MAY2020
C4591001 1002
10021003 26 Male 170.94 76.36 26.1 White Non-Hispanic/non -
Latino 29APR2020
C4591001 1002
10021004 28 Female 160.02 70.45 27.5 White Non-Hispanic/non -
Latino 29APR2020
C4591001 1002
10021007 26 Male 182.88 67.27 20.1 White Non-Hispanic/non -
Latino 30APR2020
C4591001 1002
10021009 25 Female 162.56 57.95 21.9 Asian Non-Hispanic/non -
Latino 30APR2020
C4591001 1002
10021011 37 Male 166.37 62.73 22.6 White Hispanic/Latino 30APR2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 1
FDA-CBER-2021-5683-0029232
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1002
10021012 25 Female 165.1 78.18 28.6 White Non-Hispanic/non -
Latino 30APR2020
C4591001 1002
10021013 25 Female 162.56 57.73 21.8 Asian Non-Hispanic/non -
Latino 01MAY2020
20 μg C4591001 1001
10011067 42 Female 165 72.5 26.6 Black or African
American Non-Hispanic/non -
Latino 23JUN2020
C4591001 1001
10011068 51 Male 176 62.6 20.2 White Non-Hispanic/non -
Latino 23JUN2020
C4591001 1001
10011070 51 Male 176.5 87.2 28 White Non-Hispanic/non -
Latino 23JUN2020
C4591001 1001
10011071 32 Male 169.5 72.8 25.3 White Non-Hispanic/non -
Latino 24JUN2020
C4591001 1001
10011076 30 Male 180.03 80.7 24.9 White Non-Hispanic/non -
Latino 25JUN2020
C4591001 1002
10021079 43 Female 175.26 76.82 25 White Non-Hispanic/non -
Latino 22JUN2020
C4591001 1002
10021080 51 Male 177.8 69.55 22 White Non-Hispanic/non -
Latino 22JUN2020
C4591001 1002
10021081 34 Male 177.8 90.91 28.7 White Non-Hispanic/non -
Latino 22JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 2
FDA-CBER-2021-5683-0029233
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1002
10021082 54 Female 162.56 67.27 25.4 White Non-Hispanic/non -
Latino 22JUN2020
C4591001 1002
10021084 49 Male 177.8 90.45 28.6 White Non-Hispanic/non -
Latino 23JUN2020
C4591001 1002
10021085 49 Male 180.34 94.32 28.9 White Non-Hispanic/non -
Latino 23JUN2020
C4591001 1002
10021087 51 Male 176.53 84.77 27.1 White Non-Hispanic/non -
Latino 25JUN2020
30 μg C4591001 1001
10011011 32 Female 155 57.2 23.8 White Hispanic/Latino 05MAY2020
C4591001 1001
10011012 50 Male 184 85 25.1 Asian Non-Hispanic/non -
Latino 05MAY2020
C4591001 1001
10011015 28 Male 190.5 91.2 25.1 White Non-Hispanic/non -
Latino 06MAY2020
C4591001 1001
10011017 52 Male 188 91.1 25.8 White Non-Hispanic/non -
Latino 07MAY2020
C4591001 1001
10011019 27 Male 175.3 83.2 27.1 White Not reported 07MAY2020
C4591001 1001
10011020 26 Male 170.18 74.8 25.8 White Non-Hispanic/non -
Latino 07MAY2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 3
FDA-CBER-2021-5683-0029234
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1001
10011024 23 Male 170 74.6 25.8 Asian Non-Hispanic/non -
Latino 11MAY2020
C4591001 1002
10021006 41 Female 157.48 59.09 23.8 White Non-Hispanic/non -
Latino 30APR2020
C4591001 1002
10021014 38 Female 158.75 58.18 23 White Non-Hispanic/non -
Latino 01MAY2020
C4591001 1002
10021015 48 Female 166.37 66.14 23.8 White Non-Hispanic/non -
Latino 01MAY2020
C4591001 1002
10021017 35 Female 158.75 55.91 22.1 White Non-Hispanic/non -
Latino 01MAY2020
C4591001 1002
10021020 30 Female 179.07 74.55 23.2 White Non-Hispanic/non -
Latino 01MAY2020
Placebo 18-55 Placebo C4591001 1001
10011005 41 Female 168 50.3 17.8 White Non-Hispanic/non -
Latino 04MAY2020
C4591001 1001
10011066 25 Male 185 78.3 22.9 White Non-Hispanic/non -
Latino 22JUN2020
C4591001 1001
10011069 37 Female 171.5 72.7 24.7 White Non-Hispanic/non -
Latino 23JUN2020
C4591001 1002
10021005 54 Male 170.18 64.09 22.1 White Non-Hispanic/non -
Latino 29APR2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 4
FDA-CBER-2021-5683-0029235
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1002
10021008 32 Male 177.17 78.18 24.9 Asian Non-Hispanic/non -
Latino 30APR2020
C4591001 1002
10021018 51 Female 175.26 71.82 23.3 White Non-Hispanic/non -
Latino 01MAY2020
C4591001 1002
10021021 44 Male 172.72 81.36 27.2 White Non-Hispanic/non -
Latino 04MAY2020
C4591001 1002
10021022 33 Male 163.83 63.41 23.6 White Non-Hispanic/non -
Latino 04MAY2020
C4591001 1002
10021083 22 Male 173.99 83.64 27.6 White Non-Hispanic/non -
Latino 22JUN2020
BNT162b1 65-85 10 μg C4591001 1001
10011037 66 Female 159 66.4 26.3 White Non-Hispanic/non -
Latino 01JUN2020
C4591001 1001
10011039 69 Male 179 87.9 27.4 White Non-Hispanic/non -
Latino 03JUN2020
C4591001 1001
10011040 65 Male 161.5 67.5 25.9 White Non-Hispanic/non -
Latino 04JUN2020
C4591001 1001
10011041 70 Female 172.2 64.6 21.8 White Non-Hispanic/non -
Latino 04JUN2020
C4591001 1001
10011044 79 Male 167.64 68.4 24.3 White Non-Hispanic/non -
Latino 04JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 5
FDA-CBER-2021-5683-0029236
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1001
10011045 69 Female 162 60.1 22.9 White Non-Hispanic/non -
Latino 05JUN2020
C4591001 1002
10021043 67 Male 177.8 92.27 29.1 White Non-Hispanic/non -
Latino 29MAY2020
C4591001 1002
10021044 68 Female 166.37 47.05 17 White Non-Hispanic/non -
Latino 29MAY2020
C4591001 1002
10021045 66 Female 160.02 71.36 27.8 White Non-Hispanic/non -
Latino 29MAY2020
C4591001 1002
10021049 82 Female 160.02 61.36 23.9 White Non-Hispanic/non -
Latino 01JUN2020
C4591001 1002
10021052 65 Female 163.83 69.55 25.9 White Non-Hispanic/non -
Latino 03JUN2020
C4591001 1002
10021053 70 Female 151.13 65.68 28.7 White Non-Hispanic/non -
Latino 03JUN2020
20 μg C4591001 1001
10011043 74 Female 166 61.3 22.2 White Non-Hispanic/non -
Latino 04JUN2020
C4591001 1001
10011049 68 Female 170.2 66 22.8 White Non-Hispanic/non -
Latino 08JUN2020
C4591001 1001
10011050 78 Male 178 93.8 29.6 White Non-Hispanic/non -
Latino 10JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 6
FDA-CBER-2021-5683-0029237
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1001
10011052 65 Female 166 65 23.6 White Non-Hispanic/non -
Latino 10JUN2020
C4591001 1001
10011055 67 Female 162 65.7 25 Black or African
American Non-Hispanic/non -
Latino 12JUN2020
C4591001 1001
10011059 72 Female 160 62 24.2 White Non-Hispanic/non -
Latino 15JUN2020
C4591001 1002
10021054 66 Female 175.26 73.41 23.8 White Non-Hispanic/non -
Latino 03JUN2020
C4591001 1002
10021060 81 Male 172.72 72.27 24.2 White Non-Hispanic/non -
Latino 04JUN2020
C4591001 1002
10021064 68 Male 167.64 78.18 27.8 White Non-Hispanic/non -
Latino 05JUN2020
C4591001 1002
10021067 70 Male 172.72 76.82 25.7 White Non-Hispanic/non -
Latino 10JUN2020
C4591001 1002
10021068 67 Female 172.72 77.27 25.8 White Non-Hispanic/non -
Latino 10JUN2020
C4591001 1002
10021071 71 Female 167.64 63.64 22.6 White Non-Hispanic/non -
Latino 11JUN2020
30 μg C4591001 1001
10011046 65 Male 178 82.2 25.9 White Non-Hispanic/non -
Latino 05JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 7
FDA-CBER-2021-5683-0029238
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1001
10011048 66 Female 165.5 55.7 20.3 White Non-Hispanic/non -
Latino 08JUN2020
C4591001 1001
10011058 69 Female 161 69.1 26.7 Asian Non-Hispanic/non -
Latino 15JUN2020
C4591001 1001
10011061 68 Female 157.5 55.7 22.5 White Non-Hispanic/non -
Latino 15JUN2020
C4591001 1001
10011063 69 Female 157 62.1 25.2 White Non-Hispanic/non -
Latino 16JUN2020
C4591001 1002
10021059 77 Male 165.1 74.32 27.2 Asian Non-Hispanic/non -
Latino 04JUN2020
C4591001 1002
10021062 69 Female 161.29 71.14 27.3 White Non-Hispanic/non -
Latino 05JUN2020
C4591001 1002
10021063 73 Male 182.88 83.64 25 White Non-Hispanic/non -
Latino 05JUN2020
C4591001 1002
10021069 68 Female 170.18 58.98 20.3 White Non-Hispanic/non -
Latino 10JUN2020
C4591001 1002
10021074 73 Female 160.02 56.82 22.1 White Non-Hispanic/non -
Latino 12JUN2020
C4591001 1002
10021075 68 Male 181.61 80 24.2 White Non-Hispanic/non -
Latino 12JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 8
FDA-CBER-2021-5683-0029239
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1002
10021077 74 Female 158.12 64.77 25.9 White Non-Hispanic/non -
Latino 12JUN2020
Placebo 65-85 Placebo C4591001 1001
10011042 71 Female 159 47.9 18.9 White Non-Hispanic/non -
Latino 04JUN2020
C4591001 1001
10011053 69 Female 157.5 60.1 24.2 White Non-Hispanic/non -
Latino 11JUN2020
C4591001 1001
10011057 67 Female 168.4 74.8 26.4 White Non-Hispanic/non -
Latino 12JUN2020
C4591001 1001
10011064 70 Male 174 90.8 30 White Non-Hispanic/non -
Latino 16JUN2020
C4591001 1002
10021042 65 Female 165.1 59.55 21.8 White Non-Hispanic/non -
Latino 29MAY2020
C4591001 1002
10021047 65 Female 175.26 88.64 28.8 White Non-Hispanic/non -
Latino 01JUN2020
C4591001 1002
10021050 68 Female 161.93 78.64 29.9 White Hispanic/Latino 03JUN2020
C4591001 1002
10021072 65 Female 160.02 63.64 24.8 White Non-Hispanic/non -
Latino 11JUN2020
C4591001 1002
10021073 73 Female 167.64 50.45 17.9 White Non-Hispanic/non -
Latino 12JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 9
FDA-CBER-2021-5683-0029240
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
BNT162b2 18-55 10 μg C4591001 1003
10031018 53 Female 168.91 78.64 27.5 White Non-Hispanic/non -
Latino 01JUN2020
C4591001 1003
10031019 49 Female 160.02 56.82 22.1 White Non-Hispanic/non -
Latino 01JUN2020
C4591001 1003
10031020 40 Female 165.1 78.64 28.8 White Non-Hispanic/non -
Latino 01JUN2020
C4591001 1003
10031021 24 Male 172.72 60.45 20.2 White Hispanic/Latino 02JUN2020
C4591001 1003
10031022 28 Male 174.63 72.73 23.8 White Non-Hispanic/non -
Latino 03JUN2020
C4591001 1003
10031024 35 Male 187.96 100 28.2 White Non-Hispanic/non -
Latino 03JUN2020
C4591001 1007
10071014 50 Male 186.5 87 25 White Non-Hispanic/non -
Latino 02JUN2020
C4591001 1007
10071015 53 Male 169.4 64.4 22.4 White Non-Hispanic/non -
Latino 02JUN2020
C4591001 1007
10071016 24 Female 159.5 49.5 19.5 Asian Non-Hispanic/non -
Latino 02JUN2020
C4591001 1007
10071019 26 Female 181.6 78.8 23.9 White Non-Hispanic/non -
Latino 03JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 10
FDA-CBER-2021-5683-0029241
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1007
10071021 39 Female 163.5 70.5 26.4 White Non-Hispanic/non -
Latino 03JUN2020
C4591001 1007
10071022 21 Female 167.5 70.1 25 White Non-Hispanic/non -
Latino 03JUN2020
20 μg C4591001 1003
10031026 25 Male 175.26 73.64 23.9 White Non-Hispanic/non -
Latino 04JUN2020
C4591001 1003
10031027 48 Male 170.18 79.55 27.4 Black or African
American Non-Hispanic/non -
Latino 04JUN2020
C4591001 1003
10031028 29 Male 182.88 96.82 28.9 White Non-Hispanic/non -
Latino 04JUN2020
C4591001 1003
10031030 34 Female 168.91 68.64 24 White Non-Hispanic/non -
Latino 05JUN2020
C4591001 1003
10031032 37 Female 165.1 72.27 26.5 White Non-Hispanic/non -
Latino 05JUN2020
C4591001 1003
10031038 52 Male 176.53 76.82 24.6 White Non-Hispanic/non -
Latino 05JUN2020
C4591001 1007
10071017 42 Female 173.5 72.5 24.1 White Non-Hispanic/non -
Latino 02JUN2020
C4591001 1007
10071023 28 Female 157.5 59.6 24 White Hispanic/Latino 03JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 11
FDA-CBER-2021-5683-0029242
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1007
10071026 53 Female 175 89.5 29.2 Black or African
American Non-Hispanic/non -
Latino 03JUN2020
C4591001 1007
10071027 23 Male 184.5 84.8 24.9 White Non-Hispanic/non -
Latino 03JUN2020
C4591001 1007
10071029 39 Male 180 83.8 25.9 White Non-Hispanic/non -
Latino 03JUN2020
C4591001 1007
10071040 40 Female 163.2 62.6 23.5 White Non-Hispanic/non -
Latino 10JUN2020
30 μg C4591001 1003
10031057 35 Female 152.4 52.73 22.7 Asian Non-Hispanic/non -
Latino 10JUN2020
C4591001 1003
10031059 54 Male 185.42 83.64 24.3 White Non-Hispanic/non -
Latino 10JUN2020
C4591001 1003
10031061 26 Female 177.8 67.27 21.2 White Non-Hispanic/non -
Latino 12JUN2020
C4591001 1003
10031065 52 Female 170.18 70 24.1 White Non-Hispanic/non -
Latino 12JUN2020
C4591001 1003
10031066 44 Female 172.72 73.64 24.6 White Non-Hispanic/non -
Latino 12JUN2020
C4591001 1003
10031072 38 Female 165.1 62.73 23 White Non-Hispanic/non -
Latino 19JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 12
FDA-CBER-2021-5683-0029243
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1007
10071046 44 Female 164.5 53.1 19.6 Black or African
American Non-Hispanic/non -
Latino 11JUN2020
C4591001 1007
10071050 38 Female 169 64.6 22.6 Asian Non-Hispanic/non -
Latino 11JUN2020
C4591001 1007
10071058 35 Female 171 73.5 25.1 White Non-Hispanic/non -
Latino 15JUN2020
C4591001 1007
10071063 30 Male 182 91.3 27.6 White Non-Hispanic/non -
Latino 15JUN2020
C4591001 1007
10071064 28 Male 181 64.3 19.6 White Non-Hispanic/non -
Latino 15JUN2020
C4591001 1007
10071066 23 Female 159 72.3 28.6 White Non-Hispanic/non -
Latino 17JUN2020
Placebo 18-55 Placebo C4591001 1003
10031016 19 Male 184.15 101.36 29.8 White Non-Hispanic/non -
Latino 01JUN2020
C4591001 1003
10031017 52 Male 177.8 88.64 28 White Non-Hispanic/non -
Latino 01JUN2020
C4591001 1003
10031029 22 Female 154.94 56.36 23.4 White Non-Hispanic/non -
Latino 04JUN2020
C4591001 1003
10031034 44 Female 160.02 60.91 23.7 White Non-Hispanic/non -
Latino 05JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 13
FDA-CBER-2021-5683-0029244
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1003
10031050 41 Male 171.45 75.45 25.6 White Non-Hispanic/non -
Latino 08JUN2020
C4591001 1003
10031070 53 Male 172.72 69.09 23.1 White Non-Hispanic/non -
Latino 18JUN2020
C4591001 1007
10071020 30 Male 182.5 95.1 28.6 White Non-Hispanic/non -
Latino 03JUN2020
C4591001 1007
10071025 25 Female 171.8 71.9 24.4 White Non-Hispanic/non -
Latino 03JUN2020
C4591001 1007
10071065 24 Female 171.4 71.4 24.3 White Non-Hispanic/non -
Latino 15JUN2020
BNT162b2 65-85 10 μg C4591001 1003
10031076 71 Male 172.72 73.64 24.6 White Non-Hispanic/non -
Latino 23JUN2020
C4591001 1003
10031077 67 Female 157.48 49.55 19.9 White Non-Hispanic/non -
Latino 23JUN2020
C4591001 1003
10031078 69 Female 167.64 70.45 25 White Non-Hispanic/non -
Latino 24JUN2020
C4591001 1003
10031079 66 Female 157.48 62.73 25.2 White Non-Hispanic/non -
Latino 24JUN2020
C4591001 1003
10031080 65 Female 162.56 64.09 24.2 White Non-Hispanic/non -
Latino 25JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 14
FDA-CBER-2021-5683-0029245
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1003
10031087 66 Male 175.26 77.27 25.1 White Non-Hispanic/non -
Latino 25JUN2020
C4591001 1007
10071051 67 Female 167.9 57.2 20.3 White Non-Hispanic/non -
Latino 11JUN2020
C4591001 1007
10071057 73 Female 150 57.8 25.7 White Non-Hispanic/non -
Latino 15JUN2020
C4591001 1007
10071071 68 Female 163.5 71.8 26.9 White Non-Hispanic/non -
Latino 22JUN2020
C4591001 1007
10071073 65 Female 178 77.5 24.5 White Non-Hispanic/non -
Latino 22JUN2020
C4591001 1007
10071074 73 Female 175 81 26.4 White Non-Hispanic/non -
Latino 22JUN2020
C4591001 1007
10071077 66 Female 170.5 54.1 18.6 White Non-Hispanic/non -
Latino 24JUN2020
20 μg C4591001 1003
10031031 73 Female 182.88 61.36 18.3 White Non-Hispanic/non -
Latino 05JUN2020
C4591001 1003
10031035 69 Female 156.21 56.82 23.2 White Non-Hispanic/non -
Latino 05JUN2020
C4591001 1003
10031053 81 Female 165.1 61.36 22.5 White Non-Hispanic/non -
Latino 09JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 15
FDA-CBER-2021-5683-0029246
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1003
10031054 66 Female 170.18 82.73 28.5 White Non-Hispanic/non -
Latino 10JUN2020
C4591001 1003
10031055 67 Female 149.86 60 26.7 White Non-Hispanic/non -
Latino 10JUN2020
C4591001 1003
10031063 65 Female 157.48 63.18 25.4 White Non-Hispanic/non -
Latino 12JUN2020
C4591001 1007
10071031 77 Male 174.5 73.4 24.1 White Non-Hispanic/non -
Latino 08JUN2020
C4591001 1007
10071032 68 Male 189.5 90.3 25.1 White Non-Hispanic/non -
Latino 08JUN2020
C4591001 1007
10071035 81 Female 165 70.4 25.9 White Non-Hispanic/non -
Latino 08JUN2020
C4591001 1007
10071038 67 Male 179 76.4 23.8 White Non-Hispanic/non -
Latino 10JUN2020
C4591001 1007
10071039 66 Male 172 83.8 28.3 White Non-Hispanic/non -
Latino 10JUN2020
C4591001 1007
10071052 72 Male 168.5 69.9 24.6 White Non-Hispanic/non -
Latino 11JUN2020
30 μg C4591001 1003
10031037 70 Male 172.72 85.91 28.7 White Non-Hispanic/non -
Latino 05JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 16
FDA-CBER-2021-5683-0029247
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1003
10031047 69 Female 157.48 56.82 22.9 White Non-Hispanic/non -
Latino 08JUN2020
C4591001 1003
10031051 65 Male 173.99 76.36 25.2 White Non-Hispanic/non -
Latino 08JUN2020
C4591001 1003
10031058 74 Female 157.48 61.36 24.7 White Non-Hispanic/non -
Latino 10JUN2020
C4591001 1003
10031069 73 Male 177.8 78.18 24.7 White Non-Hispanic/non -
Latino 15JUN2020
C4591001 1007
10071034 69 Female 168.5 57.4 20.2 White Non-Hispanic/non -
Latino 08JUN2020
C4591001 1007
10071037 68 Female 167.5 73 26 White Non-Hispanic/non -
Latino 08JUN2020
C4591001 1007
10071043 65 Male 174.3 64.6 21.3 White Non-Hispanic/non -
Latino 11JUN2020
C4591001 1007
10071044 68 Female 169.3 81.7 28.5 White Non-Hispanic/non -
Latino 11JUN2020
C4591001 1007
10071045 66 Female 174.5 74.6 24.5 White Non-Hispanic/non -
Latino 11JUN2020
C4591001 1007
10071049 67 Male 178.5 94.3 29.6 White Non-Hispanic/non -
Latino 11JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 17
FDA-CBER-2021-5683-0029248
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1007
10071053 68 Male 183.5 80.1 23.8 White Non-Hispanic/non -
Latino 11JUN2020
Placebo 65-85 Placebo C4591001 1003
10031036 67 Male 170.18 68.18 23.5 White Non-Hispanic/non -
Latino 05JUN2020
C4591001 1003
10031043 68 Female 170.18 75.91 26.2 White Non-Hispanic/non -
Latino 05JUN2020
C4591001 1003
10031046 74 Female 154.94 53.18 22.1 White Non-Hispanic/non -
Latino 05JUN2020
C4591001 1003
10031056 71 Male 167.64 74.55 26.5 White Non-Hispanic/non -
Latino 10JUN2020
C4591001 1003
10031067 72 Male 167.64 71.36 25.3 White Non-Hispanic/non -
Latino 15JUN2020
C4591001 1003
10031083 67 Female 167.64 52.73 18.7 White Non-Hispanic/non -
Latino 25JUN2020
C4591001 1007
10071042 69 Female 160.3 70.7 27.5 White Non-Hispanic/non -
Latino 11JUN2020
C4591001 1007
10071056 65 Female 159.5 56.9 22.4 White Non-Hispanic/non -
Latino 15JUN2020
C4591001 1007
10071075 77 Male 178.2 81.6 25.7 White Non-Hispanic/non -
Latino 22JUN2020
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 18
FDA-CBER-2021-5683-0029249
Table 16.2.4.1 Listing of Demographic Characteristics – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
PFIZER CONFIDENTIAL SDTM Creation: 28AUG2020 (16:27) Source Data: adsl Table Generation: 29AUG2020 (08:28)
(Cutoff Date: 24AUG2020, Snapshot Date: 28AUG2020) Output File: (CDISC)/C4591001 IA P1/adsl l001 p1
090177e194d78552\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 19
FDA-CBER-2021-5683-0029250
Table 16.2.4.1.1 Listing of Demographic Characteristics – Phase 1 – BNT162b1 (100 μg )
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
BNT162b1 18-55 100 μg C4591001 1001
10011026 35 Male 174.5 88.1 28.9 White Non-Hispanic/non -
Latino 12MAY2020
C4591001 1001
10011028 53 Female 175.3 87.2 28.4 White Non-Hispanic/non -
Latino 12MAY2020
C4591001 1001
10011030 41 Female 164 51.4 19.1 White Non-Hispanic/non -
Latino 14MAY2020
C4591001 1001
10011032 35 Male 177 78.1 24.9 White Non-Hispanic/non -
Latino 15MAY2020
C4591001 1001
10011034 26 Female 161 46.1 17.8 Asian Non-Hispanic/non -
Latino 15MAY2020
C4591001 1002
10021023 25 Female 156.21 54.55 22.3 White Non-Hispanic/non -
Latino 05MAY2020
C4591001 1002
10021024 45 Female 165.1 57.27 21 White Non-Hispanic/non -
Latino 05MAY2020
C4591001 1002
10021027 30 Male 171.45 62.95 21.4 White Non-Hispanic/non -
Latino 05MAY2020
C4591001 1002
10021034 33 Male 190.5 87.05 23.9 White Non-Hispanic/non -
Latino 07MAY2020
C4591001 1002
10021035 42 Male 172.72 83.86 28.1 White Non-Hispanic/non -
Latino 07MAY2020
090177e194fbc504\Final\Final On: 22-Sep-2020 14:25 (GMT)
Page 20
FDA-CBER-2021-5683-0029251
Table 16.2.4.1.1 Listing of Demographic Characteristics – Phase 1 – BNT162b1 (100 μg )
Vaccine
Candidate Age
Group
(Years) Vaccine
Group
(as
Randomized) Subject Age
(Years) Sex Height
(cm) Weight
(kg) Body
Mass
Index
(BMI)
(kg/m2) Race Ethnicity Informed
Consent Date
(Screening)
C4591001 1002
10021036 42 Female 175.26 72.05 23.4 White Non-Hispanic/non -
Latino 07MAY2020
C4591001 1002
10021038 53 Female 167.64 68.18 24.2 White Non-Hispanic/non -
Latino 07MAY2020
Placebo 18-55 Placebo C4591001 1001
10011013 19 Female 163 58.1 21.9 White Non-Hispanic/non -
Latino 05MAY2020
C4591001 1001
10011021 31 Female 153.5 53.3 22.6 White Non-Hispanic/non -
Latino 07MAY2020
C4591001 1002
10021041 46 Male 170.18 78.18 26.9 White Non-Hispanic/non -
Latino 18MAY2020
PFIZER CONFIDENTIAL SDTM Creation: 28AUG2020 (16:27) Source Data: adsl Table Generation: 18SEP2020 (12:30)
(Cutoff Date: 24AUG2020, Snapshot Date: 28AUG2020) Output File: ./nda3/C4591001_IA_P1_100/adsl_l001_100_p1
090177e194fbc504\Final\Final On: 22-Sep-2020 14:25 (GMT)
Page 21
FDA-CBER-2021-5683-0029252
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
16-55 C4591001 1001
1001108333 Female 161.9 50.6 19.3 White Non-Hispanic/non -
Latino28JUL2020
C4591001 1001
1001108525 Female 174.3 53.4 17.6 White Non-Hispanic/non -
Latino28JUL2020
C4591001 1001
1001108652 Male 172.7 68.9 23.1 White Non-Hispanic/non -
Latino28JUL2020
C4591001 1001
1001108745 Male 175 83.1 27.1 White Non-Hispanic/non -
Latino28JUL2020
C4591001 1001
1001108844 Female 161.9 49.8 19 Asian Non-Hispanic/non -
Latino28JUL2020
C4591001 1001
1001108937 Female 165 74.1 27.2 Not reported Non-Hispanic/non -
Latino28JUL2020
C4591001 1001
1001109145 Male 172 78.2 26.4 White Non-Hispanic/non -
Latino29JUL2020
C4591001 1001
1001109245 Male 170.7 67 23 Asian Non-Hispanic/non -
Latino29JUL2020
C4591001 1001
1001109539 Male 181.3 75 22.8 White Non-Hispanic/non -
Latino29JUL2020
C4591001 1001
1001110128 Male 185.5 132.5 38.5 Black or African American Hispanic/Latino 30JUL2020
C4591001 1001
1001110226 Female 166.2 59 21.4 Not reported Hispanic/Latino 30JUL2020
C4591001 1001
1001110527 Male 181.7 68.4 20.7 White Non-Hispanic/non -
Latino31JUL2020
C4591001 1001
1001110644 Male 204.5 115.5 27.6 Black or African American Non-Hispanic/non -
Latino31JUL2020
C4591001 1001
1001110752 Male 180.3 98.2 30.2 White Non-Hispanic/non -
Latino31JUL2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 22
FDA-CBER-2021-5683-0029253
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1001
1001111354 Male 180.3 72.6 22.3 White Not reported 03AUG2020
C4591001 1001
1001112523 Female 156.2 46.8 19.2 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1001
1001112648 Female 163 57.6 21.7 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1001
1001112948 Male 184.2 86.3 25.4 White Non-Hispanic/non -
Latino05AUG2020
C4591001 1001
1001113055 Male 167.6 81 28.8 White Hispanic/Latino 05AUG2020
C4591001 1001
1001113142 Female 162.6 83.2 31.5 White Non-Hispanic/non -
Latino05AUG2020
C4591001 1001
1001113236 Male 178.4 104.1 32.7 White Non-Hispanic/non -
Latino05AUG2020
C4591001 1001
1001113545 Female 169 56.5 19.8 White Non-Hispanic/non -
Latino05AUG2020
C4591001 1001
1001113653 Female 159 62.4 24.7 White Non-Hispanic/non -
Latino06AUG2020
C4591001 1001
1001113841 Male 176 77 24.9 White Non-Hispanic/non -
Latino06AUG2020
C4591001 1001
1001114333 Male 185.4 88.7 25.8 Black or African American Hispanic/Latino 06AUG2020
C4591001 1001
1001114531 Female 155.4 65.5 27.1 Black or African American Hispanic/Latino 07AUG2020
C4591001 1001
1001114638 Male 190.5 89.8 24.7 Black or African American Hispanic/Latino 07AUG2020
C4591001 1001
1001114934 Female 167.6 51.3 18.3 White Hispanic/Latino 07AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 23
FDA-CBER-2021-5683-0029254
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1003
1003108826 Female 165.1 58.64 21.5 White Non-Hispanic/non -
Latino27JUL2020
C4591001 1003
1003109045 Female 152.4 96.36 41.4 White Non-Hispanic/non -
Latino27JUL2020
C4591001 1003
1003109442 Male 180.34 108.64 33.3 White Non-Hispanic/non -
Latino28JUL2020
C4591001 1003
1003109628 Male 167.64 82.27 29.2 Black or African American Non-Hispanic/non -
Latino28JUL2020
C4591001 1003
1003109751 Female154.94 70.45 29.3 White Non-Hispanic/non -
Latino28JUL2020
C4591001 1003
1003110042 Male 185.42 121.82 35.4 White Non-Hispanic/non -
Latino28JUL2020
C4591001 1003
1003110143 Male 180.34 84.55 25.9 White Non-Hispanic/non -
Latino28JUL2020
C4591001 1003
1003110442 Male 172.72 86.18 28.8 White Non-Hispanic/non -
Latino29JUL2020
C4591001 1003
1003111125 Male 180.34 81.82 25.1 White Non-Hispanic/non -
Latino30JUL2020
C4591001 1003
1003111538 Female162.56 50.91 19.2 Asian Non-Hispanic/non -
Latino30JUL2020
C4591001 1003
1003111642 Female160.02 67.73 26.4 White Non-Hispanic/non -
Latino30JUL2020
C4591001 1003
1003112248 Male 165.1 102.27 37.4 White Non-Hispanic/non -
Latino31JUL2020
C4591001 1003
1003112423 Female160.02 51.36 20 White Non-Hispanic/non -
Latino31JUL2020
C4591001 1003
1003112534 Female 165.1 104.55 38.3 White Non-Hispanic/non -
Latino31JUL2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 24
FDA-CBER-2021-5683-0029255
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1003
1003113741 Male 180.34 98.64 30.3 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1003
1003113854 Female160.02 56.36 22 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1003
1003114132 Male 185.42 77.27 22.4 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1003
1003114453 Male 180.34 97.73 30 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1003
1003114639 Male 187.96 84.09 23.8 White Non-Hispanic/non -
Latino05AUG2020
C4591001 1003
1003114738 Female175.26 92.73 30.1 White Non-Hispanic/non -
Latino05AUG2020
C4591001 1003
1003115155 Male 182.88 81.82 24.4 White Non-Hispanic/non -
Latino05AUG2020
C4591001 1003
1003115531 Male 177.8 127.27 40.2 White Non-Hispanic/non -
Latino06AUG2020
C4591001 1003
1003115651 Female175.26 84.09 27.3 White Non-Hispanic/non -
Latino06AUG2020
C4591001 1003
1003115850 Male 187.96 95.91 27.1 White Non-Hispanic/non -
Latino06AUG2020
C4591001 1003
1003116026 Male 170.18 68.18 23.5 Asian Non-Hispanic/non -
Latino06AUG2020
C4591001 1003
1003116155 Female167.64 129.09 45.8 White Non-Hispanic/non -
Latino07AUG2020
C4591001 1003
1003116255 Female154.94 76.82 31.9 White Non-Hispanic/non -
Latino07AUG2020
C4591001 1003
1003116651 Male 182.88 136.36 40.7 White Non-Hispanic/non -
Latino07AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 25
FDA-CBER-2021-5683-0029256
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1003
1003117033 Female172.72 72.73 24.3 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1003
1003117138 Male 154.94 59.09 24.6 Asian Non-Hispanic/non -
Latino10AUG2020
C4591001 1003
1003117433 Male 182.88 93.18 27.8 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1003
1003117554 Female160.02 70.45 27.5 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1003
1003117744 Female172.72 81.82 27.4 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1003
1003117940 Male 172.72 79.55 26.6 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1003
1003118043 Female154.94 46.82 19.5 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1003
1003118327 Female167.64 63.64 22.6 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1003
1003118452 Male 180.34 75.45 23.1 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1003
1003118633 Male 182.88 143.18 42.7 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1003
1003118734 Male 175.26 72.73 23.6 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1003
1003119041 Male 160.02 120.45 46.9 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1003
1003119127 Female 165.1 90.91 33.3 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1003
1003119439 Male 172.72 102.27 34.2 White Non-Hispanic/non -
Latino13AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 26
FDA-CBER-2021-5683-0029257
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1003
1003119644 Female 152.4 47.73 20.5 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1003
1003119741 Male 182.88 81.82 24.4 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1003
1003119853 Female 152.4 65.91 28.3 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1003
1003119937 Female160.02 60.45 23.6 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1003
1003120155 Female 165.1 127.27 46.6 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1003
1003120350 Female170.18 79.55 27.4 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1003
1003120439 Female160.02 54.55 21.3 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1003
1003120552 Female162.56 96.36 36.4 Black or African American Non-Hispanic/non -
Latino14AUG2020
C4591001 1003
1003120653 Male 175.26 78.64 25.5 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1003
1003120753 Male 180.34 123.18 37.8 Black or African American Non-Hispanic/non -
Latino14AUG2020
C4591001 1005
1005100251 Female170.18 83.64 28.8 White Non-Hispanic/non -
Latino07AUG2020
C4591001 1005
1005100326 Male 180.34 78.82 24.2 White Non-Hispanic/non -
Latino07AUG2020
C4591001 1005
1005100446 Male 186.69 85.91 24.6 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1005
1005100754 Female157.48 71.73 28.9 White Non-Hispanic/non -
Latino10AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 27
FDA-CBER-2021-5683-0029258
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1005
1005100842 Female161.29 88.05 33.8 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1005
1005101545 Male 177.8 79 24.9 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1005
1005101653 Male 168.91 97.5 34.1 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1005
1005101737 Female160.02 62.27 24.3 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1005
1005102423 Male 180.34 88.27 27.1 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1005
1005102641 Male 172.72 72.73 24.3 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1005
1005102751 Male 167.64 83.55 29.7 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1005
1005102852 Female160.02 65.73 25.6 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1005
1005102950 Male 187.96 89.45 25.3 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1005
1005103055 Male 179.07 89.09 27.7 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1005
1005103151 Male 185.42 81.55 23.7 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1005
1005103530 Male 172.72 108 36.1 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1005
1005103622 Male 177.8 125.45 39.6 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1005
1005104145 Female162.56 101.59 38.4 White Non-Hispanic/non -
Latino12AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 28
FDA-CBER-2021-5683-0029259
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1005
1005104839 Female172.72 71.82 24 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1005
1005105155 Male 170.18 83.18 28.7 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1005
1005105225 Male 180.34 67.45 20.7 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1005
1005105454 Female167.64 137.55 48.8 Black or African American Non-Hispanic/non -
Latino13AUG2020
C4591001 1005
1005105533 Female154.94 84 34.9 Asian Non-Hispanic/non -
Latino13AUG2020
C4591001 1005
1005105742 Female154.94 112.27 46.7 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1005
1005105938 Female162.56 128.64 48.6 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1005
1005106640 Female162.56 70.45 26.6 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1005
1005106751 Male 179.07 97 30.2 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1005
1005107037 Male 180.34 92.73 28.4 Asian Non-Hispanic/non -
Latino14AUG2020
C4591001 1005
1005107122 Male 182.88 87 26 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1005
1005107344 Male 177.8 95.91 30.3 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1005
1005107530 Female172.72 107.55 36 Black or African American Non-Hispanic/non -
Latino14AUG2020
C4591001 1005
1005107641 Male 177.8 129.27 40.8 White Non-Hispanic/non -
Latino17AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 29
FDA-CBER-2021-5683-0029260
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1005
1005107744 Female167.64 78.64 27.9 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1005
1005107944 Male 172.72 100.27 33.5 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1005
1005108144 Female170.18 66.36 22.9 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1005
1005108228 Female162.56 66.82 25.2 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1005
1005108452 Male 170.18 85.18 29.3 Asian Non-Hispanic/non -
Latino19AUG2020
C4591001 1005
1005108541 Female 165.1 109.55 40.1 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1005
1005108732 Female 165.1 72.73 26.6 White Hispanic/Latino 20AUG2020
C4591001 1005
1005109335 Female175.26 83.36 27.1 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1005
1005109435 Female160.02 56.91 22.2 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1005
1005110037 Male 187.96 116.82 33 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1005
1005110135 Male 177.8 89.36 28.2 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1005
1005110550 Female162.56 65.09 24.6 White Non-Hispanic/non -
Latino21AUG2020
C4591001 1005
1005110638 Male 193.04 110.36 29.6 White Non-Hispanic/non -
Latino21AUG2020
C4591001 1005
1005110735 Male 187.96 91.36 25.8 White Non-Hispanic/non -
Latino21AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 30
FDA-CBER-2021-5683-0029261
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1005
1005110839 Male 175.26 89.91 29.2 White Non-Hispanic/non -
Latino21AUG2020
C4591001 1005
1005111526 Female157.48 63.91 25.7 American Indian or Alaska
native Non-Hispanic/non -
Latino21AUG2020
C4591001 1005
1005111737 Female175.26 134.45 43.7 White Non-Hispanic/non -
Latino21AUG2020
C4591001 1005
1005111851 Male 175.26 122.36 39.7 White Non-Hispanic/non -
Latino21AUG2020
C4591001 1005
1005111948 Male 187.96 104.55 29.5 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1005
1005112351 Female172.72 101 33.8 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1005
1005112554 Female162.56 64 24.2 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1005
1005112951 Female167.64 58.45 20.8 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1005
1005113440 Female162.56 62.82 23.7 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1005
1005113528 Female172.72 118.82 39.7 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1005
1005114242 Male 187.96 120.36 34 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1005
1005114448 Male 193.04 141.64 37.9 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1005
1005114547 Female162.56 75.82 28.6 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1005
1005114647 Male 182.88 87.55 26.1 White Hispanic/Latino 25AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 31
FDA-CBER-2021-5683-0029262
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1005
1005114722 Female172.72 67.82 22.7 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1005
1005114852 Male 172.72 157.09 52.5 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1005
1005115052 Male 182.88 127.09 37.9 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1005
1005115149 Female170.18 82.82 28.5 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1005
1005115345 Female162.56 69.09 26.1 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1005
1005116152 Male 187.96 97.73 27.6 White Hispanic/Latino 26AUG2020
C4591001 1005
1005116448 Male 170.18 70.82 24.4 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1005
1005116553 Male 180.34 87.09 26.7 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1005
1005116647 Male 185.42 108.73 31.6 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1005
1005116755 Female181.61 80.45 24.3 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1005
1005116849 Male 177.8 84.05 26.5 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1005
1005116934 Female 165.1 79.27 29 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1005
1005117031 Male 189.23 92.64 25.8 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1005
1005117138 Female160.02 73 28.4 White Non-Hispanic/non -
Latino27AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 32
FDA-CBER-2021-5683-0029263
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1005
1005117544 Female 165.1 59.77 21.9 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1005
1005117852 Male 180.34 86.36 26.5 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1005
1005117949 Female170.18 78.82 27.2 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1005
1005118155 Female162.56 67.91 25.6 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1005
1005118245 Female160.02 63.27 24.7 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1005
1005118351 Male 187.96 114.91 32.5 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1005
1005118744 Female 165.1 118 43.2 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1005
1005118854 Male 182.88 81.45 24.3 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1005
1005118952 Female 177.8 82.05 25.9 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1005
1005119240 Female167.64 81.64 29 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1005
1005119819 Female160.02 68.91 26.9 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1005
1005119948 Female162.56 93.18 35.2 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1005
1005120038 Male 187.96 74.55 21.1 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1005
1005120336 Male 190.5 95.68 26.3 White Non-Hispanic/non -
Latino03SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 33
FDA-CBER-2021-5683-0029264
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1005
1005121029 Male 172.72 83.18 27.8 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1005
1005121228 Male 182.88 118.18 35.3 Black or African American Non-Hispanic/non -
Latino03SEP2020
C4591001 1005
1005121551 Male 170.18 76.36 26.3 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1005
1005121619 Female160.02 78.55 30.6 White Hispanic/Latino 03SEP2020
C4591001 1005
1005121720 Female162.56 79 29.8 White Hispanic/Latino 03SEP2020
C4591001 1005
1005121953 Male 177.8 83.91 26.5 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1005
1005122034 Female 165.1 76.55 28 White Non-Hispanic/non -
Latino12OCT2020
C4591001 1005
1005122127 Male 179.07 87.36 27.2 White Non-Hispanic/non -
Latino12OCT2020
C4591001 1005
1005122251 Female149.86 45.91 20.4 White Non-Hispanic/non -
Latino12OCT2020
C4591001 1005
1005122342 Male 187.96 94.36 26.7 White Non-Hispanic/non -
Latino12OCT2020
C4591001 1005
1005122449 Female162.56 69.36 26.2 White Non-Hispanic/non -
Latino12OCT2020
C4591001 1005
1005122530 Female162.56 74.27 28 White Non-Hispanic/non -
Latino12OCT2020
C4591001 1005
1005122641 Female173.99 94.36 31.1 White Non-Hispanic/non -
Latino12OCT2020
C4591001 1005
1005122829 Female171.45 76.09 25.8 White Non-Hispanic/non -
Latino12OCT2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 34
FDA-CBER-2021-5683-0029265
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1005
1005123243 Female172.72 84.82 28.4 White Non-Hispanic/non -
Latino12OCT2020
C4591001 1005
1005123343 Male 179.07 75.55 23.5 White Non-Hispanic/non -
Latino12OCT2020
C4591001 1005
1005123549 Female166.37 79.36 28.6 White Non-Hispanic/non -
Latino12OCT2020
C4591001 1005
1005123625 Male 177.8 83.45 26.3 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1005
1005123749 Female165.86 64.45 23.4 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1005
1005123820 Male 173.48 70.55 23.4 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1005
1005124048 Male 170.43 67.27 23.1 Black or African American Non-Hispanic/non -
Latino13OCT2020
C4591001 1005
1005124154 Female159.51 75.82 29.7 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1005
1005124250 Male 177.8 90.91 28.7 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1005
1005124355 Male 172.72 78.55 26.3 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1005
1005124432 Female175.26 70.18 22.8 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1005
1005124536 Male 186.18 141.36 40.7 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1005
1005124649 Male 176.78 79.27 25.3 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1005
1005124846 Male 165.1 72 26.4 White Non-Hispanic/non -
Latino14OCT2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 35
FDA-CBER-2021-5683-0029266
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1005
1005125142 Female167.13 72.73 26 White Non-Hispanic/non -
Latino14OCT2020
C4591001 1005
1005125448 Female162.56 66.64 25.2 White Non-Hispanic/non -
Latino14OCT2020
C4591001 1005
1005125754 Female167.64 46.82 16.6 White Non-Hispanic/non -
Latino14OCT2020
C4591001 1005
1005125955 Female163.83 76.36 28.4 White Non-Hispanic/non -
Latino14OCT2020
C4591001 1005
1005126052 Female167.64 64.82 23 White Non-Hispanic/non -
Latino14OCT2020
C4591001 1005
1005126424 Female 165.1 54.27 19.9 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1005
1005126748 Female165.86 83.55 30.3 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1005
1005126836 Male 182.37 76.27 22.9 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1005
1005127033 Male 175.26 104.27 33.9 Black or African American Non-Hispanic/non -
Latino15OCT2020
C4591001 1005
1005127316 Female162.56 55.45 20.9 Multiracial Non-Hispanic/non -
Latino15OCT2020
C4591001 1005
1005127436 Female167.64 111.27 39.5 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1005
1005127655 Female 171.2 95.18 32.4 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1005
1005127751 Male 177.8 84.27 26.6 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1005
1005128051 Female160.02 62.55 24.4 White Non-Hispanic/non -
Latino16OCT2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 36
FDA-CBER-2021-5683-0029267
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1005
1005128150 Female160.02 64.91 25.3 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1005
1005128324 Female163.83 69.45 25.8 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1005
1005128538 Female156.85 95 38.5 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1005
1005128836 Female160.78 76.73 29.6 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1005
1005128954 Female162.56 122.82 46.4 Black or African American Non-Hispanic/non -
Latino16OCT2020
C4591001 1005
1005129048 Female175.26 76.36 24.8 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1005
1005129133 Male 172.72 79.73 26.7 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1005
1005129246 Male 180.34 97.18 29.8 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1005
1005129436 Female166.37 97.73 35.2 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1005
1005129516 Male 173.48 70.18 23.3 White Hispanic/Latino 19OCT2020
C4591001 1005
1005130155 Male 180.34 113 34.7 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1005
1005130254 Male 176.53 82.27 26.3 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1005
1005130829 Female168.91 131.18 45.9 Black or African American Non-Hispanic/non -
Latino19OCT2020
C4591001 1005
1005131054 Female167.64 104.91 37.2 White Hispanic/Latino 19OCT2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 37
FDA-CBER-2021-5683-0029268
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1005
1005131149 Male 174.63 80.64 26.4 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1005
1005131447 Male 167.89 122.45 43.3 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1005
1005131552 Male 179.32 84.82 26.3 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1005
1005131646 Female156.97 99.45 40.3 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1005
1005131839 Male 189.23 113.18 31.5 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1005
1005132238 Male 187.45 123.55 35.1 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1005
1005132355 Female 165.1 81.45 29.8 Black or African American Non-Hispanic/non -
Latino20OCT2020
C4591001 1005
1005132639 Female164.59 79.45 29.3 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1005
1005133136 Male 175.26 85.64 27.8 White Hispanic/Latino 20OCT2020
C4591001 1005
1005133251 Male 172.97 76.73 25.6 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1005
1005133551 Male 191.01 93.27 25.5 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1005
1005134040 Female178.82 161.82 50.5 Black or African American Hispanic/Latino 21OCT2020
C4591001 1005
1005134123 Female171.45 88.45 30 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1005
1005134319 Male 187.96 87.09 24.6 White Non-Hispanic/non -
Latino21OCT2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 38
FDA-CBER-2021-5683-0029269
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1005
1005134537 Male 183.13 107.36 31.9 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1005
1005134626 Female173.99 89.55 29.5 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1005
1005134946 Female167.64 71.55 25.4 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1005
1005135042 Female156.97 64 25.9 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1005
1005135433 Male 182.88 95.82 28.6 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1005
1005135647 Male 186.18 102.09 29.4 Black or African American Non-Hispanic/non -
Latino22OCT2020
C4591001 1005
1005135742 Female172.21 70 23.6 Black or African American Non-Hispanic/non -
Latino22OCT2020
C4591001 1005
1005135852 Female170.18 74.27 25.6 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1005
1005136140 Male 175.26 82 26.6 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1005
1005136241 Female162.56 62.82 23.7 White Non-Hispanic/non -
Latino23OCT2020
C4591001 1005
1005136350 Male 176.02 76.73 24.7 White Non-Hispanic/non -
Latino23OCT2020
C4591001 1005
1005136441 Female168.91 72.73 25.4 White Non-Hispanic/non -
Latino23OCT2020
C4591001 1005
1005136536 Female170.18 92.45 31.9 White Non-Hispanic/non -
Latino23OCT2020
C4591001 1005
1005136654 Male 177.8 76.77 24.2 White Non-Hispanic/non -
Latino23OCT2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 39
FDA-CBER-2021-5683-0029270
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1005
1005136854 Male 177.8 91.91 29 White Non-Hispanic/non -
Latino23OCT2020
C4591001 1005
1005136954 Female153.16 98.64 42 White Non-Hispanic/non -
Latino26OCT2020
C4591001 1005
1005137044 Female153.16 62.09 26.4 Asian Non-Hispanic/non -
Latino26OCT2020
C4591001 1005
1005137117 Male 183.64 74.73 22.1 White Non-Hispanic/non -
Latino26OCT2020
C4591001 1005
1005137752 Male 179.71 102.09 31.5 White Non-Hispanic/non -
Latino27OCT2020
C4591001 1005
1005137855 Female157.48 97.55 39.2 White Non-Hispanic/non -
Latino27OCT2020
C4591001 1005
1005138054 Male 179.83 86.82 26.8 White Non-Hispanic/non -
Latino27OCT2020
C4591001 1005
1005138537 Female172.72 67.27 22.5 White Non-Hispanic/non -
Latino28OCT2020
C4591001 1005
1005138633 Female172.72 83.27 27.9 White Non-Hispanic/non -
Latino28OCT2020
C4591001 1005
1005139038 Female170.18 117.55 40.5 White Non-Hispanic/non -
Latino30OCT2020
C4591001 1005
1005139319 Male 172.21 78.64 26.5 White Non-Hispanic/non -
Latino30OCT2020
C4591001 1005
1005139417 Male 177.29 83.64 26.5 White Non-Hispanic/non -
Latino02NOV2020
C4591001 1005
1005139655 Female166.37 60 21.6 White Non-Hispanic/non -
Latino02NOV2020
C4591001 1005
1005139753 Female163.83 56.91 21.2 White Non-Hispanic/non -
Latino02NOV2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 40
FDA-CBER-2021-5683-0029271
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1005
1005139816 Female171.45 59.64 20.2 White Non-Hispanic/non -
Latino03NOV2020
C4591001 1005
1005140017 Male 181.1 66.18 20.1 White Non-Hispanic/non -
Latino03NOV2020
C4591001 1005
1005140749 Female160.53 58.64 22.7 White Non-Hispanic/non -
Latino11NOV2020
C4591001 1005
1005140816 Male 187.96 93 26.3 White Non-Hispanic/non -
Latino11NOV2020
C4591001 1006
1006100535 Female154.94 50 20.8 Asian Non-Hispanic/non -
Latino10AUG2020
C4591001 1006
1006100735 Female180.34 110 33.7 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1006
1006100849 Male 171.45 79.18 26.9 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1006
1006100929 Female163.83 75.55 28.1 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1006
1006101146 Female 165.1 65 23.8 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1006
1006101253 Male 187.96 120.14 33.9 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1006
1006101321 Female157.48 68.18 27.4 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1006
1006101449 Female162.56 66.82 25.2 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1006
1006101529 Male 177.8 93.18 29.4 Asian Non-Hispanic/non -
Latino11AUG2020
C4591001 1006
1006101832 Male 172.72 67.82 22.7 White Non-Hispanic/non -
Latino11AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 41
FDA-CBER-2021-5683-0029272
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1006
1006101951 Male 182.88 79.55 23.7 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1006
1006102141 Female157.48 61.91 24.9 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1006
1006102245 Male 187.96 111.36 31.5 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1006
1006102342 Male 177.8 81.82 25.8 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1006
1006102444 Female162.56 75.64 28.6 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1006
1006102840 Female153.67 77.27 32.7 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1006
1006103120 Male 180.34 104.55 32.1 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1006
1006103246 Female171.45 95.45 32.4 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1006
1006103323 Female163.83 80.18 29.8 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1006
1006103640 Female172.72 118.82 39.7 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1006
1006103751 Male 193.04 108.64 29.1 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1006
1006104026 Female 152.4 76.36 32.8 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1006
1006104127 Male 170.18 66 22.7 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1006
1006104325 Male 182.88 89.23 26.6 White Non-Hispanic/non -
Latino17AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 42
FDA-CBER-2021-5683-0029273
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1006
1006105050 Male 182.88 110 32.8 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1006
1006105236 Male 179.07 109.55 34.1 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1006
1006105331 Male 177.8 77.27 24.4 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1006
1006105450 Female166.37 70.45 25.4 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1006
1006105535 Male 193.04 86.73 23.2 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1006
1006105627 Male 175.26 68.36 22.2 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1006
1006105734 Male 175.26 95.45 31 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1006
1006106142 Female179.07 88.82 27.6 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1006
1006106224 Male 181.61 70 21.2 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1006
1006106639 Female176.53 82.82 26.5 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1006
1006106732 Male 186.18 98.73 28.4 White Hispanic/Latino 19AUG2020
C4591001 1006
1006106830 Male 177.8 101.91 32.2 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1006
1006107033 Male 172.72 106.82 35.7 Multiracial Non-Hispanic/non -
Latino19AUG2020
C4591001 1006
1006107118 Male 191.26 62.82 17.1 White Non-Hispanic/non -
Latino19AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 43
FDA-CBER-2021-5683-0029274
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1006
1006107326 Male 170.82 69.27 23.7 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1006
1006107426 Female160.02 78.91 30.7 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1006
1006107542 Female167.64 68.77 24.4 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1006
1006107848 Female157.48 51.73 20.8 Asian Non-Hispanic/non -
Latino20AUG2020
C4591001 1006
1006107947 Female175.26 64.09 20.8 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1006
1006108118 Female 177.8 181.27 57.2 Multiracial Non-Hispanic/non -
Latino20AUG2020
C4591001 1006
1006108427 Female161.29 66.18 25.4 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1006
1006108823 Female 165.1 61.27 22.4 White Non-Hispanic/non -
Latino21AUG2020
C4591001 1006
1006108953 Female173.99 85.55 28.2 White Hispanic/Latino 21AUG2020
C4591001 1006
1006109034 Female156.97 70.27 28.5 White Non-Hispanic/non -
Latino21AUG2020
C4591001 1006
1006109120 Female 165.1 99.55 36.4 Asian Non-Hispanic/non -
Latino21AUG2020
C4591001 1006
1006109227 Male 173.99 109.45 36.1 Black or African American Hispanic/Latino 21AUG2020
C4591001 1006
1006109334 Male 177.8 89 28.1 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1006
1006109435 Female175.26 62.55 20.3 White Non-Hispanic/non -
Latino24AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 44
FDA-CBER-2021-5683-0029275
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1006
1006109527 Female157.48 50.09 20.2 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1006
1006109639 Female161.29 65.55 25.1 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1006
1006109930 Male 177.8 94.86 29.9 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1006
1006110042 Male 190.5 118.73 32.6 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1006
1006110242 Female156.21 62.27 25.5 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1006
1006110340 Male 186.69 91 26.1 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1006
1006110424 Female163.83 75.91 28.2 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1006
1006110627 Female175.26 66 21.4 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1006
1006110741 Female168.28 63.73 22.5 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1006
1006110835 Female160.66 73.27 28.3 American Indian or Alaska
native Hispanic/Latino 25AUG2020
C4591001 1006
1006110936 Male 185.42 106.27 30.8 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1006
1006111030 Male 172.72 68.64 23 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1006
1006111250 Female161.29 50 19.2 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1006
1006111330 Male 187.96 82 23.2 White Non-Hispanic/non -
Latino26AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 45
FDA-CBER-2021-5683-0029276
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1006
1006111421 Male 175.9 147.05 47.4 White Hispanic/Latino 26AUG2020
C4591001 1006
1006111649 Male 187.96 84.36 23.8 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1006
1006111744 Female 165.1 72.55 26.6 White Hispanic/Latino 26AUG2020
C4591001 1006
1006111827 Male 184.15 115.64 34 White Hispanic/Latino 27AUG2020
C4591001 1006
1006112239 Male 182.88 99.09 29.6 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1006
1006112430 Female167.64 56.36 20 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1006
1006112852 Female157.48 93.45 37.6 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1006
1006112943 Female167.64 68.36 24.3 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1006
1006113023 Female162.56 45.27 17.1 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1006
1006113123 Male 180.34 73.82 22.6 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1006
1006113333 Male 172.72 78.27 26.2 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1006
1006113450 Female157.48 45.64 18.4 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1006
1006113623 Female162.56 86.18 32.5 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1006
1006113723 Male 180.34 114.82 35.2 White Non-Hispanic/non -
Latino01SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 46
FDA-CBER-2021-5683-0029277
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1006
1006113830 Male 171.45 70.18 23.8 Black or African American Non-Hispanic/non -
Latino02SEP2020
C4591001 1006
1006114036 Male 162.56 74.18 28 Asian Non-Hispanic/non -
Latino02SEP2020
C4591001 1006
1006114119 Female170.18 50.82 17.5 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1006
1006114250 Female175.26 79.27 25.8 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1006
1006114447 Female172.72 67.64 22.6 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1006
1006114832 Female160.02 57.18 22.3 White Non-Hispanic/non -
Latino11SEP2020
C4591001 1006
1006115141 Female 177.8 102.73 32.4 White Non-Hispanic/non -
Latino22SEP2020
C4591001 1006
1006115252 Male 177.8 96.09 30.3 White Non-Hispanic/non -
Latino22SEP2020
C4591001 1006
1006115321 Female163.83 77.27 28.7 White Non-Hispanic/non -
Latino23SEP2020
C4591001 1006
1006115416 Male 186.69 66.45 19 White Non-Hispanic/non -
Latino23SEP2020
C4591001 1006
1006115516 Female157.48 46.55 18.7 White Non-Hispanic/non -
Latino23SEP2020
C4591001 1006
1006115616 Female168.91 71.91 25.1 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1006
1006115920 Female162.56 62.36 23.5 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1006
1006116052 Female170.18 87.27 30.1 White Non-Hispanic/non -
Latino25SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 47
FDA-CBER-2021-5683-0029278
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1006
1006116129 Female186.69 69.18 19.8 White Non-Hispanic/non -
Latino25SEP2020
C4591001 1006
1006116217 Male 177.17 56.91 18.1 White Non-Hispanic/non -
Latino25SEP2020
C4591001 1006
1006116338 Female166.37 82.36 29.7 White Non-Hispanic/non -
Latino25SEP2020
C4591001 1006
1006116417 Female167.64 85.36 30.3 White Non-Hispanic/non -
Latino25SEP2020
C4591001 1006
1006116545 Female162.56 75.36 28.5 White Non-Hispanic/non -
Latino25SEP2020
C4591001 1006
1006116643 Male 187.96 86.55 24.4 White Non-Hispanic/non -
Latino25SEP2020
C4591001 1006
1006116717 Female172.72 58.18 19.5 White Hispanic/Latino 28SEP2020
C4591001 1006
1006116917 Male 182.88 110.09 32.8 White Non-Hispanic/non -
Latino02OCT2020
C4591001 1006
1006117016 Male 182.88 57.55 17.2 White Non-Hispanic/non -
Latino05OCT2020
C4591001 1006
1006117116 Male 182.88 90.36 27 White Non-Hispanic/non -
Latino08OCT2020
C4591001 1006
1006117316 Female167.64 79.36 28.2 Native Hawaiian or other
Pacific IslanderNon-Hispanic/non -
Latino09OCT2020
C4591001 1006
1006117417 Male 170.18 53.91 18.6 American Indian or Alaska
native Hispanic/Latino 12OCT2020
C4591001 1006
1006117616 Female160.02 63.77 24.9 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1006
1006117943 Male 175.26 66.18 21.5 White Hispanic/Latino 30OCT2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 48
FDA-CBER-2021-5683-0029279
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1006
1006118017 Female160.02 58.18 22.7 White Non-Hispanic/non -
Latino06NOV2020
C4591001 1006
1006118117 Female 177.8 60.45 19.1 White Non-Hispanic/non -
Latino13NOV2020
C4591001 1007
1007108046 Male 176.4 86.4 27.8 Asian Non-Hispanic/non -
Latino28JUL2020
C4591001 1007
1007108225 Female 175.2 118.8 38.7 Black or African American Non-Hispanic/non -
Latino28JUL2020
C4591001 1007
1007108354 Male 179 85.1 26.6 Black or African American Non-Hispanic/non -
Latino28JUL2020
C4591001 1007
1007108729 Female 162.4 78.6 29.8 White Non-Hispanic/non -
Latino29JUL2020
C4591001 1007
1007108949 Female 184.5 116 34.1 White Non-Hispanic/non -
Latino29JUL2020
C4591001 1007
1007109249 Male 183 117.3 35 White Non-Hispanic/non -
Latino29JUL2020
C4591001 1007
1007109337 Male 181.5 92.2 28 Black or African American Non-Hispanic/non -
Latino29JUL2020
C4591001 1007
1007109538 Male 185.5 98.6 28.7 White Non-Hispanic/non -
Latino30JUL2020
C4591001 1007
1007109634 Female 165 84.9 31.2 White Non-Hispanic/non -
Latino30JUL2020
C4591001 1007
1007109749 Female 172 100.5 34 White Non-Hispanic/non -
Latino30JUL2020
C4591001 1007
1007110052 Female 164 66.1 24.6 White Non-Hispanic/non -
Latino30JUL2020
C4591001 1007
1007110254 Female 156 97.8 40.2 White Non-Hispanic/non -
Latino30JUL2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 49
FDA-CBER-2021-5683-0029280
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1007
1007110648 Female 167 90.5 32.5 White Non-Hispanic/non -
Latino03AUG2020
C4591001 1007
1007110741 Female 155.5 46.9 19.4 Asian Non-Hispanic/non -
Latino03AUG2020
C4591001 1007
1007110853 Male 177 115.5 36.9 Black or African American Non-Hispanic/non -
Latino03AUG2020
C4591001 1007
1007110936 Male 189.5 86.7 24.1 White Non-Hispanic/non -
Latino03AUG2020
C4591001 1007
1007111034 Male 174.5 84.6 27.8 Black or African American Hispanic/Latino 03AUG2020
C4591001 1007
1007111144 Female 166.2 64.9 23.5 American Indian or Alaska
native Hispanic/Latino 03AUG2020
C4591001 1007
1007111233 Male 181 100.3 30.6 Black or African American Non-Hispanic/non -
Latino03AUG2020
C4591001 1007
1007111745 Female 173 90.4 30.2 White Non-Hispanic/non -
Latino03AUG2020
C4591001 1007
1007111827 Female 165.8 68.9 25.1 White Non-Hispanic/non -
Latino03AUG2020
C4591001 1007
1007111935 Male 189 86.6 24.2 White Non-Hispanic/non -
Latino05AUG2020
C4591001 1007
1007112324 Female 166 58.3 21.2 White Hispanic/Latino 05AUG2020
C4591001 1007
1007112553 Male 172.7 96.9 32.5 White Non-Hispanic/non -
Latino05AUG2020
C4591001 1007
1007112954 Male 179.5 79.1 24.5 White Non-Hispanic/non -
Latino05AUG2020
C4591001 1007
1007113036 Male 174 91.1 30.1 Not reported Hispanic/Latino 05AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 50
FDA-CBER-2021-5683-0029281
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1007
1007113125 Male 183 74.5 22.2 Not reported Hispanic/Latino 05AUG2020
C4591001 1007
1007113242 Male 173 76 25.4 Asian Non-Hispanic/non -
Latino05AUG2020
C4591001 1007
1007113342 Male 178 97 30.6 White Non-Hispanic/non -
Latino05AUG2020
C4591001 1007
1007113745 Male 189 118.3 33.1 White Non-Hispanic/non -
Latino06AUG2020
C4591001 1007
1007113836 Female 172 78.8 26.6 White Non-Hispanic/non -
Latino06AUG2020
C4591001 1007
1007114355 Female 154.3 74.1 31.1 White Non-Hispanic/non -
Latino06AUG2020
C4591001 1007
1007114542 Female 163.5 57.2 21.4 White Non-Hispanic/non -
Latino06AUG2020
C4591001 1007
1007114626 Female 177.8 56.4 17.8 Not reported Non-Hispanic/non -
Latino06AUG2020
C4591001 1007
1007114843 Female 161 90.2 34.8 White Non-Hispanic/non -
Latino06AUG2020
C4591001 1007
1007115036 Male 188.5 107.7 30.3 Black or African American Non-Hispanic/non -
Latino10AUG2020
C4591001 1007
1007115154 Female 152.5 117.4 50.5 Black or African American Non-Hispanic/non -
Latino10AUG2020
C4591001 1007
1007115246 Female 159 51.2 20.3 White Hispanic/Latino 10AUG2020
C4591001 1007
1007115338 Female 172.5 108.1 36.3 Black or African American Non-Hispanic/non -
Latino10AUG2020
C4591001 1007
1007115422 Female 165 112.2 41.2 White Non-Hispanic/non -
Latino10AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 51
FDA-CBER-2021-5683-0029282
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1007
1007115539 Female 174 73.5 24.3 White Hispanic/Latino 10AUG2020
C4591001 1007
1007115732 Female 160 52.9 20.7 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1007
1007115838 Male 185.2 126 36.7 Black or African American Non-Hispanic/non -
Latino10AUG2020
C4591001 1007
1007115948 Female 165 125.3 46 Black or African American Non-Hispanic/non -
Latino10AUG2020
C4591001 1007
1007116240 Female 167.7 97.8 34.8 Black or African American Non-Hispanic/non -
Latino10AUG2020
C4591001 1007
1007117140 Female 162.3 63.9 24.3 Black or African American Non-Hispanic/non -
Latino12AUG2020
C4591001 1007
1007117235 Male 171 89.5 30.6 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1007
1007117546 Female 165.5 51 18.6 White Hispanic/Latino 12AUG2020
C4591001 1007
1007117839 Female 166.5 53.5 19.3 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1007
1007117939 Female 171 92.7 31.7 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1007
1007118142 Male 193 94.5 25.4 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1007
1007118453 Male 177 85.6 27.3 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1007
1007118555 Female 154.5 74.1 31 Asian Non-Hispanic/non -
Latino13AUG2020
C4591001 1007
1007118649 Female 166 82 29.8 Black or African American Non-Hispanic/non -
Latino13AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 52
FDA-CBER-2021-5683-0029283
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1007
1007119348 Female 160.3 68.3 26.6 White Hispanic/Latino 13AUG2020
C4591001 1007
1007119453 Female 173.5 83 27.6 Not reported Non-Hispanic/non -
Latino13AUG2020
C4591001 1007
1007119549 Female 160.5 105.5 41 White Hispanic/Latino 13AUG2020
C4591001 1007
1007119644 Female 170 128.1 44.3 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1007
1007119734 Female 156 48.9 20.1 Not reported Non-Hispanic/non -
Latino13AUG2020
C4591001 1007
1007120339 Female 158 50.3 20.1 Asian Non-Hispanic/non -
Latino17AUG2020
C4591001 1007
1007120442 Female 165.5 126.5 46.2 Black or African American Non-Hispanic/non -
Latino17AUG2020
C4591001 1007
1007120650 Female 167 108.8 39 Black or African American Non-Hispanic/non -
Latino17AUG2020
C4591001 1007
1007120736 Male 179 88.2 27.5 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1007
1007120838 Female 171 59 20.2 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1007
1007121150 Female 182 101.3 30.6 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1007
1007121238 Male 168 67.5 23.9 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1007
1007121451 Male 174.7 82.5 27 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1007
1007121749 Female 160.9 74.6 28.8 White Non-Hispanic/non -
Latino19AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 53
FDA-CBER-2021-5683-0029284
16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1007
1007121844 Male 186 81.1 23.4 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1007
1007121943 Female 170.5 68.3 23.5 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1007
1007122140 Female 155 50.2 20.9 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1007
1007122555 Male 186 86.2 24.9 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1007
1007122731 Male 183.5 79.5 23.6 Asian Non-Hispanic/non -
Latino19AUG2020
C4591001 1007
1007122839 Male 167 66.2 23.7 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1007
1007122949 Female 167 75.2 27 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1007
1007123048 Female 170 88.9 30.8 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1007
1007123135 Male 180.2 70.6 21.7 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1007
1007123232 Female 160 56.4 22 Asian Non-Hispanic/non -
Latino20AUG2020
C4591001 1007
1007123349 Female 163.5 86.3 32.3 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1007
1007123541 Female 174.2 83.6 27.5 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1007
1007123626 Female 172 108.8 36.8 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1007
1007123847 Female 151 70.4 30.9 White Non-Hispanic/non -
Latino20AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1007
1007124044 Female 169 124 43.4 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1007
1007124333 Female 166.4 75.1 27.1 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1007
1007124630 Female 160 72.9 28.5 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1007
1007125042 Female 164.5 95.7 35.4 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1007
1007125146 Male 167 61.5 22.1 Asian Non-Hispanic/non -
Latino24AUG2020
C4591001 1007
1007125245 Female 167 68.9 24.7 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1007
1007125339 Female 167 105.8 37.9 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1007
1007125641 Female 158 57.7 23.1 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1007
1007125851 Male 184 148.7 43.9 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1007
1007126448 Female 170 80.3 27.8 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1007
1007126641 Female 158.5 72.6 28.9 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1007
1007126927 Female 167 56.2 20.2 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1007
1007127042 Male 180 74 22.8 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1007
1007127235 Female 155 70.4 29.3 White Non-Hispanic/non -
Latino26AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1007
1007127528 Female 162 57.4 21.9 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1007
1007127643 Male 187 91.4 26.1 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1007
1007127841 Female 178 90.2 28.5 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1007
1007128038 Female 174 75.4 24.9 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1007
1007128129 Female 162 63.9 24.3 White Hispanic/Latino 27AUG2020
C4591001 1007
1007128444 Male 182 77.1 23.3 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1007
1007128551 Male 166.8 53 19 Asian Non-Hispanic/non -
Latino27AUG2020
C4591001 1007
1007128640 Female 163 54 20.3 Asian Non-Hispanic/non -
Latino27AUG2020
C4591001 1007
1007128925 Female 165.3 81.3 29.8 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1007
1007129547 Male 185 91.8 26.8 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1007
1007129650 Female 167.9 73.8 26.2 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1007
1007130753 Male 190 92.7 25.7 White Non-Hispanic/non -
Latino12OCT2020
C4591001 1007
1007130953 Male 176.5 135.6 43.5 White Non-Hispanic/non -
Latino12OCT2020
C4591001 1007
1007133449 Male 186 112.9 32.6 White Non-Hispanic/non -
Latino14OCT2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1007
1007133751 Female 178 78.2 24.7 White Non-Hispanic/non -
Latino14OCT2020
C4591001 1007
1007133952 Male 175 73.6 24 White Non-Hispanic/non -
Latino14OCT2020
C4591001 1007
1007134043 Male 187 96.4 27.6 Asian Non-Hispanic/non -
Latino14OCT2020
C4591001 1007
1007134116 Female 178 73.3 23.1 White Non-Hispanic/non -
Latino14OCT2020
C4591001 1007
1007134254 Male 182 106.5 32.2 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1007
1007135053 Male 172 81.8 27.7 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1007
1007135251 Female 149.9 78.1 34.8 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1007
1007135316 Female 160 66.3 25.9 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1007
1007135851 Female 158 54.1 21.7 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1007
1007136239 Female 158 61.7 24.7 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1007
1007136347 Male 186 81.6 23.6 Black or African American Non-Hispanic/non -
Latino19OCT2020
C4591001 1007
1007136536 Male 184.5 125 36.7 Black or African American Non-Hispanic/non -
Latino19OCT2020
C4591001 1007
1007136635 Male 185 92 26.9 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1007
1007136742 Male 168.5 74.5 26.2 Asian Non-Hispanic/non -
Latino19OCT2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1007
1007136843 Male 171 113.5 38.8 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1007
1007136936 Female 166 59.4 21.6 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1007
1007137030 Male 188 101.3 28.7 Native Hawaiian or other
Pacific IslanderNon-Hispanic/non -
Latino20OCT2020
C4591001 1007
1007137347 Male 173.5 85.7 28.5 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1007
1007137430 Female 172 79.5 26.9 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1007
1007137651 Female 157.5 78 31.4 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1007
1007137745 Male 166 69.2 25.1 Asian Non-Hispanic/non -
Latino20OCT2020
C4591001 1007
1007137824 Female 166 69.5 25.2 Asian Non-Hispanic/non -
Latino20OCT2020
C4591001 1007
1007138030 Female 162 74.5 28.4 Black or African American Non-Hispanic/non -
Latino20OCT2020
C4591001 1007
1007138139 Male 183 91.8 27.4 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1007
1007138245 Male 166 67.1 24.4 Native Hawaiian or other
Pacific IslanderHispanic/Latino 20OCT2020
C4591001 1007
1007138516 Male 177 66.1 21.1 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1007
1007138648 Female 167.5 92.5 33 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1007
1007138742 Male 186 100.3 29 White Non-Hispanic/non -
Latino21OCT2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1007
1007138831 Male 191 95.4 26.2 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1007
1007138927 Male 175.5 86.8 28.2 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1007
1007139038 Male 173.5 80.9 26.9 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1007
1007139117 Female 163 51.4 19.3 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1007
1007139245 Female 162.5 63.9 24.2 Asian Non-Hispanic/non -
Latino21OCT2020
C4591001 1007
1007139741 Female 164.5 65 24 Asian Non-Hispanic/non -
Latino21OCT2020
C4591001 1007
1007139817 Male 178.5 67.9 21.3 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1007
1007139923 Female 155 71.3 29.7 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1007
1007140017 Male 180 55.7 17.2 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1007
1007140138 Male 188 169.1 47.8 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1007
1007140254 Male 191.5 96.8 26.4 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1007
1007140316 Male 180.5 60.1 18.4 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1007
1007140416 Male 173.5 65.7 21.8 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1007
1007140540 Male 183.4 99.4 29.6 White Non-Hispanic/non -
Latino22OCT2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1007
1007140652 Female 163 69 26 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1007
1007140741 Male 186 99.1 28.6 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1007
1007140820 Female 169.5 71.8 25 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1007
1007141037 Female 168.2 71.6 25.3 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1007
1007141626 Female 158 70 28 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1007
1007141849 Female 161 78.6 30.3 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1007
1007141944 Female 160 74.5 29.1 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1007
1007142045 Male 170.5 75 25.8 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1007
1007142151 Female 163 70.4 26.5 Black or African American Non-Hispanic/non -
Latino22OCT2020
C4591001 1007
1007142219 Female 158 46.4 18.6 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1007
1007142316 Female 164.5 59 21.8 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1007
1007142419 Female 167 61.8 22.2 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1007
1007142550 Female 166 80 29 Black or African American Non-Hispanic/non -
Latino22OCT2020
C4591001 1007
1007142647 Male 167.4 84.1 30 Asian Non-Hispanic/non -
Latino22OCT2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1007
1007142732 Male 174.5 69.1 22.7 White Hispanic/Latino 22OCT2020
C4591001 1007
1007143117 Male 180 62.2 19.2 White Non-Hispanic/non -
Latino26OCT2020
C4591001 1007
1007143317 Male 182.9 82 24.5 White Non-Hispanic/non -
Latino27OCT2020
C4591001 1007
1007143416 Female 161 56.6 21.8 White Non-Hispanic/non -
Latino27OCT2020
C4591001 1007
1007143516 Male 181 71.3 21.8 White Non-Hispanic/non -
Latino28OCT2020
C4591001 1007
1007143617 Female 172 71.4 24.1 White Non-Hispanic/non -
Latino28OCT2020
C4591001 1007
1007143836 Female 155 60.2 25.1 White Non-Hispanic/non -
Latino29OCT2020
C4591001 1007
1007143917 Female 160 70.3 27.5 White Non-Hispanic/non -
Latino29OCT2020
C4591001 1007
1007144049 Male 199 101.7 25.7 Black or African American Non-Hispanic/non -
Latino29OCT2020
C4591001 1007
1007144122 Female 166 71.7 26 White Non-Hispanic/non -
Latino29OCT2020
C4591001 1007
1007144216 Female 173 44.8 15 White Non-Hispanic/non -
Latino03NOV2020
C4591001 1007
1007144317 Female 161 53.2 20.5 White Non-Hispanic/non -
Latino04NOV2020
C4591001 1007
1007144417 Female 164.5 59.7 22.1 White Non-Hispanic/non -
Latino04NOV2020
C4591001 1007
1007144517 Male 187 115.5 33 White Non-Hispanic/non -
Latino10NOV2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1007
1007144716 Male 187.5 73.3 20.8 White Non-Hispanic/non -
Latino11NOV2020
C4591001 1007
1007144816 Male 168 58.3 20.7 White Hispanic/Latino 11NOV2020
C4591001 1007
1007144917 Female 162.5 57.2 21.7 White Non-Hispanic/non -
Latino11NOV2020
C4591001 1007
1007145016 Female 164 58.6 21.8 White Non-Hispanic/non -
Latino12NOV2020
C4591001 1007
1007145117 Male 174.5 64.6 21.2 White Non-Hispanic/non -
Latino12NOV2020
C4591001 1007
1007145216 Male 177.5 63 20 White Non-Hispanic/non -
Latino12NOV2020
C4591001 1007
1007145417 Female 168 58.2 20.6 White Non-Hispanic/non -
Latino12NOV2020
C4591001 1007
1007145517 Female 167.5 98.8 35.2 White Non-Hispanic/non -
Latino12NOV2020
C4591001 1008
1008100626 Male 184.15 98.82 29.1 Black or African American Non-Hispanic/non -
Latino10AUG2020
C4591001 1008
1008100745 Female171.45 84.91 28.8 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1008
1008101155 Female 165.1 68.73 25.2 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1008
1008101354 Male 172.72 106.73 35.7 White Hispanic/Latino 11AUG2020
C4591001 1008
1008101533 Male 187.96 71.45 20.2 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1008
1008101836 Male 182.25 105.45 31.7 White Non-Hispanic/non -
Latino12AUG2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008101931 Female171.45 70.18 23.8 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1008
1008102239 Male 184.15 85.18 25.1 Asian Non-Hispanic/non -
Latino12AUG2020
C4591001 1008
1008102448 Female168.91 84.27 29.5 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1008
1008102550 Male 181.61 132 39.9 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1008
1008102853 Female151.13 58.45 25.5 Asian Non-Hispanic/non -
Latino13AUG2020
C4591001 1008
1008102937 Female170.18 100 34.5 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1008
1008103045 Female163.83 82.27 30.6 Asian Non-Hispanic/non -
Latino13AUG2020
C4591001 1008
1008103136 Male 190.5 72.82 20 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1008
1008103252 Male 172.72 99.64 33.3 Black or African American Non-Hispanic/non -
Latino13AUG2020
C4591001 1008
1008103354 Female161.29 100.18 38.4 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1008
1008103650 Female162.56 66.18 25 White Hispanic/Latino 14AUG2020
C4591001 1008
1008103738 Female166.37 71.18 25.7 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1008
1008104055 Male 179.71 80 24.7 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1008
1008104232 Male 181.61 73.09 22.1 White Hispanic/Latino 17AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008104354 Female162.56 62.73 23.7 White Hispanic/Latino 17AUG2020
C4591001 1008
1008104639 Female179.07 63.09 19.6 White Hispanic/Latino 17AUG2020
C4591001 1008
1008104728 Female172.72 149.73 50.1 White Hispanic/Latino 17AUG2020
C4591001 1008
1008104838 Female160.02 147.09 57.3 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1008
1008104953 Female160.02 137.45 53.6 Black or African American Non-Hispanic/non -
Latino17AUG2020
C4591001 1008
1008105149 Male 190.5 84.36 23.2 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1008
1008105254 Female176.53 100 32 White Hispanic/Latino 18AUG2020
C4591001 1008
1008105329 Male 182.88 82.36 24.6 Asian Non-Hispanic/non -
Latino18AUG2020
C4591001 1008
1008105447 Female163.83 57.09 21.2 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1008
1008105953 Female175.26 81.45 26.5 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1008
1008106451 Male 182.88 120.64 36 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1008
1008106545 Female 165.1 75.18 27.5 Black or African American Non-Hispanic/non -
Latino19AUG2020
C4591001 1008
1008106650 Male 181.61 100.82 30.5 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1008
1008106727 Female172.72 73.27 24.5 White Non-Hispanic/non -
Latino19AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008106853 Male 180.34 83 25.5 Asian Non-Hispanic/non -
Latino20AUG2020
C4591001 1008
1008107138 Female 177.8 123.27 38.9 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1008
1008107246 Male 181.61 97 29.3 Black or African American Non-Hispanic/non -
Latino20AUG2020
C4591001 1008
1008107739 Male 190.5 112.45 30.9 White Hispanic/Latino 21AUG2020
C4591001 1008
1008107846 Female162.56 103.64 39.1 Black or African American Non-Hispanic/non -
Latino21AUG2020
C4591001 1008
1008107940 Male 166.37 72.64 26.2 Asian Non-Hispanic/non -
Latino21AUG2020
C4591001 1008
1008108035 Female167.64 72.27 25.7 White Non-Hispanic/non -
Latino21AUG2020
C4591001 1008
1008108654 Female167.64 99.91 35.5 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1008
1008108753 Female154.94 68.82 28.6 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1008
1008108842 Female170.18 70.55 24.3 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1008
1008108944 Male 179.07 101.45 31.6 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1008
1008109140 Male 179.71 93.09 28.8 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1008
1008109536 Female171.45 76.82 26.1 Black or African American Non-Hispanic/non -
Latino25AUG2020
C4591001 1008
1008109954 Female168.91 132.55 46.4 White Non-Hispanic/non -
Latino25AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008110150 Female 165.1 74.45 27.3 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1008
1008110246 Female166.37 100.55 36.2 Black or African American Non-Hispanic/non -
Latino26AUG2020
C4591001 1008
1008110335 Female166.37 97.91 35.3 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1008
1008111346 Male 196.85 98.36 25.3 Black or African American Non-Hispanic/non -
Latino26AUG2020
C4591001 1008
1008111640 Male 184.15 129.09 38 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1008
1008112153 Male 176.53 128.55 41.2 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1008
1008112253 Male 189.23 98.27 27.4 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1008
1008112939 Male 175.9 91.27 29.4 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1008
1008113052 Female161.93 90 34.2 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1008
1008113640 Male 185.42 104.09 30.2 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1008
1008113737 Male 181.61 75.18 22.7 Asian Non-Hispanic/non -
Latino28AUG2020
C4591001 1008
1008113842 Female 165.1 99.64 36.5 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1008
1008114040 Female154.94 90.82 37.7 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1008
1008114251 Male 185.42 73.73 21.4 Asian Non-Hispanic/non -
Latino28AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008114331 Male 176.53 91 29.1 Asian Non-Hispanic/non -
Latino28AUG2020
C4591001 1008
1008114737 Female163.83 94 34.9 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1008
1008114843 Male 170.18 75.91 26.2 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1008
1008114940 Male 180.98 98.73 30.1 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1008
1008115044 Male 175.26 82.64 26.8 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1008
1008115140 Female 152.4 88.36 38 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1008
1008115241 Male 189.23 103.73 28.9 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1008
1008115331 Female162.56 78.64 29.7 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1008
1008115521 Female162.56 98.91 37.3 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1008
1008115645 Female173.99 113.55 37.4 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1008
1008115833 Female 165.1 58.64 21.5 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1008
1008115945 Male 172.72 93.82 31.4 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1008
1008116023 Female175.26 78.09 25.4 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1008
1008116643 Male 167.64 69.55 24.7 White Non-Hispanic/non -
Latino02SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008118333 Female170.18 92 31.7 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1008
1008118750 Female172.72 100.55 33.6 American Indian or Alaska
native Non-Hispanic/non -
Latino03SEP2020
C4591001 1008
1008119124 Male 177.8 80.09 25.3 White Non-Hispanic/non -
Latino04SEP2020
C4591001 1008
1008119328 Female162.56 63.73 24.1 White Non-Hispanic/non -
Latino04SEP2020
C4591001 1008
1008119430 Male 181.61 77 23.3 White Non-Hispanic/non -
Latino04SEP2020
C4591001 1008
1008119738 Female 177.8 76.27 24.1 White Non-Hispanic/non -
Latino04SEP2020
C4591001 1008
1008119846 Female163.83 76.18 28.3 White Hispanic/Latino 04SEP2020
C4591001 1008
1008119944 Male 182.88 104.18 31.1 White Non-Hispanic/non -
Latino04SEP2020
C4591001 1008
1008120051 Female172.72 86.27 28.9 White Non-Hispanic/non -
Latino04SEP2020
C4591001 1008
1008120242 Male 182.88 83.64 25 White Non-Hispanic/non -
Latino04SEP2020
C4591001 1008
1008121253 Female157.48 111.82 45 White Non-Hispanic/non -
Latino08SEP2020
C4591001 1008
1008121552 Female166.37 64.91 23.4 White Hispanic/Latino 08SEP2020
C4591001 1008
1008121734 Male 185.42 90.73 26.3 White Non-Hispanic/non -
Latino08SEP2020
C4591001 1008
1008121842 Female173.99 104.18 34.3 White Non-Hispanic/non -
Latino08SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008122054 Female170.82 94.64 32.4 White Non-Hispanic/non -
Latino08SEP2020
C4591001 1008
1008122144 Male 164.47 77.55 28.6 Asian Non-Hispanic/non -
Latino08SEP2020
C4591001 1008
1008122452 Female151.77 65.45 28.4 Asian Non-Hispanic/non -
Latino08SEP2020
C4591001 1008
1008122539 Male 182.88 99.36 29.6 White Non-Hispanic/non -
Latino08SEP2020
C4591001 1008
1008123253 Female175.26 83.68 27.2 White Non-Hispanic/non -
Latino08SEP2020
C4591001 1008
1008123338 Female172.72 104.64 35 White Hispanic/Latino 08SEP2020
C4591001 1008
1008123445 Male 182.88 131 39.1 White Hispanic/Latino 08SEP2020
C4591001 1008
1008123545 Female162.56 107.73 40.7 White Hispanic/Latino 08SEP2020
C4591001 1008
1008123831 Female162.56 92 34.7 White Non-Hispanic/non -
Latino09SEP2020
C4591001 1008
1008123934 Female167.64 91.27 32.4 White Non-Hispanic/non -
Latino09SEP2020
C4591001 1008
1008124040 Male 180.34 103.09 31.6 White Non-Hispanic/non -
Latino09SEP2020
C4591001 1008
1008124440 Female182.88 71.82 21.4 White Non-Hispanic/non -
Latino09SEP2020
C4591001 1008
1008125154 Male 186.69 102.27 29.3 White Non-Hispanic/non -
Latino09SEP2020
C4591001 1008
1008125341 Male 173.99 81.64 26.9 Asian Non-Hispanic/non -
Latino09SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 69
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008125640 Male 171.45 83.45 28.3 White Not reported 09SEP2020
C4591001 1008
1008125735 Male 185.42 84.18 24.4 White Non-Hispanic/non -
Latino09SEP2020
C4591001 1008
1008125844 Female168.91 74.55 26.1 White Non-Hispanic/non -
Latino09SEP2020
C4591001 1008
1008126046 Female 165.1 101 37 Black or African American Non-Hispanic/non -
Latino09SEP2020
C4591001 1008
1008126136 Female170.18 63.27 21.8 White Non-Hispanic/non -
Latino09SEP2020
C4591001 1008
1008126326 Female170.18 79 27.2 White Non-Hispanic/non -
Latino09SEP2020
C4591001 1008
1008126533 Female179.71 109.91 34 White Non-Hispanic/non -
Latino10SEP2020
C4591001 1008
1008127153 Male 172.72 75.73 25.3 White Non-Hispanic/non -
Latino10SEP2020
C4591001 1008
1008127446 Male 187.96 98.64 27.9 White Non-Hispanic/non -
Latino10SEP2020
C4591001 1008
1008128120 Female157.48 73.36 29.5 Black or African American Non-Hispanic/non -
Latino10SEP2020
C4591001 1008
1008128653 Female153.67 59.18 25 Asian Non-Hispanic/non -
Latino10SEP2020
C4591001 1008
1008128937 Male 181.61 117.18 35.5 White Hispanic/Latino 10SEP2020
C4591001 1008
1008129024 Female154.94 58.55 24.3 Asian Non-Hispanic/non -
Latino11SEP2020
C4591001 1008
1008129238 Male 184.15 141.18 41.5 White Non-Hispanic/non -
Latino11SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008129338 Female175.26 105.91 34.4 White Non-Hispanic/non -
Latino11SEP2020
C4591001 1008
1008129528 Male 182.88 91.82 27.4 White Non-Hispanic/non -
Latino11SEP2020
C4591001 1008
1008129748 Female 165.1 98.27 36 White Non-Hispanic/non -
Latino11SEP2020
C4591001 1008
1008130028 Female160.02 82.32 32.1 Black or African American Non-Hispanic/non -
Latino11SEP2020
C4591001 1008
1008130439 Female158.75 60.36 23.9 White Non-Hispanic/non -
Latino11SEP2020
C4591001 1008
1008130649 Female160.02 67.45 26.3 White Non-Hispanic/non -
Latino11SEP2020
C4591001 1008
1008131025 Male 180.34 65.73 20.2 White Non-Hispanic/non -
Latino14SEP2020
C4591001 1008
1008131247 Male 193.04 90.82 24.3 White Non-Hispanic/non -
Latino14SEP2020
C4591001 1008
1008131328 Male 182.88 83 24.8 White Non-Hispanic/non -
Latino14SEP2020
C4591001 1008
1008131452 Female167.64 78.18 27.8 White Non-Hispanic/non -
Latino14SEP2020
C4591001 1008
1008131539 Male 187.96 113 31.9 White Non-Hispanic/non -
Latino14SEP2020
C4591001 1008
1008131637 Female173.99 71.09 23.4 White Non-Hispanic/non -
Latino14SEP2020
C4591001 1008
1008132040 Female167.64 64 22.7 White Non-Hispanic/non -
Latino14SEP2020
C4591001 1008
1008132135 Female163.83 99.55 37 White Non-Hispanic/non -
Latino14SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 71
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008132555 Male 171.45 91.73 31.1 White Non-Hispanic/non -
Latino14SEP2020
C4591001 1008
1008132655 Female168.91 76 26.6 White Non-Hispanic/non -
Latino14SEP2020
C4591001 1008
1008132731 Male 175.26 104.09 33.8 White Non-Hispanic/non -
Latino14SEP2020
C4591001 1008
1008132836 Male 176.53 76.45 24.5 White Non-Hispanic/non -
Latino14SEP2020
C4591001 1008
1008133322 Male 182.88 108.64 32.4 White Non-Hispanic/non -
Latino15SEP2020
C4591001 1008
1008133642 Male 162.56 63.09 23.8 White Non-Hispanic/non -
Latino15SEP2020
C4591001 1008
1008133739 Female162.56 79.36 30 White Non-Hispanic/non -
Latino15SEP2020
C4591001 1008
1008133853 Male 168.91 69.45 24.3 White Non-Hispanic/non -
Latino15SEP2020
C4591001 1008
1008134132 Male 175.26 92.91 30.2 White Non-Hispanic/non -
Latino15SEP2020
C4591001 1008
1008134345 Male 190.5 129.91 35.7 White Non-Hispanic/non -
Latino15SEP2020
C4591001 1008
1008134445 Female163.83 58.73 21.8 White Non-Hispanic/non -
Latino15SEP2020
C4591001 1008
1008134653 Male 179.07 67.45 21 Asian Non-Hispanic/non -
Latino15SEP2020
C4591001 1008
1008134755 Female153.67 48.73 20.6 Asian Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008134834 Male 195.58 111.64 29.1 White Non-Hispanic/non -
Latino16SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008134941 Male 183.52 92.27 27.3 White Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008135039 Female175.26 115.64 37.6 White Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008135143 Female181.61 71.18 21.5 White Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008135236 Male 179.07 88.91 27.7 White Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008135453 Female159.39 70.55 27.7 White Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008135749 Male 176.53 96.09 30.8 White Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008135835 Female179.07 101.64 31.6 White Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008135951 Female 165.1 79.27 29 White Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008136029 Female167.64 45.45 16.1 White Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008136138 Male 187.96 113.09 31.9 White Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008136435 Female171.45 94 31.9 White Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008136521 Female 152.4 50 21.5 White Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008136650 Male 187.96 115.27 32.6 White Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008136741 Male 180.34 99.27 30.5 White Non-Hispanic/non -
Latino16SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008136848 Male 170.18 90.45 31.2 White Non-Hispanic/non -
Latino16SEP2020
C4591001 1008
1008137055 Male 173.99 72.55 23.9 Asian Non-Hispanic/non -
Latino17SEP2020
C4591001 1008
1008137248 Male 165.1 91.36 33.4 White Non-Hispanic/non -
Latino17SEP2020
C4591001 1008
1008137447 Female 165.1 56.55 20.7 White Non-Hispanic/non -
Latino17SEP2020
C4591001 1008
1008137949 Male 181.61 89.73 27.1 White Non-Hispanic/non -
Latino17SEP2020
C4591001 1008
1008138237 Male 189.23 102.64 28.6 White Non-Hispanic/non -
Latino17SEP2020
C4591001 1008
1008138326 Male 182.88 81.55 24.3 White Non-Hispanic/non -
Latino17SEP2020
C4591001 1008
1008138452 Female168.91 65.27 22.8 White Non-Hispanic/non -
Latino17SEP2020
C4591001 1008
1008138534 Male 177.8 87.09 27.5 Asian Non-Hispanic/non -
Latino17SEP2020
C4591001 1008
1008138836 Male 184.15 97.18 28.6 White Hispanic/Latino 17SEP2020
C4591001 1008
1008139145 Female167.64 134.36 47.7 White Non-Hispanic/non -
Latino17SEP2020
C4591001 1008
1008139243 Male 180.34 90.82 27.9 White Non-Hispanic/non -
Latino18SEP2020
C4591001 1008
1008139346 Male 184.15 73.91 21.7 White Non-Hispanic/non -
Latino18SEP2020
C4591001 1008
1008139433 Male 180.34 89.09 27.3 White Non-Hispanic/non -
Latino18SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008139542 Male 181.61 105.73 32 White Non-Hispanic/non -
Latino18SEP2020
C4591001 1008
1008139634 Female164.47 89.82 33.1 White Hispanic/Latino 18SEP2020
C4591001 1008
1008139739 Female157.48 85.18 34.3 White Non-Hispanic/non -
Latino18SEP2020
C4591001 1008
1008139854 Female160.02 73.45 28.6 White Non-Hispanic/non -
Latino18SEP2020
C4591001 1008
1008140136 Female170.18 87.55 30.2 White Non-Hispanic/non -
Latino18SEP2020
C4591001 1008
1008140251 Female168.28 126.18 44.5 Asian Non-Hispanic/non -
Latino18SEP2020
C4591001 1008
1008140445 Female 152.4 56 24.1 White Non-Hispanic/non -
Latino18SEP2020
C4591001 1008
1008140742 Male 190.5 204.55 56.2 White Non-Hispanic/non -
Latino18SEP2020
C4591001 1008
1008140842 Male 185.42 111.73 32.4 White Non-Hispanic/non -
Latino18SEP2020
C4591001 1008
1008141026 Female162.56 115.18 43.5 White Non-Hispanic/non -
Latino18SEP2020
C4591001 1008
1008141138 Male 191.77 104 28.2 White Non-Hispanic/non -
Latino18SEP2020
C4591001 1008
1008141350 Male 185.42 96.09 27.9 White Non-Hispanic/non -
Latino18SEP2020
C4591001 1008
1008141649 Male 193.04 95.45 25.6 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008141835 Male 161.29 51.73 19.8 Asian Non-Hispanic/non -
Latino21SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 75
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008141924 Male 189.23 198.18 55.2 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008142025 Female167.01 70.36 25.2 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008142153 Female168.91 86.91 30.4 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008142252 Female182.88 72 21.5 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008142332 Male 168.91 93.73 32.8 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008142546 Male 171.45 63.55 21.6 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008142638 Female162.56 92.82 35 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008142736 Female171.45 54.64 18.5 Asian Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008142928 Female170.18 53.91 18.6 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008143041 Male 185.42 146.09 42.4 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008143238 Male 191.77 83.82 22.7 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008143345 Female168.28 68.73 24.2 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008143520 Male 186.06 105.64 30.4 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008143639 Male 187.96 85.91 24.3 White Non-Hispanic/non -
Latino21SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 76
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008143753 Female167.01 83 29.7 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008143854 Female171.45 73.86 25.1 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008143951 Male 174.63 93.45 30.6 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008144051 Female172.72 85.55 28.6 Black or African American Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008144130 Female162.56 76.64 28.9 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1008
1008144233 Male 175.26 125.64 40.8 White Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008144422 Female161.29 56.09 21.5 Asian Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008144728 Male 174.63 93.09 30.5 White Hispanic/Latino 22SEP2020
C4591001 1008
1008144935 Male 166.37 80.18 28.9 White Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008145039 Male 170.18 80.18 27.6 White Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008145232 Female172.72 62.36 20.9 Asian Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008145350 Female161.29 65.64 25.2 White Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008145647 Female 165.1 81.09 29.7 White Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008145735 Male 171.45 88.09 29.9 White Hispanic/Latino 22SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 77
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008146239 Male 184.15 78.36 23.1 White Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008146352 Female156.21 63.73 26.1 White Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008146455 Male 176.53 74.09 23.7 Asian Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008146648 Male 179.07 92.82 28.9 White Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008146745 Female170.18 57.82 19.9 White Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008146840 Male 180.34 128.09 39.3 White Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008146939 Male 161.93 58.64 22.3 White Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008147048 Male 181.61 109.64 33.2 White Non-Hispanic/non -
Latino22SEP2020
C4591001 1008
1008147152 Female163.83 72.27 26.9 White Hispanic/Latino 22SEP2020
C4591001 1008
1008147236 Male 196.85 82.09 21.1 White Non-Hispanic/non -
Latino23SEP2020
C4591001 1008
1008147347 Female170.18 63.45 21.9 White Non-Hispanic/non -
Latino23SEP2020
C4591001 1008
1008147439 Male 184.15 97.64 28.7 White Non-Hispanic/non -
Latino23SEP2020
C4591001 1008
1008147530 Female160.02 58.91 23 White Non-Hispanic/non -
Latino23SEP2020
C4591001 1008
1008147651 Female156.85 64.73 26.3 White Non-Hispanic/non -
Latino23SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 78
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008147741 Female 152.4 54.45 23.4 Asian Non-Hispanic/non -
Latino23SEP2020
C4591001 1008
1008147940 Female172.72 88.55 29.6 White Non-Hispanic/non -
Latino23SEP2020
C4591001 1008
1008148021 Male 190.5 90.18 24.8 White Non-Hispanic/non -
Latino23SEP2020
C4591001 1008
1008148152 Female 165.1 75.09 27.5 White Non-Hispanic/non -
Latino23SEP2020
C4591001 1008
1008148538 Female170.18 70.27 24.2 White Non-Hispanic/non -
Latino23SEP2020
C4591001 1008
1008148747 Male 193.04 100.27 26.8 Asian Non-Hispanic/non -
Latino23SEP2020
C4591001 1008
1008149230 Female171.45 140.73 47.8 White Non-Hispanic/non -
Latino23SEP2020
C4591001 1008
1008149319 Male 168.91 75.27 26.3 White Non-Hispanic/non -
Latino23SEP2020
C4591001 1008
1008149647 Female170.18 77.27 26.6 Black or African American Non-Hispanic/non -
Latino23SEP2020
C4591001 1008
1008149736 Female170.18 67.27 23.2 White Non-Hispanic/non -
Latino23SEP2020
C4591001 1008
1008149925 Male 182.88 79.09 23.6 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1008
1008150045 Female162.56 92 34.7 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1008
1008150454 Male 171.45 112.91 38.3 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1008
1008150544 Female170.18 88.65 30.5 White Non-Hispanic/non -
Latino24SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008150626 Male 181.61 76.64 23.2 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1008
1008150749 Male 182.88 86.09 25.7 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1008
1008150949 Male 161.93 62.91 23.9 Asian Non-Hispanic/non -
Latino24SEP2020
C4591001 1008
1008151232 Male 176.53 85.18 27.3 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1008
1008151332 Male 187.96 83.36 23.5 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1008
1008151435 Male 187.96 112.09 31.7 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1008
1008151830 Male 187.96 111.45 31.5 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1008
1008152055 Male 189.23 93 25.9 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1008
1008152130 Female162.56 56.27 21.2 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1008
1008152434 Female181.61 74.09 22.4 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1008
1008152543 Female157.48 62.73 25.2 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1008
1008152736 Male 175.26 76.27 24.8 White Non-Hispanic/non -
Latino25SEP2020
C4591001 1008
1008152854 Female158.12 67.73 27 White Non-Hispanic/non -
Latino25SEP2020
C4591001 1008
1008152938 Male 185.42 144.27 41.9 White Non-Hispanic/non -
Latino25SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008153245 Female166.37 90.82 32.7 White Non-Hispanic/non -
Latino25SEP2020
C4591001 1008
1008153347 Female171.45 127.91 43.4 White Non-Hispanic/non -
Latino25SEP2020
C4591001 1008
1008153449 Male 179.07 100.64 31.3 White Non-Hispanic/non -
Latino25SEP2020
C4591001 1008
1008154129 Male 182.88 93 27.7 White Non-Hispanic/non -
Latino25SEP2020
C4591001 1008
1008154248 Female 165.1 63.73 23.3 White Non-Hispanic/non -
Latino25SEP2020
C4591001 1008
1008154345 Female167.64 83.55 29.7 Black or African American Non-Hispanic/non -
Latino25SEP2020
C4591001 1008
1008154444 Female159.39 74.64 29.3 White Hispanic/Latino 25SEP2020
C4591001 1008
1008154745 Male 185.42 87.91 25.5 Black or African American Non-Hispanic/non -
Latino28SEP2020
C4591001 1008
1008154851 Female162.56 70.59 26.7 White Hispanic/Latino 28SEP2020
C4591001 1008
1008154939 Male 175.26 91.82 29.8 Black or African American Non-Hispanic/non -
Latino28SEP2020
C4591001 1008
1008155117 Female156.85 59.64 24.2 White Non-Hispanic/non -
Latino30SEP2020
C4591001 1008
1008155244 Male 175.26 193.32 62.8 Black or African American Non-Hispanic/non -
Latino30SEP2020
C4591001 1008
1008155316 Male 193.04 79.36 21.3 White Non-Hispanic/non -
Latino30SEP2020
C4591001 1008
1008155417 Male 167.64 59 20.9 White Non-Hispanic/non -
Latino30SEP2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008155544 Female 177.8 83.18 26.3 American Indian or Alaska
native Non-Hispanic/non -
Latino30SEP2020
C4591001 1008
1008155654 Female 165.1 138.82 50.8 Black or African American Non-Hispanic/non -
Latino01OCT2020
C4591001 1008
1008155735 Female154.31 85.45 35.8 White Hispanic/Latino 01OCT2020
C4591001 1008
1008155817 Female 163.2 71.36 26.7 Black or African American Non-Hispanic/non -
Latino02OCT2020
C4591001 1008
1008155916 Male 179.07 65.45 20.4 White Non-Hispanic/non -
Latino02OCT2020
C4591001 1008
1008156749 Female155.58 52.64 21.7 Asian Non-Hispanic/non -
Latino06OCT2020
C4591001 1008
1008156850 Female169.55 56.09 19.5 White Hispanic/Latino 06OCT2020
C4591001 1008
1008157240 Female172.72 77.18 25.8 White Non-Hispanic/non -
Latino07OCT2020
C4591001 1008
1008157342 Male 198.12 115.45 29.3 White Non-Hispanic/non -
Latino08OCT2020
C4591001 1008
1008157438 Female161.93 76.64 29.2 White Non-Hispanic/non -
Latino09OCT2020
C4591001 1008
1008157643 Male 171.45 77 26.1 White Non-Hispanic/non -
Latino09OCT2020
C4591001 1008
1008157719 Male 186.69 84.18 24.1 White Non-Hispanic/non -
Latino09OCT2020
C4591001 1008
1008157844 Female 165.1 61.45 22.5 White Non-Hispanic/non -
Latino09OCT2020
C4591001 1008
1008157948 Male 177.8 104.55 33 White Non-Hispanic/non -
Latino09OCT2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008158038 Male 167.64 110 39.1 White Non-Hispanic/non -
Latino09OCT2020
C4591001 1008
1008158148 Female162.56 63.09 23.8 White Non-Hispanic/non -
Latino09OCT2020
C4591001 1008
1008158254 Male 180.34 82.09 25.2 White Non-Hispanic/non -
Latino09OCT2020
C4591001 1008
1008158317 Male 180.34 66.18 20.3 White Non-Hispanic/non -
Latino09OCT2020
C4591001 1008
1008158453 Female163.83 90.73 33.7 Black or African American Non-Hispanic/non -
Latino12OCT2020
C4591001 1008
1008159037 Female175.26 90.18 29.3 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1008
1008159432 Female168.28 117.18 41.3 Black or African American Non-Hispanic/non -
Latino13OCT2020
C4591001 1008
1008159546 Male 182.88 98.91 29.5 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1008
1008159638 Female160.02 109.09 42.5 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1008
1008159817 Female167.64 57.82 20.5 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1008
1008160028 Female175.26 123.82 40.2 White Hispanic/Latino 14OCT2020
C4591001 1008
1008160438 Male 182.88 98.73 29.5 White Non-Hispanic/non -
Latino14OCT2020
C4591001 1008
1008160544 Female160.02 61 23.8 White Non-Hispanic/non -
Latino14OCT2020
C4591001 1008
1008160641 Male 177.17 82.91 26.4 White Non-Hispanic/non -
Latino14OCT2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008160721 Female160.02 71.36 27.8 White Non-Hispanic/non -
Latino14OCT2020
C4591001 1008
1008160844 Male 170.18 78.27 27 Asian Non-Hispanic/non -
Latino14OCT2020
C4591001 1008
1008161117 Male 180.34 58.64 18 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1008
1008161238 Female172.72 145 48.5 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1008
1008161754 Male 180.34 90.36 27.7 Black or African American Non-Hispanic/non -
Latino15OCT2020
C4591001 1008
1008161844 Male 176.53 99.55 31.9 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1008
1008162053 Female162.56 69.27 26.2 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1008
1008162328 Male 182.88 67.45 20.1 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1008
1008162848 Female160.02 57.45 22.4 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1008
1008162943 Male 168.28 81.91 28.9 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1008
1008163017 Male 168.28 77.55 27.3 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1008
1008163137 Male 195.58 123.27 32.2 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1008
1008163217 Male 185.42 80.64 23.4 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1008
1008163317 Female171.45 69.73 23.7 White Non-Hispanic/non -
Latino19OCT2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008163744 Male 170.18 97.09 33.5 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1008
1008163822 Male 179.07 105.18 32.7 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1008
1008164355 Male 177.8 84.09 26.5 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1008
1008164723 Female170.82 82.36 28.2 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1008
1008164844 Male 176.53 93.73 30 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1008
1008164950 Male 175.26 99.09 32.2 Black or African American Non-Hispanic/non -
Latino20OCT2020
C4591001 1008
1008165336 Female176.53 78.41 25.1 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1008
1008165453 Male 173.99 74.09 24.4 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1008
1008165541 Male 185.42 96.18 27.9 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1008
1008165750 Male 177.8 76.18 24 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1008
1008165917 Male 180.34 72.55 22.3 Not reported Non-Hispanic/non -
Latino21OCT2020
C4591001 1008
1008166354 Female167.01 68.82 24.6 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1008
1008166449 Female167.64 79.09 28.1 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1008
1008166524 Female158.12 56.73 22.6 White Non-Hispanic/non -
Latino22OCT2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008166843 Male 185.42 121.64 35.3 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1008
1008166955 Male 167.64 83.64 29.7 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1008
1008167047 Male 181.61 88.36 26.7 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1008
1008167245 Female170.18 51.09 17.6 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1008
1008167318 Male 173.36 68 22.6 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1008
1008167446 Female166.37 92.73 33.4 Black or African American Non-Hispanic/non -
Latino22OCT2020
C4591001 1008
1008167540 Male 180.34 79.73 24.5 White Non-Hispanic/non -
Latino23OCT2020
C4591001 1008
1008167647 Male 185.42 90.09 26.1 White Non-Hispanic/non -
Latino23OCT2020
C4591001 1008
1008167743 Female 177.8 93.27 29.4 White Non-Hispanic/non -
Latino23OCT2020
C4591001 1008
1008167817 Male 182.88 55.64 16.6 White Non-Hispanic/non -
Latino23OCT2020
C4591001 1008
1008168027 Male 179.07 57.55 17.9 White Non-Hispanic/non -
Latino23OCT2020
C4591001 1008
1008168246 Female 165.1 68.18 25 White Non-Hispanic/non -
Latino23OCT2020
C4591001 1008
1008168333 Female160.02 47.73 18.6 White Non-Hispanic/non -
Latino23OCT2020
C4591001 1008
1008168842 Female175.26 64.45 20.9 White Non-Hispanic/non -
Latino26OCT2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008169247 Female160.02 92.64 36.1 White Non-Hispanic/non -
Latino26OCT2020
C4591001 1008
1008169320 Female146.05 63.18 29.6 White Hispanic/Latino 26OCT2020
C4591001 1008
1008169547 Male 189.23 104.64 29.2 White Non-Hispanic/non -
Latino26OCT2020
C4591001 1008
1008169638 Female161.29 72.18 27.7 White Non-Hispanic/non -
Latino26OCT2020
C4591001 1008
1008169827 Female156.21 72.27 29.6 White Non-Hispanic/non -
Latino27OCT2020
C4591001 1008
1008170050 Female163.83 83 30.9 White Non-Hispanic/non -
Latino27OCT2020
C4591001 1008
1008170338 Male 167.64 53.27 18.9 White Hispanic/Latino 27OCT2020
C4591001 1008
1008170445 Male 184.15 91.91 27 White Non-Hispanic/non -
Latino27OCT2020
C4591001 1008
1008170633 Female156.21 78.09 31.9 White Non-Hispanic/non -
Latino27OCT2020
C4591001 1008
1008171053 Female161.29 92.91 35.6 White Non-Hispanic/non -
Latino28OCT2020
C4591001 1008
1008171251 Female149.86 68.55 30.5 White Hispanic/Latino 28OCT2020
C4591001 1008
1008171355 Male 177.8 109.86 34.7 White Non-Hispanic/non -
Latino28OCT2020
C4591001 1008
1008171545 Female 165.1 62.91 23 White Non-Hispanic/non -
Latino28OCT2020
C4591001 1008
1008171647 Male 190.5 106.91 29.4 White Non-Hispanic/non -
Latino28OCT2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008171746 Male 196.85 118.09 30.4 White Non-Hispanic/non -
Latino28OCT2020
C4591001 1008
1008171931 Female 165.1 102.73 37.6 White Non-Hispanic/non -
Latino28OCT2020
C4591001 1008
1008172052 Female154.94 72.45 30.1 Black or African American Non-Hispanic/non -
Latino28OCT2020
C4591001 1008
1008172137 Female167.64 67.45 23.9 White Non-Hispanic/non -
Latino29OCT2020
C4591001 1008
1008172255 Male 198.12 131.55 33.4 White Non-Hispanic/non -
Latino29OCT2020
C4591001 1008
1008172746 Female154.94 65.45 27.2 White Non-Hispanic/non -
Latino29OCT2020
C4591001 1008
1008172849 Male 190.5 113.36 31.2 White Non-Hispanic/non -
Latino29OCT2020
C4591001 1008
1008173140 Female157.48 53.55 21.5 White Non-Hispanic/non -
Latino30OCT2020
C4591001 1008
1008173352 Male 170.82 68.64 23.5 Asian Non-Hispanic/non -
Latino30OCT2020
C4591001 1008
1008173623 Male 185.42 88.09 25.6 White Non-Hispanic/non -
Latino30OCT2020
C4591001 1008
1008173751 Female167.64 65.73 23.3 Asian Non-Hispanic/non -
Latino30OCT2020
C4591001 1008
1008173850 Male 182.88 84.09 25.1 White Non-Hispanic/non -
Latino30OCT2020
C4591001 1008
1008173919 Male 173.99 129.09 42.5 White Non-Hispanic/non -
Latino30OCT2020
C4591001 1008
1008174116 Male 182.88 72.09 21.5 White Non-Hispanic/non -
Latino02NOV2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1008
1008174217 Male 179.07 60 18.7 White Non-Hispanic/non -
Latino03NOV2020
C4591001 1008
1008174316 Female160.02 46.73 18.2 Asian Non-Hispanic/non -
Latino04NOV2020
C4591001 1008
1008174417 Male 176.53 82.27 26.3 White Non-Hispanic/non -
Latino04NOV2020
C4591001 1008
1008174516 Male 182.88 64.55 19.3 White Non-Hispanic/non -
Latino12NOV2020
C4591001 1008
1008174617 Male 167.64 59 20.9 White Non-Hispanic/non -
Latino13NOV2020
C4591001 1009
1009100247 Male 183.52 106.36 31.5 White Non-Hispanic/non -
Latino07AUG2020
C4591001 1009
1009100531 Male 187.96 97 27.4 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1009
1009100650 Female 165.1 64 23.4 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1009
1009101245 Male 180.34 88.64 27.2 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1009
1009102153 Female173.99 68.64 22.6 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1009
1009102339 Female172.72 78.09 26.1 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1009
1009102818 Male 190.5 120.73 33.2 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1009
1009103054 Female 165.1 72.09 26.4 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1009
1009103132 Male 180.34 98.64 30.3 White Non-Hispanic/non -
Latino12AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1009
1009103252 Female 165.1 80 29.3 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1009
1009104238 Male 180.34 98.2 30.1 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1009
1009104545 Male 195.58 99.36 25.9 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1009
1009104650 Male 170.18 107.18 36.9 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1009
1009104937 Male 190.5 108.64 29.9 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1009
1009105050 Female 165.1 100.73 36.9 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1009
1009105322 Female166.37 76 27.4 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1009
1009105629 Female 177.8 73.18 23.1 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1009
1009105853 Female157.48 60.55 24.4 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1009
1009105951 Male 185.42 136.36 39.6 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1009
1009106135 Male 172.72 71.45 23.9 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1009
1009106336 Male 193.04 202.27 54.2 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1009
1009106623 Male 177.8 145.45 45.9 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1009
1009106848 Male 180.34 104.77 32.1 White Non-Hispanic/non -
Latino18AUG2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1009
1009107022 Female170.18 48.91 16.9 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1009
1009107343 Female166.37 65.64 23.7 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1009
1009107554 Male 177.8 86.64 27.3 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1009
1009107942 Male 177.8 101.36 32 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1009
1009108043 Female172.72 80.64 27 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1009
1009108152 Female154.94 58.18 24.2 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1009
1009108252 Male 172.21 70.91 23.9 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1009
1009108439 Female168.91 88.73 31 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1009
1009108537 Male 180.34 118.73 36.4 American Indian or Alaska
native Non-Hispanic/non -
Latino20AUG2020
C4591001 1009
1009108633 Male 170.18 67.64 23.3 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1009
1009108823 Male 185.42 70.73 20.5 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1009
1009109148 Female179.07 75.73 23.6 White Non-Hispanic/non -
Latino21AUG2020
C4591001 1009
1009109252 Female180.34 62.91 19.3 White Non-Hispanic/non -
Latino21AUG2020
C4591001 1009
1009109533 Female162.56 62.82 23.7 White Non-Hispanic/non -
Latino21AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1009
1009109754 Male 172.72 110.59 37 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1009
1009109831 Female 165.1 56.09 20.5 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1009
1009110222 Female162.56 60.91 23 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1009
1009110355 Female 177.8 109.18 34.5 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1009
1009110548 Female167.64 59.82 21.2 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1009
1009110643 Male 162.56 46.73 17.6 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1009
1009110832 Male 177.8 78.64 24.8 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1009
1009110950 Male 185.42 125.91 36.5 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1009
1009111046 Female170.18 67.45 23.2 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1009
1009111253 Female162.56 66.09 25 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1009
1009111332 Female 165.1 67.82 24.8 White Hispanic/Latino 26AUG2020
C4591001 1009
1009111645 Female154.94 78.18 32.5 White Hispanic/Latino 26AUG2020
C4591001 1009
1009111734 Female168.91 76.86 26.9 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1009
1009111854 Female 152.4 46.64 20 Asian Non-Hispanic/non -
Latino27AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1009
1009112440 Male 185.42 93.27 27.1 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1009
1009112851 Male 165.1 102.64 37.6 White Hispanic/Latino 28AUG2020
C4591001 1009
1009112938 Male 167.64 99.18 35.2 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1009
1009113128 Female162.56 105.73 39.9 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1009
1009113327 Female166.37 76.09 27.4 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1009
1009113421 Female171.45 67.14 22.8 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1009
1009113846 Female156.72 56 22.8 Asian Non-Hispanic/non -
Latino31AUG2020
C4591001 1009
1009114053 Female 165.1 67.09 24.6 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1009
1009114251 Male 180.34 89.55 27.5 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1009
1009114740 Female167.64 83.64 29.7 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1009
1009115852 Male 168.91 68.09 23.8 White Non-Hispanic/non -
Latino08SEP2020
C4591001 1009
1009115946 Male 182.88 92.27 27.5 White Non-Hispanic/non -
Latino08SEP2020
C4591001 1009
1009116353 Male 167.64 63 22.4 White Non-Hispanic/non -
Latino09SEP2020
C4591001 1009
1009116436 Female162.56 66.27 25 Multiracial Non-Hispanic/non -
Latino10SEP2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1009
1009116644 Female167.64 68.27 24.2 White Non-Hispanic/non -
Latino10SEP2020
C4591001 1009
1009117143 Female161.29 70.45 27 White Non-Hispanic/non -
Latino11SEP2020
C4591001 1009
1009117244 Female162.56 87.09 32.9 White Non-Hispanic/non -
Latino11SEP2020
C4591001 1009
1009117421 Male 185.42 136.18 39.5 White Non-Hispanic/non -
Latino14SEP2020
C4591001 1009
1009117550 Male 180.34 76.55 23.5 White Non-Hispanic/non -
Latino14SEP2020
C4591001 1009
1009117727 Female170.18 67.82 23.4 White Non-Hispanic/non -
Latino15SEP2020
C4591001 1009
1009117850 Male 175.26 174.09 56.6 White Non-Hispanic/non -
Latino15SEP2020
C4591001 1009
1009118350 Female175.26 80.82 26.3 White Non-Hispanic/non -
Latino17SEP2020
C4591001 1009
1009118454 Male 180.34 86.36 26.5 White Non-Hispanic/non -
Latino18SEP2020
C4591001 1009
1009118548 Female167.64 59.09 21 Asian Non-Hispanic/non -
Latino18SEP2020
C4591001 1009
1009118654 Male 187.96 78.55 22.2 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1009
1009118742 Male 167.64 65 23.1 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1009
1009118842 Female160.02 56.82 22.1 White Non-Hispanic/non -
Latino21SEP2020
C4591001 1009
1009119248 Male 186.69 108.36 31 White Non-Hispanic/non -
Latino24SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1009
1009119449 Female173.99 66.45 21.9 White Non-Hispanic/non -
Latino24SEP2020
C4591001 1009
1009119729 Female 165.1 127.32 46.6 White Hispanic/Latino 28SEP2020
C4591001 1009
1009119816 Female166.37 53.64 19.3 White Non-Hispanic/non -
Latino28SEP2020
C4591001 1009
1009120017 Male 168.91 59.27 20.7 White Non-Hispanic/non -
Latino29SEP2020
C4591001 1009
1009120117 Female153.67 43 18.2 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1009
1009120248 Female162.56 58.27 22 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1009
1009120330 Male 172.72 82.27 27.5 White Hispanic/Latino 15OCT2020
C4591001 1009
1009120649 Male 187.96 151.18 42.7 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1009
1009120718 Male 190.5 150.45 41.4 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1009
1009121016 Female160.66 44.73 17.3 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1009
1009121144 Female157.48 89.82 36.1 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1009
1009121447 Female162.56 59.09 22.3 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1009
1009121718 Female158.12 55.55 22.2 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1009
1009121943 Female 165.1 86.91 31.8 White Non-Hispanic/non -
Latino16OCT2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1009
1009122241 Female167.64 67.55 24 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1009
1009122417 Female173.99 74.09 24.4 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1009
1009122550 Male 170.18 71.36 24.6 Asian Non-Hispanic/non -
Latino20OCT2020
C4591001 1009
1009122853 Female167.64 58.18 20.7 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1009
1009123043 Female172.72 71.36 23.9 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1009
1009123241 Male 186.69 86.64 24.8 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1009
1009123516 Male 180.34 64.18 19.7 White Hispanic/Latino 21OCT2020
C4591001 1009
1009123645 Female154.94 62.45 26 White Hispanic/Latino 21OCT2020
C4591001 1009
1009123954 Male 190.5 100 27.5 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1009
1009124143 Male 170.18 68.18 23.5 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1009
1009124218 Male 177.8 74.27 23.4 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1009
1009124317 Female162.56 48.82 18.4 White Non-Hispanic/non -
Latino22OCT2020
C4591001 1009
1009124441 Female167.64 142.09 50.4 White Hispanic/Latino 22OCT2020
C4591001 1009
1009125241 Female160.02 87.91 34.3 White Non-Hispanic/non -
Latino23OCT2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1009
1009125339 Male 187.96 83.73 23.6 White Non-Hispanic/non -
Latino26OCT2020
C4591001 1009
1009125442 Male 173.99 86.82 28.6 White Non-Hispanic/non -
Latino26OCT2020
C4591001 1009
1009125516 Male 182.88 85 25.4 White Non-Hispanic/non -
Latino26OCT2020
C4591001 1009
1009125617 Female162.56 61.27 23.1 White Non-Hispanic/non -
Latino27OCT2020
C4591001 1009
1009125721 Female162.56 67.73 25.6 White Non-Hispanic/non -
Latino27OCT2020
C4591001 1009
1009125816 Male 185.42 69 20 White Non-Hispanic/non -
Latino03NOV2020
C4591001 1009
1009125917 Female179.07 81.09 25.2 White Non-Hispanic/non -
Latino03NOV2020
C4591001 1009
1009126016 Male 170.18 54.55 18.8 White Hispanic/Latino 11NOV2020
C4591001 1009
1009126117 Female157.48 99.36 40 White Non-Hispanic/non -
Latino11NOV2020
C4591001 1009
1009126217 Female171.45 68.27 23.2 White Non-Hispanic/non -
Latino13NOV2020
C4591001 1011
1011100145 Female160.02 74.55 29 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1011
1011100434 Male 175.26 87.55 28.4 White Hispanic/Latino 12AUG2020
C4591001 1011
1011100524 Male 165.1 92.82 34 Black or African American Hispanic/Latino 12AUG2020
C4591001 1011
1011100639 Male 175.26 81.64 26.5 Asian Non-Hispanic/non -
Latino12AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1011
1011100847 Female160.02 88.64 34.5 White Hispanic/Latino 12AUG2020
C4591001 1011
1011100955 Male 172.72 102.45 34.3 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1011
1011101342 Female161.29 123.73 47.5 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1011
1011101653 Female 152.4 73.64 31.6 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1011
1011101736 Male 175.26 95.45 31 Asian Non-Hispanic/non -
Latino13AUG2020
C4591001 1011
1011102146 Male 187.96 100 28.2 White Hispanic/Latino 13AUG2020
C4591001 1011
1011102450 Female154.94 79.64 33.1 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1011
1011103129 Male 180.34 115 35.3 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1011
1011103232 Female162.56 61.82 23.3 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1011
1011103427 Female175.26 84.27 27.4 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1011
1011103547 Female182.88 59.91 17.9 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1011
1011103848 Male 187.96 79.55 22.5 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1011
1011103940 Female157.48 129.55 52.1 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1011
1011104235 Male 180.34 68.18 20.9 White Hispanic/Latino 14AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1011
1011104319 Male 152.4 65.09 28 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1011
1011104449 Female149.86 67.73 30.1 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1011
1011104652 Female162.56 84 31.7 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1011
1011105228 Male 193.04 104.55 28 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1011
1011105335 Male 172.72 105 35.1 Asian Non-Hispanic/non -
Latino18AUG2020
C4591001 1011
1011107033 Male 172.72 84.09 28.1 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1011
1011107130 Female 165.1 63.09 23.1 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1011
1011107233 Female162.56 63.64 24 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1011
1011107440 Male 175.26 72.73 23.6 Black or African American Non-Hispanic/non -
Latino20AUG2020
C4591001 1011
1011107741 Female175.26 111.82 36.3 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1011
1011107829 Male 170.18 65.91 22.7 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1011
1011107936 Female180.34 78.18 24 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1011
1011108254 Female162.56 97.73 36.9 White Non-Hispanic/non -
Latino21AUG2020
C4591001 1011
1011108730 Male 179.07 103.18 32.1 White Non-Hispanic/non -
Latino24AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1011
1011108832 Female142.24 78.64 38.8 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1011
1011108950 Female157.48 68.18 27.4 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1011
1011109032 Male 187.96 87.27 24.6 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1011
1011109135 Male 182.88 81.82 24.4 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1011
1011109250 Male 175.26 109.09 35.4 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1011
1011109352 Female162.56 63.64 24 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1011
1011109439 Male 193.04 147.73 39.6 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1011
1011109527 Male 167.64 88.64 31.5 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1011
1011109737 Female170.18 95.45 32.9 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1011
1011109831 Male 175.26 138.64 45 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1011
1011110248 Female162.56 59.09 22.3 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1011
1011110443 Male 177.8 83.18 26.3 White Hispanic/Latino 26AUG2020
C4591001 1011
1011110643 Male 182.88 86.36 25.8 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1011
1011110753 Female167.64 109.09 38.7 White Non-Hispanic/non -
Latino27AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1011
1011111134 Male 170.18 77.27 26.6 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1011
1011111536 Male 185.42 106.82 31 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1011
1011111620 Female154.94 63.64 26.4 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1011
1011111751 Female162.56 75.64 28.6 Asian Non-Hispanic/non -
Latino27AUG2020
C4591001 1011
1011111824 Male 180.34 72.73 22.3 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1011
1011111952 Male 160.02 83.18 32.4 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1011
1011112233 Female 165.1 75 27.5 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1011
1011112348 Female 152.4 63.64 27.3 Black or African American Non-Hispanic/non -
Latino28AUG2020
C4591001 1011
1011112425 Male 177.8 63.64 20.1 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1011
1011112537 Female 177.8 84.09 26.5 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1011
1011112926 Female162.56 51.73 19.5 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1011
1011113040 Male 175.26 84.09 27.3 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1011
1011113428 Female 177.8 72.73 23 White Hispanic/Latino 01SEP2020
C4591001 1011
1011113535 Male 182.88 69.09 20.6 White Non-Hispanic/non -
Latino01SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1011
1011114149 Female154.94 65.91 27.4 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1011
1011114255 Female 165.1 125.45 45.9 Black or African American Non-Hispanic/non -
Latino01SEP2020
C4591001 1011
1011114351 Male 180.34 85.91 26.4 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1011
1011114439 Male 170.18 84.55 29.1 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1011
1011114839 Female157.48 90 36.2 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1011
1011115019 Male 182.88 63 18.8 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1011
1011115121 Female154.94 78.18 32.5 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1011
1011115433 Male 185.42 90.36 26.2 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1011
1011115947 Female167.64 81.73 29 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1011
1011116421 Female 152.4 48 20.6 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1011
1011116654 Female 165.1 98.68 36.1 White Hispanic/Latino 03SEP2020
C4591001 1011
1011116843 Male 180.34 86.36 26.5 Asian Non-Hispanic/non -
Latino16SEP2020
C4591001 1011
1011116930 Male 186.69 113.64 32.5 White Non-Hispanic/non -
Latino06OCT2020
C4591001 1011
1011117045 Female157.48 84.55 34 White Non-Hispanic/non -
Latino06OCT2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1011
1011117349 Male 185.42 78.18 22.7 White Non-Hispanic/non -
Latino07OCT2020
C4591001 1011
1011117424 Male 180.34 77.27 23.7 White Non-Hispanic/non -
Latino07OCT2020
C4591001 1011
1011117554 Female 165.1 73.64 27 White Non-Hispanic/non -
Latino07OCT2020
C4591001 1011
1011117642 Female162.56 61.36 23.2 White Non-Hispanic/non -
Latino07OCT2020
C4591001 1011
1011117944 Male 172.72 81.82 27.4 White Non-Hispanic/non -
Latino08OCT2020
C4591001 1011
1011118236 Male 167.64 80.45 28.6 White Non-Hispanic/non -
Latino08OCT2020
C4591001 1011
1011118355 Female 165.1 63.18 23.1 White Non-Hispanic/non -
Latino08OCT2020
C4591001 1011
1011118451 Male 170.18 52.27 18 White Non-Hispanic/non -
Latino08OCT2020
C4591001 1011
1011118653 Female160.02 64.09 25 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1011
1011119037 Female162.56 61.36 23.2 White Non-Hispanic/non -
Latino13OCT2020
C4591001 1011
1011119339 Male 180.34 93.91 28.8 White Non-Hispanic/non -
Latino14OCT2020
C4591001 1011
1011119550 Female154.94 62.27 25.9 White Non-Hispanic/non -
Latino14OCT2020
C4591001 1011
1011119753 Male 190.5 104.55 28.7 White Non-Hispanic/non -
Latino14OCT2020
C4591001 1011
1011119928 Female154.94 54.55 22.7 White Non-Hispanic/non -
Latino15OCT2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1011
1011120329 Female157.48 59.09 23.8 Asian Non-Hispanic/non -
Latino15OCT2020
C4591001 1011
1011121023 Female167.64 86.36 30.7 White Non-Hispanic/non -
Latino15OCT2020
C4591001 1011
1011121133 Male 182.88 84.09 25.1 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1011
1011121243 Female162.56 76.36 28.8 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1011
1011121322 Male 187.96 81.82 23.1 White Non-Hispanic/non -
Latino16OCT2020
C4591001 1011
1011121444 Female162.56 76.36 28.8 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1011
1011121523 Female157.48 52.27 21 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1011
1011121629 Male 175.26 74.55 24.2 White Non-Hispanic/non -
Latino19OCT2020
C4591001 1011
1011121927 Male 185.42 79.55 23.1 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1011
1011122037 Female175.26 68.18 22.1 White Non-Hispanic/non -
Latino20OCT2020
C4591001 1011
1011122254 Male 185.42 134.55 39 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1011
1011122437 Female162.56 65.91 24.9 White Non-Hispanic/non -
Latino21OCT2020
C4591001 1011
1011122751 Female154.94 72.73 30.2 White Non-Hispanic/non -
Latino23OCT2020
C4591001 1011
1011122852 Male 185.42 118.18 34.3 White Non-Hispanic/non -
Latino23OCT2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1011
1011123236 Male 185.42 79.55 23.1 White Non-Hispanic/non -
Latino27OCT2020
C4591001 1011
1011123351 Male 175.26 112.73 36.6 Asian Non-Hispanic/non -
Latino29OCT2020
C4591001 1011
1011123442 Male 149.86 99.09 44 Asian Non-Hispanic/non -
Latino29OCT2020
C4591001 1011
1011123539 Male 172.72 73.64 24.6 White Non-Hispanic/non -
Latino30OCT2020
C4591001 1011
1011123639 Male 175.26 84.09 27.3 White Non-Hispanic/non -
Latino30OCT2020
C4591001 1011
1011123737 Female175.26 106.82 34.7 Asian Non-Hispanic/non -
Latino30OCT2020
C4591001 1012
1012100141 Male 185.42 146.36 42.5 White Hispanic/Latino 03AUG2020
C4591001 1012
1012100351 Female154.94 76.36 31.7 White Hispanic/Latino 03AUG2020
C4591001 1012
1012100542 Female160.02 66.36 25.9 White Non-Hispanic/non -
Latino03AUG2020
C4591001 1012
1012100652 Male 175.26 74.09 24.1 White Non-Hispanic/non -
Latino03AUG2020
C4591001 1012
1012101350 Male 180.34 123.64 37.9 White Hispanic/Latino 05AUG2020
C4591001 1012
1012101454 Male 175.26 99.09 32.2 White Non-Hispanic/non -
Latino05AUG2020
C4591001 1012
1012101655 Male 180.34 101.82 31.2 White Non-Hispanic/non -
Latino06AUG2020
C4591001 1012
1012102049 Male 180.34 93.64 28.7 White Non-Hispanic/non -
Latino07AUG2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1012
1012102143 Female170.18 71.36 24.6 White Non-Hispanic/non -
Latino07AUG2020
C4591001 1012
1012102238 Male 175.26 75.45 24.5 White Hispanic/Latino 10AUG2020
C4591001 1012
1012102452 Male 177.8 87.73 27.7 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1012
1012102555 Male 180.34 82.73 25.4 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1012
1012102730 Male 177.8 109.09 34.4 White Hispanic/Latino 11AUG2020
C4591001 1012
1012103042 Male 172.72 90.91 30.4 White Hispanic/Latino 12AUG2020
C4591001 1012
1012103254 Male 182.88 82.73 24.7 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1012
1012103639 Female162.56 88.18 33.3 White Non-Hispanic/non -
Latino14AUG2020
C4591001 1012
1012103744 Female162.56 65 24.5 White Hispanic/Latino 14AUG2020
C4591001 1012
1012104347 Female154.94 40 16.6 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1012
1012104632 Female170.18 91.36 31.5 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1012
1012105130 Female167.64 61.36 21.8 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1012
1012105333 Male 177.8 103.64 32.7 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1012
1012105543 Male 175.26 87.27 28.4 White Non-Hispanic/non -
Latino20AUG2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1012
1012105845 Male 182.88 79.55 23.7 White Non-Hispanic/non -
Latino21AUG2020
C4591001 1012
1012105928 Female160.02 74.09 28.9 White Non-Hispanic/non -
Latino21AUG2020
C4591001 1012
1012106148 Female162.56 64.09 24.2 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1012
1012106535 Male 175.26 112.27 36.5 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1012
1012106651 Male 190.5 75.45 20.7 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1012
1012107231 Female170.18 73.18 25.2 Black or African American Non-Hispanic/non -
Latino26AUG2020
C4591001 1012
1012107354 Male 177.8 86.82 27.4 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1012
1012107436 Male 170.18 70.91 24.4 White Hispanic/Latino 26AUG2020
C4591001 1012
1012107655 Female147.32 45.45 20.9 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1012
1012107844 Male 175.26 110 35.7 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1012
1012107948 Male 190.5 127.27 35 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1012
1012108243 Male 152.4 100.91 43.4 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1012
1012108352 Female160.02 56.82 22.1 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1012
1012108552 Male 172.72 80 26.8 White Non-Hispanic/non -
Latino28AUG2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1012
1012108745 Female170.18 79.09 27.2 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1012
1012108952 Male 182.88 88.64 26.4 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1012
1012109050 Female172.72 63.64 21.3 White Non-Hispanic/non -
Latino28AUG2020
C4591001 1012
1012109142 Male 184.15 124.55 36.6 White Not reported 31AUG2020
C4591001 1012
1012109237 Female170.18 71.36 24.6 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1012
1012109537 Male 167.64 69.55 24.7 Asian Non-Hispanic/non -
Latino31AUG2020
C4591001 1012
1012109636 Male 180.34 108.18 33.2 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1012
1012110146 Female172.72 57.27 19.2 White Hispanic/Latino 01SEP2020
C4591001 1012
1012110250 Male 182.88 84.09 25.1 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1012
1012110327 Male 175.26 79.55 25.8 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1012
1012110438 Male 182.88 101.82 30.4 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1012
1012110555 Male 175.26 122.73 39.9 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1012
1012110737 Male 170.18 91.82 31.6 Not reported Non-Hispanic/non -
Latino01SEP2020
C4591001 1012
1012110840 Male 187.96 89.55 25.3 White Non-Hispanic/non -
Latino01SEP2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1012
1012111043 Male 182.88 82.73 24.7 Asian Non-Hispanic/non -
Latino01SEP2020
C4591001 1012
1012111148 Female170.18 68.18 23.5 White Hispanic/Latino 02SEP2020
C4591001 1012
1012111642 Male 177.8 80 25.3 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1012
1012111741 Female172.72 88.18 29.5 Asian Hispanic/Latino 02SEP2020
C4591001 1012
1012111835 Male 182.88 112.27 33.5 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1012
1012111928 Female 165.1 69.55 25.5 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1012
1012112148 Male 177.8 67.27 21.2 Asian Non-Hispanic/non -
Latino02SEP2020
C4591001 1012
1012112450 Female170.18 102.27 35.2 White Hispanic/Latino 03SEP2020
C4591001 1012
1012113042 Female175.26 87.27 28.4 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1012
1012113130 Male 190.5 85.91 23.6 White Hispanic/Latino 04SEP2020
C4591001 1012
1012113239 Female 177.8 106.36 33.6 White Non-Hispanic/non -
Latino04SEP2020
C4591001 1012
1012113347 Male 182.88 103.18 30.8 White Non-Hispanic/non -
Latino04SEP2020
C4591001 1012
1012113438 Female154.94 52.27 21.7 White Not reported 04SEP2020
C4591001 1012
1012113648 Female162.56 76.36 28.8 White Non-Hispanic/non -
Latino04SEP2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1012
1012113734 Male 182.88 84.09 25.1 White Non-Hispanic/non -
Latino04SEP2020
C4591001 1012
1012113840 Female172.72 99.09 33.1 Black or African American Non-Hispanic/non -
Latino05SEP2020
C4591001 1012
1012114139 Male 182.88 102.27 30.5 White Hispanic/Latino 05SEP2020
C4591001 1012
1012114340 Female162.56 64.09 24.2 White Non-Hispanic/non -
Latino05SEP2020
C4591001 1012
1012114423 Female162.56 45.45 17.2 White Non-Hispanic/non -
Latino05SEP2020
C4591001 1012
1012114533 Female167.64 98.64 35 White Hispanic/Latino 05SEP2020
C4591001 1012
1012114637 Female157.48 60 24.1 Asian Non-Hispanic/non -
Latino05SEP2020
C4591001 1012
1012115142 Male 180.34 73.64 22.6 White Non-Hispanic/non -
Latino08SEP2020
C4591001 1012
1012115339 Male 187.96 81.82 23.1 White Non-Hispanic/non -
Latino08SEP2020
C4591001 1012
1012115444 Female 165.1 96.82 35.4 White Non-Hispanic/non -
Latino08SEP2020
C4591001 1012
1012115546 Male 185.42 97.27 28.2 White Non-Hispanic/non -
Latino08SEP2020
C4591001 1012
1012115628 Male 182.88 79.55 23.7 White Hispanic/Latino 09SEP2020
C4591001 1012
1012115745 Male 177.8 102.27 32.3 White Hispanic/Latino 09SEP2020
C4591001 1012
1012115848 Female 165.1 64.55 23.6 White Non-Hispanic/non -
Latino09SEP2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1012
1012116253 Male 180.34 86.36 26.5 White Non-Hispanic/non -
Latino09SEP2020
C4591001 1012
1012116341 Female175.26 63.18 20.5 White Non-Hispanic/non -
Latino09SEP2020
C4591001 1012
1012116437 Male 187.96 158.64 44.8 White Hispanic/Latino 10SEP2020
C4591001 1012
1012116644 Female172.72 82.73 27.7 White Hispanic/Latino 10SEP2020
C4591001 1012
1012117247 Male 175.26 78.64 25.5 White Non-Hispanic/non -
Latino10SEP2020
C4591001 1012
1012117337 Male 187.96 108.64 30.7 White Hispanic/Latino 10SEP2020
C4591001 1012
1012117431 Female167.64 55.91 19.9 White Non-Hispanic/non -
Latino10SEP2020
C4591001 1012
1012117838 Female160.02 77.27 30.1 White Non-Hispanic/non -
Latino11SEP2020
C4591001 1012
1012118054 Female167.64 59.09 21 White Non-Hispanic/non -
Latino11SEP2020
C4591001 1012
1012118135 Male 182.88 70.45 21 White Non-Hispanic/non -
Latino11SEP2020
C4591001 1012
1012118230 Male 180.34 131.82 40.4 White Non-Hispanic/non -
Latino11SEP2020
C4591001 1012
1012118347 Male 177.8 101.82 32.1 White Non-Hispanic/non -
Latino11SEP2020
C4591001 1012
1012118524 Female154.94 60.45 25.1 White Hispanic/Latino 11SEP2020
C4591001 1012
1012118753 Male 172.72 75 25.1 White Non-Hispanic/non -
Latino11SEP2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1012
1012118824 Male 175.26 86.36 28.1 White Hispanic/Latino 11SEP2020
C4591001 1013
1013100224 Male 178.5 83.3 26.1 White Non-Hispanic/non -
Latino28JUL2020
C4591001 1013
1013100326 Female172.72 95.7 32.1 White Non-Hispanic/non -
Latino28JUL2020
C4591001 1013
1013100521 Female 162.9 61.7 23.3 White Hispanic/Latino 28JUL2020
C4591001 1013
1013100631 Male 186.1 137 39.6 White Hispanic/Latino 28JUL2020
C4591001 1013
1013100742 Female 158 50.6 20.3 Black or African American Non-Hispanic/non -
Latino28JUL2020
C4591001 1013
1013100846 Male 189 76 21.3 White Non-Hispanic/non -
Latino28JUL2020
C4591001 1013
1013100947 Male 188.4 112.2 31.6 White Non-Hispanic/non -
Latino28JUL2020
C4591001 1013
1013101054 Male 177.2 99.1 31.6 White Non-Hispanic/non -
Latino29JUL2020
C4591001 1013
1013101149 Male 178.3 67.6 21.3 White Non-Hispanic/non -
Latino29JUL2020
C4591001 1013
1013101234 Female 156.4 70.3 28.7 Asian Non-Hispanic/non -
Latino29JUL2020
C4591001 1013
1013101349 Female 162.5 96.3 36.5 White Hispanic/Latino 29JUL2020
C4591001 1013
1013101429 Male 178.2 86.7 27.3 Asian Non-Hispanic/non -
Latino29JUL2020
C4591001 1013
1013101539 Female 174.2 71.9 23.7 White Non-Hispanic/non -
Latino29JUL2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013101629 Male 172.7 90.3 30.3 Black or African American Non-Hispanic/non -
Latino29JUL2020
C4591001 1013
1013101827 Male 180.1 98.2 30.3 White Non-Hispanic/non -
Latino30JUL2020
C4591001 1013
1013101942 Male 168.5 69.9 24.6 White Non-Hispanic/non -
Latino30JUL2020
C4591001 1013
1013102024 Male 179.5 68.3 21.2 White Hispanic/Latino 30JUL2020
C4591001 1013
1013102133 Male 172.7 100.9 33.8 White Hispanic/Latino 30JUL2020
C4591001 1013
1013102255 Male 190.5 94.1 25.9 White Non-Hispanic/non -
Latino30JUL2020
C4591001 1013
1013102352 Female 170.4 71.4 24.6 White Non-Hispanic/non -
Latino30JUL2020
C4591001 1013
1013102448 Male 193 88.5 23.8 White Non-Hispanic/non -
Latino30JUL2020
C4591001 1013
1013102536 Male 178.5 77.4 24.3 White Non-Hispanic/non -
Latino30JUL2020
C4591001 1013
1013102618 Female 162 55.5 21.1 White Hispanic/Latino 30JUL2020
C4591001 1013
1013102735 Female 159.5 98.9 38.9 Black or African American Non-Hispanic/non -
Latino30JUL2020
C4591001 1013
1013103032 Female 163.1 89.4 33.6 White Non-Hispanic/non -
Latino30JUL2020
C4591001 1013
1013103148 Male 184 76.1 22.5 White Hispanic/Latino 30JUL2020
C4591001 1013
1013103227 Female 166 75 27.2 White Non-Hispanic/non -
Latino30JUL2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013103331 Female 162.6 63.6 24.1 White Non-Hispanic/non -
Latino31JUL2020
C4591001 1013
1013103445 Male 171.1 64.4 22 Asian Non-Hispanic/non -
Latino31JUL2020
C4591001 1013
1013103547 Female 163.9 71.8 26.7 White Non-Hispanic/non -
Latino31JUL2020
C4591001 1013
1013103647 Female 162.6 70 26.5 White Hispanic/Latino 31JUL2020
C4591001 1013
1013103853 Female 156.5 63.2 25.8 Asian Non-Hispanic/non -
Latino31JUL2020
C4591001 1013
1013103929 Female 170.8 63.1 21.6 White Hispanic/Latino 31JUL2020
C4591001 1013
1013104028 Female 170.8 51.3 17.6 White Non-Hispanic/non -
Latino31JUL2020
C4591001 1013
1013104252 Male 182.8 111.4 33.3 Black or African American Non-Hispanic/non -
Latino31JUL2020
C4591001 1013
1013104451 Male 183.1 85.3 25.4 Black or African American Non-Hispanic/non -
Latino31JUL2020
C4591001 1013
1013104553 Female 171.5 81.2 27.6 Black or African American Non-Hispanic/non -
Latino31JUL2020
C4591001 1013
1013104649 Male 172.7 67.1 22.5 White Hispanic/Latino 31JUL2020
C4591001 1013
1013104740 Female 174.1 77.6 25.6 Black or African American Non-Hispanic/non -
Latino31JUL2020
C4591001 1013
1013104837 Female 167.6 63.5 22.6 Multiracial Non-Hispanic/non -
Latino31JUL2020
C4591001 1013
1013104953 Male 176 56 18.1 Black or African American Non-Hispanic/non -
Latino31JUL2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013105054 Female 153.7 48.6 20.6 White Non-Hispanic/non -
Latino31JUL2020
C4591001 1013
1013105133 Female 180.1 70.4 21.7 White Non-Hispanic/non -
Latino03AUG2020
C4591001 1013
1013105230 Male 184 103.2 30.5 Asian Non-Hispanic/non -
Latino03AUG2020
C4591001 1013
1013105436 Male 189.5 100.8 28.1 White Non-Hispanic/non -
Latino03AUG2020
C4591001 1013
1013105540 Male 170.1 81.2 28.1 White Non-Hispanic/non -
Latino03AUG2020
C4591001 1013
1013105640 Female 170.2 117.9 40.7 White Non-Hispanic/non -
Latino03AUG2020
C4591001 1013
1013105729 Female 162.2 81.8 31.1 White Non-Hispanic/non -
Latino03AUG2020
C4591001 1013
1013105843 Male 172 67.6 22.9 Black or African American Non-Hispanic/non -
Latino03AUG2020
C4591001 1013
1013105924 Female 161.5 43.7 16.8 White Non-Hispanic/non -
Latino03AUG2020
C4591001 1013
1013106023 Male 187 75.4 21.6 White Hispanic/Latino 03AUG2020
C4591001 1013
1013106249 Male 188.7 97.1 27.3 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1013
1013106347 Male 182 83.4 25.2 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1013
1013106428 Female 179.8 104.1 32.2 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1013
1013106648 Female 162.5 69.5 26.3 White Non-Hispanic/non -
Latino04AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013106729 Female 167.8 91.1 32.4 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1013
1013106838 Female 163.3 92.5 34.7 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1013
1013107155 Male 180.18 101 31.1 Multiracial Non-Hispanic/non -
Latino04AUG2020
C4591001 1013
1013107250 Female 171.1 78.8 26.9 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1013
1013107440 Female 169.1 63.6 22.2 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1013
1013107640 Female 172.7 91.8 30.8 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1013
1013107725 Male 172.5 112.8 37.9 White Hispanic/Latino 04AUG2020
C4591001 1013
1013107837 Male 180.3 78.6 24.2 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1013
1013107936 Male 179.9 99.1 30.6 White Non-Hispanic/non -
Latino04AUG2020
C4591001 1013
1013108139 Male 177.5 67.2 21.3 White Non-Hispanic/non -
Latino05AUG2020
C4591001 1013
1013108241 Female 169.6 82.5 28.7 White Non-Hispanic/non -
Latino05AUG2020
C4591001 1013
1013108354 Male 176.2 94.7 30.5 White Hispanic/Latino 05AUG2020
C4591001 1013
1013108449 Female 157 57.6 23.4 White Hispanic/Latino 05AUG2020
C4591001 1013
1013108744 Male 177 85.1 27.2 White Hispanic/Latino 05AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013108929 Female 153.4 52.5 22.3 White Non-Hispanic/non -
Latino06AUG2020
C4591001 1013
1013109045 Female 159 74 29.3 White Non-Hispanic/non -
Latino06AUG2020
C4591001 1013
1013109354 Female 152.9 64.6 27.6 White Hispanic/Latino 06AUG2020
C4591001 1013
1013109443 Male 176 81.7 26.4 White Non-Hispanic/non -
Latino06AUG2020
C4591001 1013
1013109855 Male 179 98.6 30.8 Black or African American Non-Hispanic/non -
Latino06AUG2020
C4591001 1013
1013110239 Male 187.9 100 28.3 White Hispanic/Latino 06AUG2020
C4591001 1013
1013110343 Male 182 80 24.2 White Hispanic/Latino 06AUG2020
C4591001 1013
1013110550 Male 176 83.1 26.8 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1013
1013110648 Male 175.2 81.8 26.6 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1013
1013110745 Male 177.8 77.3 24.5 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1013
1013110836 Male 175.3 77.3 25.2 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1013
1013110942 Female 165.1 60.4 22.2 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1013
1013111140 Male 185.4 75.6 22 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1013
1013111240 Male 182.8 97.7 29.2 White Non-Hispanic/non -
Latino10AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013111329 Male 185.5 76 22.1 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1013
1013111555 Male 168.9 100 35.1 White Hispanic/Latino 10AUG2020
C4591001 1013
1013111649 Male 176.1 102.6 33.1 Asian Non-Hispanic/non -
Latino10AUG2020
C4591001 1013
1013111739 Male 185.4 86.3 25.1 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1013
1013111827 Male 176.9 79.2 25.3 Asian Non-Hispanic/non -
Latino10AUG2020
C4591001 1013
1013111944 Female 162.5 61.4 23.3 White Hispanic/Latino 10AUG2020
C4591001 1013
1013112034 Male 177.6 66.7 21.1 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1013
1013112123 Female 168 64 22.7 White Non-Hispanic/non -
Latino10AUG2020
C4591001 1013
1013112234 Male 183.8 86.8 25.7 Black or African American Non-Hispanic/non -
Latino10AUG2020
C4591001 1013
1013112441 Male 165.4 88.5 32.3 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1013
1013112536 Male 187.9 136 38.5 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1013
1013112651 Female 160 63.6 24.8 Asian Non-Hispanic/non -
Latino11AUG2020
C4591001 1013
1013112741 Female 162.6 56.5 21.4 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1013
1013112851 Female 157.4 122.4 49.4 White Non-Hispanic/non -
Latino11AUG2020
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013113141 Female 168.1 80 28.3 Native Hawaiian or other
Pacific IslanderNon-Hispanic/non -
Latino11AUG2020
C4591001 1013
1013113241 Male 172.5 86 28.9 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1013
1013113455 Male 170.2 86.2 29.8 White Hispanic/Latino 11AUG2020
C4591001 1013
1013113543 Male 170.2 60.4 20.9 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1013
1013113641 Male 189 132.4 37.1 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1013
1013113751 Male 181 109.6 33.5 Black or African American Non-Hispanic/non -
Latino11AUG2020
C4591001 1013
1013113855 Male 175.3 63.6 20.7 Black or African American Non-Hispanic/non -
Latino11AUG2020
C4591001 1013
1013113927 Male 178.1 116.1 36.6 White Non-Hispanic/non -
Latino11AUG2020
C4591001 1013
1013114345 Male 172.7 63.5 21.3 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1013
1013114526 Female 172.7 113.6 38.1 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1013
1013114627 Male 172.7 81.8 27.4 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1013
1013114726 Female 160 54.5 21.3 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1013
1013114846 Female 165 97.7 35.9 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1013
1013114936 Male 175.4 83.1 27 White Non-Hispanic/non -
Latino12AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013115554 Female 154.1 65.2 27.5 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1013
1013115631 Female 167.6 68 24.2 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1013
1013115831 Female 170.6 71.7 24.6 White Non-Hispanic/non -
Latino12AUG2020
C4591001 1013
1013115940 Male 170.2 68.8 23.8 Asian Non-Hispanic/non -
Latino12AUG2020
C4591001 1013
1013116342 Female 155.6 68.7 28.4 Asian Non-Hispanic/non -
Latino13AUG2020
C4591001 1013
1013116528 Male 183 86 25.7 White Hispanic/Latino 13AUG2020
C4591001 1013
1013116650 Male 160.5 81.4 31.6 Asian Non-Hispanic/non -
Latino13AUG2020
C4591001 1013
1013116750 Female 157.2 81.5 33 Asian Non-Hispanic/non -
Latino13AUG2020
C4591001 1013
1013116926 Female 165 55 20.2 White Hispanic/Latino 13AUG2020
C4591001 1013
1013117121 Female 160 68 26.6 White Hispanic/Latino 13AUG2020
C4591001 1013
1013117227 Male 185 124 36.2 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1013
1013117339 Female 179.2 114.8 35.7 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1013
1013117420 Female 165.1 86.2 31.6 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1013
1013117754 Male 180.6 100.7 30.9 White Non-Hispanic/non -
Latino13AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013117936 Male 177.8 84.1 26.6 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1013
1013118039 Female 160 78.6 30.7 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1013
1013118251 Female 170 71 24.6 White Non-Hispanic/non -
Latino13AUG2020
C4591001 1013
1013118536 Male 179.8 78.1 24.2 White Hispanic/Latino 13AUG2020
C4591001 1013
1013118749 Male 179.4 100.6 31.3 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1013
1013118848 Female 178 118 37.2 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1013
1013119046 Female 167.6 65.7 23.4 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1013
1013119545 Female 167.6 78.4 27.9 White Hispanic/Latino 17AUG2020
C4591001 1013
1013119628 Female 156.8 37.9 15.4 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1013
1013119726 Female 164 61.8 23 White Hispanic/Latino 17AUG2020
C4591001 1013
1013119950 Female 168 91.8 32.5 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1013
1013120024 Male 177.6 80.9 25.6 Asian Non-Hispanic/non -
Latino17AUG2020
C4591001 1013
1013120454 Male 167.6 81.7 29.1 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1013
1013120542 Male 171 84.3 28.8 Black or African American Non-Hispanic/non -
Latino17AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013120752 Female 163 79.9 30.1 White Non-Hispanic/non -
Latino17AUG2020
C4591001 1013
1013120952 Female 170.5 84.6 29.1 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1013
1013121040 Male 180.5 76.8 23.6 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1013
1013121150 Male 185.4 114.8 33.4 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1013
1013121451 Male 179.1 86.7 27 White Hispanic/Latino 18AUG2020
C4591001 1013
1013121546 Female 153.5 59.3 25.2 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1013
1013121645 Female 160 74.8 29.2 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1013
1013121833 Male 167.6 76.4 27.2 White Hispanic/Latino 18AUG2020
C4591001 1013
1013121955 Female 152.6 65.1 28 White Hispanic/Latino 18AUG2020
C4591001 1013
1013122043 Male 192.9 116.5 31.3 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1013
1013122141 Male 182 82.9 25 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1013
1013122351 Male 176.7 77.5 24.8 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1013
1013122455 Female 162.5 56.3 21.3 White Non-Hispanic/non -
Latino18AUG2020
C4591001 1013
1013122547 Male 178 95.3 30.1 White Non-Hispanic/non -
Latino18AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013122845 Male 176.9 101.1 32.3 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1013
1013122925 Female 162.6 79.3 30 Asian Non-Hispanic/non -
Latino19AUG2020
C4591001 1013
1013123153 Male 177.8 120 38 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1013
1013123746 Male 179.1 78.3 24.4 Black or African American Non-Hispanic/non -
Latino19AUG2020
C4591001 1013
1013123826 Male 176.4 76.9 24.7 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1013
1013123935 Male 178.5 89.4 28.1 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1013
1013124142 Female 171.8 129.4 43.8 White Non-Hispanic/non -
Latino19AUG2020
C4591001 1013
1013124554 Female 162.6 67.3 25.5 White Hispanic/Latino 19AUG2020
C4591001 1013
1013124619 Female 160.5 60.4 23.4 White Hispanic/Latino 19AUG2020
C4591001 1013
1013125045 Male 185.4 127.3 37 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1013
1013125143 Male 183.5 82.1 24.4 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1013
1013125244 Male 180.3 87.1 26.8 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1013
1013125442 Male 182.5 107.1 32.2 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1013
1013125530 Female 178 60.5 19.1 White Non-Hispanic/non -
Latino20AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013125631 Male 188.5 91.9 25.9 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1013
1013125851 Male 170.2 92.3 31.9 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1013
1013125933 Female 164.5 67.6 25 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1013
1013126350 Male 180.9 93.9 28.7 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1013
1013126451 Male 178.2 101.3 31.9 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1013
1013126644 Male 168.3 71.7 25.3 White Hispanic/Latino 20AUG2020
C4591001 1013
1013126743 Female 152.4 65.7 28.3 Asian Non-Hispanic/non -
Latino20AUG2020
C4591001 1013
1013126845 Male 185.4 118.3 34.4 Asian Non-Hispanic/non -
Latino20AUG2020
C4591001 1013
1013126936 Male 168.2 77.5 27.4 White Non-Hispanic/non -
Latino20AUG2020
C4591001 1013
1013127136 Female 170.2 111.4 38.5 Black or African American Non-Hispanic/non -
Latino24AUG2020
C4591001 1013
1013127543 Female 138.2 66.5 34.8 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1013
1013127624 Female 162.5 53.9 20.4 White Hispanic/Latino 24AUG2020
C4591001 1013
1013128051 Male 170.2 95 32.8 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1013
1013128144 Male 177.8 84.1 26.6 Asian Non-Hispanic/non -
Latino24AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013128352 Male 175.2 81.6 26.6 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1013
1013128538 Female 173.5 91 30.2 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1013
1013128748 Male 190.4 88.5 24.4 American Indian or Alaska
native Non-Hispanic/non -
Latino24AUG2020
C4591001 1013
1013128853 Male 193 115.9 31.1 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1013
1013129043 Male 181.2 100.9 30.7 White Non-Hispanic/non -
Latino24AUG2020
C4591001 1013
1013129148 Male 170.2 84.1 29 White Hispanic/Latino 24AUG2020
C4591001 1013
1013129255 Male 185.4 71.8 20.9 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1013
1013129341 Male 175.4 77.9 25.3 Asian Non-Hispanic/non -
Latino25AUG2020
C4591001 1013
1013129644 Male 178.8 82.3 25.7 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1013
1013129953 Female 160 79.3 31 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1013
1013130245 Male 170.2 74.1 25.6 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1013
1013130332 Male 165.4 79.9 29.2 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1013
1013130451 Female 166 64.7 23.5 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1013
1013130531 Male 176 75.6 24.4 White Hispanic/Latino 25AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013130748 Male 173 110.5 36.9 Black or African American Non-Hispanic/non -
Latino25AUG2020
C4591001 1013
1013130836 Female 166 57.7 20.9 Black or African American Non-Hispanic/non -
Latino25AUG2020
C4591001 1013
1013130928 Female 152.4 46.8 20.2 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1013
1013131141 Male 181.3 100.5 30.6 Black or African American Non-Hispanic/non -
Latino25AUG2020
C4591001 1013
1013131226 Female 172.7 95.4 32 White Non-Hispanic/non -
Latino25AUG2020
C4591001 1013
1013131344 Female 162.2 98.6 37.5 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1013
1013131529 Female 177.8 69.4 22 White Hispanic/Latino 26AUG2020
C4591001 1013
1013131631 Male 178.1 121.9 38.4 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1013
1013131747 Male 172.7 78.2 26.2 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1013
1013131844 Female 164.8 74.5 27.4 White Non-Hispanic/non -
Latino26AUG2020
C4591001 1013
1013131924 Male 172.7 63.9 21.4 Asian Non-Hispanic/non -
Latino26AUG2020
C4591001 1013
1013132152 Male 172.7 113.4 38 White Hispanic/Latino 26AUG2020
C4591001 1013
1013132227 Male 183.2 135.6 40.4 Asian Non-Hispanic/non -
Latino26AUG2020
C4591001 1013
1013132547 Male 186.1 82.9 23.9 White Non-Hispanic/non -
Latino26AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013133231 Male 182.5 108.1 32.5 Black or African American Non-Hispanic/non -
Latino26AUG2020
C4591001 1013
1013133829 Male 170.2 63.6 22 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1013
1013133933 Female 163.6 123.4 46.1 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1013
1013134055 Male 173.4 82.7 27.5 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1013
1013134355 Male 177.2 90 28.7 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1013
1013134847 Male 163.5 90.8 34 Black or African American Non-Hispanic/non -
Latino27AUG2020
C4591001 1013
1013134946 Female 164.5 89.6 33.1 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1013
1013135142 Male 170.1 81.6 28.2 White Hispanic/Latino 27AUG2020
C4591001 1013
1013135226 Male 162.5 78.6 29.8 White Hispanic/Latino 27AUG2020
C4591001 1013
1013135323 Female 163.5 62.9 23.5 White Non-Hispanic/non -
Latino27AUG2020
C4591001 1013
1013135533 Male 170.1 75.5 26.1 Asian Non-Hispanic/non -
Latino31AUG2020
C4591001 1013
1013135750 Male 195.6 100 26.1 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1013
1013136155 Male 173.8 68.6 22.7 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1013
1013136447 Female 186 105.1 30.4 White Non-Hispanic/non -
Latino31AUG2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013136547 Male 188 94 26.6 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1013
1013136623 Male 182.8 72.7 21.8 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1013
1013137046 Male 178.6 79.6 25 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1013
1013137125 Female 177.2 53.4 17 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1013
1013137322 Female 183.8 67.5 20 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1013
1013137549 Female 170.5 66.2 22.8 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1013
1013137653 Female 162.1 61.2 23.3 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1013
1013137743 Male 180 82.9 25.6 White Non-Hispanic/non -
Latino31AUG2020
C4591001 1013
1013137944 Female 173 80 26.7 White Hispanic/Latino 01SEP2020
C4591001 1013
1013138134 Female 181.4 78.1 23.7 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1013
1013138350 Female 175.8 82.9 26.8 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1013
1013138546 Female 162.1 64.8 24.7 White Hispanic/Latino 01SEP2020
C4591001 1013
1013138840 Female 163 63 23.7 White Hispanic/Latino 01SEP2020
C4591001 1013
1013138941 Male 175.3 65 21.2 Asian Non-Hispanic/non -
Latino01SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013139143 Male 192.8 112.8 30.3 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1013
1013139424 Male 181.9 69.4 21 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1013
1013139520 Male 184.1 68.4 20.2 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1013
1013139641 Male 179 83.6 26.1 White Non-Hispanic/non -
Latino01SEP2020
C4591001 1013
1013139743 Female 161 89 34.3 Black or African American Non-Hispanic/non -
Latino01SEP2020
C4591001 1013
1013139836 Male 184.8 87.1 25.5 White Hispanic/Latino 02SEP2020
C4591001 1013
1013140039 Female 171 106.2 36.3 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1013
1013140140 Female 163 91.8 34.6 White Hispanic/Latino 02SEP2020
C4591001 1013
1013140353 Male 171.8 86.8 29.4 White Hispanic/Latino 02SEP2020
C4591001 1013
1013140545 Female 170.2 100 34.5 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1013
1013140651 Male 172 82.6 27.9 Asian Non-Hispanic/non -
Latino02SEP2020
C4591001 1013
1013140740 Male 180.6 89.4 27.4 Black or African American Non-Hispanic/non -
Latino02SEP2020
C4591001 1013
1013140839 Female 171 114 39 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1013
1013140935 Male 198.5 146 37.1 White Non-Hispanic/non -
Latino02SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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16.2.4.4 Listing of Demographic Characteristics – All Subjects
Age
Group
(Years) SubjectAge
(Years) SexHeight
(cm)Weight
(kg)Body
Mass
Index
(BMI)
(kg/m2) Race EthnicityInformed Consent Date
(Screening)
C4591001 1013
1013141129 Male 177.8 116.4 36.8 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1013
1013141250 Male 177.2 88.1 28.1 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1013
1013141321 Female 168.5 107 37.7 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1013
1013141654 Female 162.6 53.6 20.3 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1013
1013141748 Female 163 53.5 20.1 White Hispanic/Latino 02SEP2020
C4591001 1013
1013141847 Male 181 112.4 34.3 White Hispanic/Latino 02SEP2020
C4591001 1013
1013141953 Male 182.9 75 22.4 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1013
1013142048 Female 168.4 65.2 23 White Non-Hispanic/non -
Latino02SEP2020
C4591001 1013
1013142120 Female 171.2 78.8 26.9 White Hispanic/Latino 02SEP2020
C4591001 1013
1013142220 Female 150.8 43.8 19.3 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1013
1013142334 Female 163.1 87.6 32.9 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1013
1013142419 Male 157 60.1 24.4 White Hispanic/Latino 03SEP2020
C4591001 1013
1013142523 Female 147.3 63.6 29.3 White Non-Hispanic/non -
Latino03SEP2020
C4591001 1013
1013142620 Male 175.4 92.7 30.1 Black or African American Non-Hispanic/non -
Latino03SEP2020
090177e1959b0964\Final\Final On: 24-Nov-2020 13:48 (GMT)
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…[truncated]