125742 S1 M5 5351 c4591001 interim mth6 demographics
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16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) 16-55 C4591001 1001 10011085 25 Female 174.3 53.4 17.6 White Non-Hispanic/non- Latino28JUL2020 C4591001 1001 10011086 52 Male 172.7 68.9 23.1 White Non-Hispanic/non- Latino28JUL2020 C4591001 1001 10011087 45 Male 175 83.1 27.1 White Non-Hispanic/non- Latino28JUL2020 C4591001 1001 10011088 44 Female 161.9 49.8 19 Asian Non-Hispanic/non- Latino28JUL2020 C4591001 1001 10011089 37 Female 165 74.1 27.2 Not reported Non-Hispanic/non- Latino28JUL2020 C4591001 1001 10011091 45 Male 172 78.2 26.4 White Non-Hispanic/non- Latino29JUL2020 C4591001 1001 10011092 45 Male 170.7 67 23 Asian Non-Hispanic/non- Latino29JUL2020 C4591001 1001 10011095 39 Male 181.3 75 22.8 White Non-Hispanic/non- Latino29JUL2020 C4591001 1001 10011101 28 Male 185.5 132.5 38.5 Black or African American Hispanic/Latino 30JUL2020 C4591001 1001 10011102 26 Female 166.2 59 21.4 Not reported Hispanic/Latino 30JUL2020 C4591001 1003 10031088 26 Female 165.1 58.64 21.5 White Non-Hispanic/non- Latino27JUL2020 C4591001 1003 10031090 45 Female 152.4 96.36 41.4 White Non-Hispanic/non- Latino27JUL2020 C4591001 1003 10031094 42 Male 180.34 108.64 33.3 White Non-Hispanic/non- Latino28JUL2020 C4591001 1003 10031096 28 Male 167.64 82.27 29.2 Black or African American Non-Hispanic/non- Latino28JUL2020 C4591001 1003 10031097 51 Female 154.94 70.45 29.3 White Non-Hispanic/non- Latino28JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 1 FDA-CBER-2021-5683-0032371 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1003 10031100 42 Male 185.42 121.82 35.4 White Non-Hispanic/non- Latino28JUL2020 C4591001 1003 10031101 43 Male 180.34 84.55 25.9 White Non-Hispanic/non- Latino28JUL2020 C4591001 1003 10031104 42 Male 172.72 86.18 28.8 White Non-Hispanic/non- Latino29JUL2020 C4591001 1003 10031111 25 Male 180.34 81.82 25.1 White Non-Hispanic/non- Latino30JUL2020 C4591001 1003 10031115 38 Female 162.56 50.91 19.2 Asian Non-Hispanic/non- Latino30JUL2020 C4591001 1007 10071080 46 Male 176.4 86.4 27.8 Asian Non-Hispanic/non- Latino28JUL2020 C4591001 1007 10071082 25 Female 175.2 118.8 38.7 Black or African American Non-Hispanic/non- Latino28JUL2020 C4591001 1007 10071083 54 Male 179 85.1 26.6 Black or African American Non-Hispanic/non- Latino28JUL2020 C4591001 1007 10071087 29 Female 162.4 78.6 29.8 White Non-Hispanic/non- Latino29JUL2020 C4591001 1007 10071089 49 Female 184.5 116 34.1 White Non-Hispanic/non- Latino29JUL2020 C4591001 1007 10071092 49 Male 183 117.3 35 White Non-Hispanic/non- Latino29JUL2020 C4591001 1007 10071093 37 Male 181.5 92.2 28 Black or African American Non-Hispanic/non- Latino29JUL2020 C4591001 1007 10071095 38 Male 185.5 98.6 28.7 White Non-Hispanic/non- Latino30JUL2020 C4591001 1007 10071096 34 Female 165 84.9 31.2 White Non-Hispanic/non- Latino30JUL2020 C4591001 1007 10071097 49 Female 172 100.5 34 White Non-Hispanic/non- Latino30JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 2 FDA-CBER-2021-5683-0032372 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1007 10071100 52 Female 164 66.1 24.6 White Non-Hispanic/non- Latino30JUL2020 C4591001 1007 10071102 54 Female 156 97.8 40.2 White Non-Hispanic/non- Latino30JUL2020 C4591001 1013 10131002 24 Male 178.5 83.3 26.1 White Non-Hispanic/non- Latino28JUL2020 C4591001 1013 10131003 26 Female 172.72 95.7 32.1 White Non-Hispanic/non- Latino28JUL2020 C4591001 1013 10131005 21 Female 162.9 61.7 23.3 White Hispanic/Latino 28JUL2020 C4591001 1013 10131006 31 Male 186.1 137 39.6 White Hispanic/Latino 28JUL2020 C4591001 1013 10131007 42 Female 158 50.6 20.3 Black or African American Non-Hispanic/non- Latino28JUL2020 C4591001 1013 10131008 46 Male 189 76 21.3 White Non-Hispanic/non- Latino28JUL2020 C4591001 1013 10131009 47 Male 188.4 112.2 31.6 White Non-Hispanic/non- Latino28JUL2020 C4591001 1013 10131010 54 Male 177.2 99.1 31.6 White Non-Hispanic/non- Latino29JUL2020 C4591001 1013 10131011 49 Male 178.3 67.6 21.3 White Non-Hispanic/non- Latino29JUL2020 C4591001 1013 10131012 34 Female 156.4 70.3 28.7 Asian Non-Hispanic/non- Latino29JUL2020 C4591001 1013 10131013 49 Female 162.5 96.3 36.5 White Hispanic/Latino 29JUL2020 C4591001 1013 10131014 29 Male 178.2 86.7 27.3 Asian Non-Hispanic/non- Latino29JUL2020 C4591001 1013 10131015 39 Female 174.2 71.9 23.7 White Non-Hispanic/non- Latino29JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 3 FDA-CBER-2021-5683-0032373 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1013 10131016 29 Male 172.7 90.3 30.3 Black or African American Non-Hispanic/non- Latino29JUL2020 C4591001 1013 10131018 27 Male 180.1 98.2 30.3 White Non-Hispanic/non- Latino30JUL2020 C4591001 1013 10131019 42 Male 168.5 69.9 24.6 White Non-Hispanic/non- Latino30JUL2020 C4591001 1013 10131020 24 Male 179.5 68.3 21.2 White Hispanic/Latino 30JUL2020 C4591001 1013 10131021 33 Male 172.7 100.9 33.8 White Hispanic/Latino 30JUL2020 C4591001 1013 10131022 55 Male 190.5 94.1 25.9 White Non-Hispanic/non- Latino30JUL2020 C4591001 1013 10131023 52 Female 170.4 71.4 24.6 White Non-Hispanic/non- Latino30JUL2020 C4591001 1013 10131024 48 Male 193 88.5 23.8 White Non-Hispanic/non- Latino30JUL2020 C4591001 1013 10131025 36 Male 178.5 77.4 24.3 White Non-Hispanic/non- Latino30JUL2020 C4591001 1013 10131026 18 Female 162 55.5 21.1 White Hispanic/Latino 30JUL2020 C4591001 1013 10131030 32 Female 163.1 89.4 33.6 White Non-Hispanic/non- Latino30JUL2020 C4591001 1013 10131031 48 Male 184 76.1 22.5 White Hispanic/Latino 30JUL2020 C4591001 1013 10131032 27 Female 166 75 27.2 White Non-Hispanic/non- Latino30JUL2020 C4591001 1016 10161003 23 Female 170.18 64.18 22.1 White Non-Hispanic/non- Latino29JUL2020 C4591001 1016 10161004 51 Female 165.1 66.18 24.2 White Non-Hispanic/non- Latino29JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 4 FDA-CBER-2021-5683-0032374 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1016 10161005 54 Female 162.56 79 29.8 White Non-Hispanic/non- Latino29JUL2020 C4591001 1016 10161006 51 Female 165.1 95.91 35.1 Black or African American Non-Hispanic/non- Latino29JUL2020 C4591001 1016 10161009 45 Female 170.18 135.45 46.7 White Non-Hispanic/non- Latino30JUL2020 C4591001 1016 10161010 21 Male 177.8 69.73 22 White Not reported 30JUL2020 C4591001 1016 10161014 24 Female 156.21 75 30.7 White Non-Hispanic/non- Latino30JUL2020 C4591001 1018 10181001 45 Male 180.34 112 34.4 White Non-Hispanic/non- Latino29JUL2020 C4591001 1018 10181003 33 Male 185.42 93 27 Black or African American Non-Hispanic/non- Latino29JUL2020 C4591001 1018 10181007 22 Male 177.8 64.82 20.5 Black or African American Non-Hispanic/non- Latino29JUL2020 C4591001 1042 10421001 45 Male 180 99.5 30.7 White Non-Hispanic/non- Latino29JUL2020 C4591001 1042 10421003 22 Female 165.1 68.18 25 White Non-Hispanic/non- Latino29JUL2020 C4591001 1042 10421004 22 Male 165.1 71.91 26.3 Black or African American Non-Hispanic/non- Latino29JUL2020 C4591001 1042 10421008 46 Male 182.88 75 22.4 White Non-Hispanic/non- Latino30JUL2020 C4591001 1073 10731006 55 Male 168.05 83.3 29.5 White Hispanic/Latino 30JUL2020 C4591001 1073 10731008 55 Male 171.5 93.1 31.7 White Non-Hispanic/non- Latino30JUL2020 C4591001 1073 10731009 30 Male 174.2 114.4 37.7 Black or African American Hispanic/Latino 30JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 5 FDA-CBER-2021-5683-0032375 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1073 10731012 51 Male 193 91.3 24.5 White Non-Hispanic/non- Latino30JUL2020 C4591001 1073 10731013 33 Male 180 121.8 37.6 White Hispanic/Latino 30JUL2020 C4591001 1079 10791002 46 Female 162.56 96.82 36.6 White Non-Hispanic/non- Latino29JUL2020 C4591001 1079 10791003 43 Female 168 102 36.1 Black or African American Non-Hispanic/non- Latino29JUL2020 C4591001 1079 10791004 48 Female 154.2 61.05 25.7 White Non-Hispanic/non- Latino29JUL2020 C4591001 1079 10791007 28 Male 171.5 64.5 21.9 White Hispanic/Latino 29JUL2020 C4591001 1079 10791008 38 Female 164 88.1 32.8 White Non-Hispanic/non- Latino29JUL2020 C4591001 1079 10791010 55 Male 178.8 98 30.7 Black or African American Non-Hispanic/non- Latino30JUL2020 C4591001 1079 10791013 25 Female 172.72 84.82 28.4 White Non-Hispanic/non- Latino30JUL2020 C4591001 1082 10821003 32 Male 166.6 58.8 21.2 White Non-Hispanic/non- Latino30JUL2020 C4591001 1082 10821004 27 Female 168.5 93.4 32.9 White Non-Hispanic/non- Latino30JUL2020 C4591001 1083 10831001 20 Male 173.99 108.36 35.7 White Non-Hispanic/non- Latino29JUL2020 C4591001 1083 10831002 26 Male 180.34 73.91 22.7 White Non-Hispanic/non- Latino29JUL2020 C4591001 1083 10831004 54 Female 168.91 78.64 27.5 White Non-Hispanic/non- Latino29JUL2020 C4591001 1083 10831005 44 Female 162.56 88.36 33.4 White Hispanic/Latino 29JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 6 FDA-CBER-2021-5683-0032376 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1083 10831006 28 Female 162.56 68.36 25.8 White Hispanic/Latino 29JUL2020 C4591001 1084 10841001 48 Female 176 87 28.1 White Non-Hispanic/non- Latino30JUL2020 C4591001 1084 10841003 42 Female 168.5 81.9 28.8 White Non-Hispanic/non- Latino30JUL2020 C4591001 1085 10851003 21 Female 168.91 87.27 30.5 White Non-Hispanic/non- Latino30JUL2020 C4591001 1085 10851004 49 Female 154.94 69.18 28.8 White Non-Hispanic/non- Latino30JUL2020 C4591001 1089 10891011 49 Male 199.39 124.64 31.3 White Non-Hispanic/non- Latino30JUL2020 C4591001 1089 10891013 37 Male 185.42 76.36 22.2 White Non-Hispanic/non- Latino30JUL2020 C4591001 1089 10891015 22 Female 168.15 61.45 21.7 White Non-Hispanic/non- Latino30JUL2020 C4591001 1095 10951001 32 Male 180.34 82.3 25.3 White Non-Hispanic/non- Latino30JUL2020 C4591001 1095 10951002 20 Female 157 52 21.1 White Hispanic/Latino 30JUL2020 C4591001 1095 10951005 52 Female 169 63.5 22.2 Asian Non-Hispanic/non- Latino30JUL2020 C4591001 1095 10951006 36 Female 161 64.6 24.9 White Non-Hispanic/non- Latino30JUL2020 C4591001 1095 10951007 49 Male 178 72.6 22.9 White Non-Hispanic/non- Latino30JUL2020 C4591001 1107 11071003 38 Male 181.61 88 26.6 White Non-Hispanic/non- Latino29JUL2020 C4591001 1107 11071006 35 Female 162.56 67.64 25.5 White Non-Hispanic/non- Latino30JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 7 FDA-CBER-2021-5683-0032377 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1107 11071010 21 Female 177.8 105.73 33.4 Black or African American Non-Hispanic/non- Latino30JUL2020 C4591001 1109 11091001 42 Female 160.02 83.82 32.7 White Hispanic/Latino 29JUL2020 C4591001 1109 11091002 49 Male 172.72 111.36 37.2 White Hispanic/Latino 29JUL2020 C4591001 1109 11091003 53 Male 177.8 100 31.6 American Indian or Alaska Native Non-Hispanic/non- Latino29JUL2020 C4591001 1109 11091004 27 Male 172.72 68.18 22.8 White Hispanic/Latino 29JUL2020 C4591001 1109 11091006 50 Female 163.07 78.64 29.5 White Non-Hispanic/non- Latino29JUL2020 C4591001 1109 11091007 55 Female 157.48 73.18 29.4 White Non-Hispanic/non- Latino29JUL2020 C4591001 1109 11091010 39 Female 167.64 69.82 24.8 White Non-Hispanic/non- Latino29JUL2020 C4591001 1109 11091011 32 Male 190.5 79.55 21.9 Black or African American Non-Hispanic/non- Latino29JUL2020 C4591001 1109 11091013 46 Male 173.99 103.5 34.1 White Non-Hispanic/non- Latino29JUL2020 C4591001 1109 11091014 42 Female 152.4 62.45 26.8 White Non-Hispanic/non- Latino29JUL2020 C4591001 1109 11091015 36 Male 177.8 88.64 28 White Non-Hispanic/non- Latino29JUL2020 C4591001 1109 11091016 49 Female 149.86 53.73 23.9 White Non-Hispanic/non- Latino30JUL2020 C4591001 1109 11091017 51 Female 180.34 114.27 35.1 White Non-Hispanic/non- Latino30JUL2020 C4591001 1109 11091018 37 Female 170.18 72.91 25.1 White Non-Hispanic/non- Latino30JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 8 FDA-CBER-2021-5683-0032378 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1109 11091019 47 Male 185.42 100.18 29.1 White Hispanic/Latino 30JUL2020 C4591001 1109 11091020 18 Female 156.21 50 20.4 White Non-Hispanic/non- Latino30JUL2020 C4591001 1109 11091021 52 Female 170.18 59.55 20.5 White Non-Hispanic/non- Latino30JUL2020 C4591001 1109 11091022 50 Female 167.64 83.18 29.5 White Non-Hispanic/non- Latino30JUL2020 C4591001 1109 11091023 55 Male 193.04 108.18 29 Multiracial Non-Hispanic/non- Latino30JUL2020 C4591001 1109 11091024 50 Male 167.64 76.18 27 White Non-Hispanic/non- Latino30JUL2020 C4591001 1109 11091027 46 Female 175.26 65.64 21.3 White Non-Hispanic/non- Latino30JUL2020 C4591001 1109 11091028 40 Male 187.96 94.36 26.7 White Non-Hispanic/non- Latino30JUL2020 C4591001 1109 11091030 25 Male 175.26 72.73 23.6 White Non-Hispanic/non- Latino30JUL2020 C4591001 1109 11091033 44 Male 180.34 109.09 33.5 White Non-Hispanic/non- Latino30JUL2020 C4591001 1111 11111001 19 Male 172.72 63.36 21.2 White Non-Hispanic/non- Latino30JUL2020 C4591001 1112 11121004 44 Female 170.18 93.18 32.1 White Non-Hispanic/non- Latino29JUL2020 C4591001 1112 11121006 26 Female 170.18 93.18 32.1 White Non-Hispanic/non- Latino29JUL2020 C4591001 1112 11121008 38 Female 167.64 86.36 30.7 Black or African American Non-Hispanic/non- Latino29JUL2020 C4591001 1112 11121009 36 Male 175.26 100.18 32.5 Black or African American Non-Hispanic/non- Latino30JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 9 FDA-CBER-2021-5683-0032379 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1112 11121011 32 Male 177.8 68.41 21.6 Multiracial Non-Hispanic/non- Latino30JUL2020 C4591001 1112 11121012 31 Female 175.26 65.45 21.3 White Non-Hispanic/non- Latino30JUL2020 C4591001 1112 11121013 40 Male 185.42 88.64 25.7 White Hispanic/Latino 30JUL2020 C4591001 1112 11121015 53 Male 175.26 80 26 White Non-Hispanic/non- Latino30JUL2020 C4591001 1112 11121016 42 Female 170.18 89.55 30.9 Asian Non-Hispanic/non- Latino30JUL2020 C4591001 1120 11201001 51 Male 180.34 87.73 26.9 White Non-Hispanic/non- Latino29JUL2020 C4591001 1123 11231001 51 Female 163.9 68.8 25.6 White Non-Hispanic/non- Latino29JUL2020 C4591001 1123 11231002 35 Male 185 132.5 38.7 Black or African American Non-Hispanic/non- Latino30JUL2020 C4591001 1123 11231003 41 Male 170 67.9 23.5 White Non-Hispanic/non- Latino30JUL2020 C4591001 1127 11271004 27 Male 177 79.6 25.4 Asian Non-Hispanic/non- Latino29JUL2020 C4591001 1127 11271011 48 Male 183 100.8 30.1 White Non-Hispanic/non- Latino30JUL2020 C4591001 1127 11271014 47 Female 172 69.3 23.4 White Non-Hispanic/non- Latino30JUL2020 C4591001 1127 11271015 55 Male 185 114.6 33.5 White Non-Hispanic/non- Latino30JUL2020 C4591001 1127 11271016 30 Female 167 87.6 31.4 White Non-Hispanic/non- Latino30JUL2020 C4591001 1127 11271017 33 Male 188 132.3 37.4 White Hispanic/Latino 30JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 10 FDA-CBER-2021-5683-0032380 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1129 11291001 36 Male 175.26 129.45 42.1 Black or African American Non-Hispanic/non- Latino29JUL2020 C4591001 1129 11291005 49 Male 170.18 104.36 36 White Non-Hispanic/non- Latino29JUL2020 C4591001 1129 11291006 49 Female 160.02 110 42.9 White Non-Hispanic/non- Latino29JUL2020 C4591001 1129 11291010 45 Male 170.51 85.82 29.5 White Non-Hispanic/non- Latino30JUL2020 C4591001 1129 11291014 43 Male 177.5 71.64 22.7 White Non-Hispanic/non- Latino30JUL2020 C4591001 1133 11331001 49 Male 175 134.4 43.9 White Hispanic/Latino 30JUL2020 C4591001 1133 11331003 49 Female 178 105.7 33.4 White Hispanic/Latino 30JUL2020 C4591001 1133 11331004 31 Male 178 105.7 33.4 White Hispanic/Latino 30JUL2020 C4591001 1133 11331011 54 Female 148 124.1 56.7 White Non-Hispanic/non- Latino30JUL2020 C4591001 1133 11331014 34 Male 180 104.5 32.3 White Non-Hispanic/non- Latino30JUL2020 C4591001 1133 11331016 55 Female 155.5 78.1 32.3 Black or African American Non-Hispanic/non- Latino30JUL2020 C4591001 1139 11391001 39 Female 172.72 73.18 24.5 White Non-Hispanic/non- Latino29JUL2020 C4591001 1139 11391007 43 Female 161.29 52.73 20.2 White Non-Hispanic/non- Latino29JUL2020 C4591001 1139 11391010 40 Male 193.04 108.18 29 White Non-Hispanic/non- Latino29JUL2020 C4591001 1139 11391015 38 Male 183.13 58.68 17.5 White Non-Hispanic/non- Latino30JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 11 FDA-CBER-2021-5683-0032381 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1140 11401001 40 Female White Non-Hispanic/non- Latino29JUL2020 C4591001 1140 11401006 20 Male 178.69 76.45 23.9 White Non-Hispanic/non- Latino30JUL2020 C4591001 1142 11421001 39 Female 173 71.23 23.7 White Hispanic/Latino 29JUL2020 C4591001 1142 11421002 53 Male 172.72 85.91 28.7 White Hispanic/Latino 29JUL2020 C4591001 1142 11421004 39 Female 165.1 69.09 25.3 White Hispanic/Latino 29JUL2020 C4591001 1142 11421007 48 Female 175.26 93.18 30.3 White Hispanic/Latino 29JUL2020 C4591001 1142 11421008 52 Female 175.26 89.09 28.9 White Non-Hispanic/non- Latino29JUL2020 C4591001 1142 11421010 31 Male 185.42 86.36 25.1 White Non-Hispanic/non- Latino30JUL2020 C4591001 1142 11421011 37 Male 170.18 133.86 46.1 White Hispanic/Latino 30JUL2020 C4591001 1142 11421014 50 Male 185.42 77.27 22.4 White Non-Hispanic/non- Latino30JUL2020 C4591001 1142 11421015 48 Female 160.02 91.95 35.8 White Hispanic/Latino 30JUL2020 C4591001 1142 11421016 38 Female 157.48 58.18 23.4 White Hispanic/Latino 30JUL2020 C4591001 1147 11471001 45 Male 177.8 159.27 50.3 Black or African American Not reported 30JUL2020 C4591001 1001 10011083 33 Female 161.9 50.6 19.3 White Non-Hispanic/non- Latino28JUL2020 C4591001 1001 10011105 27 Male 181.7 68.4 20.7 White Non-Hispanic/non- Latino31JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 12 FDA-CBER-2021-5683-0032382 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1001 10011106 44 Male 204.5 115.5 27.6 Black or African American Non-Hispanic/non- Latino31JUL2020 C4591001 1001 10011107 52 Male 180.3 98.2 30.2 White Non-Hispanic/non- Latino31JUL2020 C4591001 1001 10011113 54 Male 180.3 72.6 22.3 White Not reported 03AUG2020 C4591001 1001 10011125 23 Female 156.2 46.8 19.2 White Non-Hispanic/non- Latino04AUG2020 C4591001 1001 10011126 48 Female 163 57.6 21.7 White Non-Hispanic/non- Latino04AUG2020 C4591001 1001 10011129 48 Male 184.2 86.3 25.4 White Non-Hispanic/non- Latino05AUG2020 C4591001 1001 10011130 55 Male 167.6 81 28.8 White Hispanic/Latino 05AUG2020 C4591001 1001 10011131 42 Female 162.6 83.2 31.5 White Non-Hispanic/non- Latino05AUG2020 C4591001 1001 10011132 36 Male 178.4 104.1 32.7 White Non-Hispanic/non- Latino05AUG2020 C4591001 1001 10011135 45 Female 169 56.5 19.8 White Non-Hispanic/non- Latino05AUG2020 C4591001 1001 10011136 53 Female 159 62.4 24.7 White Non-Hispanic/non- Latino06AUG2020 C4591001 1001 10011138 41 Male 176 77 24.9 White Non-Hispanic/non- Latino06AUG2020 C4591001 1001 10011143 33 Male 185.4 88.7 25.8 Black or African American Hispanic/Latino 06AUG2020 C4591001 1001 10011145 31 Female 155.4 65.5 27.1 Black or African American Hispanic/Latino 07AUG2020 C4591001 1001 10011146 38 Male 190.5 89.8 24.7 Black or African American Hispanic/Latino 07AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 13 FDA-CBER-2021-5683-0032383 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1001 10011149 34 Female 167.6 51.3 18.3 White Hispanic/Latino 07AUG2020 C4591001 1003 10031116 42 Female 160.02 67.73 26.4 White Non-Hispanic/non- Latino30JUL2020 C4591001 1003 10031122 48 Male 165.1 102.27 37.4 White Non-Hispanic/non- Latino31JUL2020 C4591001 1003 10031124 23 Female 160.02 51.36 20 White Non-Hispanic/non- Latino31JUL2020 C4591001 1003 10031125 34 Female 165.1 104.55 38.3 White Non-Hispanic/non- Latino31JUL2020 C4591001 1003 10031137 41 Male 180.34 98.64 30.3 White Non-Hispanic/non- Latino04AUG2020 C4591001 1003 10031138 54 Female 160.02 56.36 22 White Non-Hispanic/non- Latino04AUG2020 C4591001 1003 10031141 32 Male 185.42 77.27 22.4 White Non-Hispanic/non- Latino04AUG2020 C4591001 1003 10031144 53 Male 180.34 97.73 30 White Non-Hispanic/non- Latino04AUG2020 C4591001 1003 10031146 39 Male 187.96 84.09 23.8 White Non-Hispanic/non- Latino05AUG2020 C4591001 1003 10031147 38 Female 175.26 92.73 30.1 White Non-Hispanic/non- Latino05AUG2020 C4591001 1003 10031151 55 Male 182.88 81.82 24.4 White Non-Hispanic/non- Latino05AUG2020 C4591001 1003 10031155 31 Male 177.8 127.27 40.2 White Non-Hispanic/non- Latino06AUG2020 C4591001 1003 10031156 51 Female 175.26 84.09 27.3 White Non-Hispanic/non- Latino06AUG2020 C4591001 1003 10031158 50 Male 187.96 95.91 27.1 White Non-Hispanic/non- Latino06AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 14 FDA-CBER-2021-5683-0032384 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1003 10031160 26 Male 170.18 68.18 23.5 Asian Non-Hispanic/non- Latino06AUG2020 C4591001 1003 10031161 55 Female 167.64 129.09 45.8 White Non-Hispanic/non- Latino07AUG2020 C4591001 1003 10031162 55 Female 154.94 76.82 31.9 White Non-Hispanic/non- Latino07AUG2020 C4591001 1003 10031166 51 Male 182.88 136.36 40.7 White Non-Hispanic/non- Latino07AUG2020 C4591001 1003 10031170 33 Female 172.72 72.73 24.3 White Non-Hispanic/non- Latino10AUG2020 C4591001 1003 10031171 38 Male 154.94 59.09 24.6 Asian Non-Hispanic/non- Latino10AUG2020 C4591001 1003 10031174 33 Male 182.88 93.18 27.8 White Non-Hispanic/non- Latino10AUG2020 C4591001 1003 10031175 54 Female 160.02 70.45 27.5 White Non-Hispanic/non- Latino10AUG2020 C4591001 1003 10031177 44 Female 172.72 81.82 27.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1003 10031179 40 Male 172.72 79.55 26.6 White Non-Hispanic/non- Latino11AUG2020 C4591001 1003 10031180 43 Female 154.94 46.82 19.5 White Non-Hispanic/non- Latino11AUG2020 C4591001 1003 10031183 27 Female 167.64 63.64 22.6 White Non-Hispanic/non- Latino11AUG2020 C4591001 1003 10031184 52 Male 180.34 75.45 23.1 White Non-Hispanic/non- Latino11AUG2020 C4591001 1003 10031186 33 Male 182.88 143.18 42.7 White Non-Hispanic/non- Latino12AUG2020 C4591001 1003 10031187 34 Male 175.26 72.73 23.6 White Non-Hispanic/non- Latino12AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 15 FDA-CBER-2021-5683-0032385 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1003 10031190 41 Male 160.02 120.45 46.9 White Non-Hispanic/non- Latino12AUG2020 C4591001 1003 10031191 27 Female 165.1 90.91 33.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1003 10031194 39 Male 172.72 102.27 34.2 White Non-Hispanic/non- Latino13AUG2020 C4591001 1003 10031196 44 Female 152.4 47.73 20.5 White Non-Hispanic/non- Latino13AUG2020 C4591001 1003 10031197 41 Male 182.88 81.82 24.4 White Non-Hispanic/non- Latino13AUG2020 C4591001 1003 10031198 53 Female 152.4 65.91 28.3 White Non-Hispanic/non- Latino13AUG2020 C4591001 1003 10031199 37 Female 160.02 60.45 23.6 White Non-Hispanic/non- Latino13AUG2020 C4591001 1003 10031201 55 Female 165.1 127.27 46.6 White Non-Hispanic/non- Latino13AUG2020 C4591001 1003 10031203 50 Female 170.18 79.55 27.4 White Non-Hispanic/non- Latino14AUG2020 C4591001 1003 10031204 39 Female 160.02 54.55 21.3 White Non-Hispanic/non- Latino14AUG2020 C4591001 1003 10031205 52 Female 162.56 96.36 36.4 Black or African American Non-Hispanic/non- Latino14AUG2020 C4591001 1003 10031206 53 Male 175.26 78.64 25.5 White Non-Hispanic/non- Latino14AUG2020 C4591001 1003 10031207 53 Male 180.34 123.18 37.8 Black or African American Non-Hispanic/non- Latino14AUG2020 C4591001 1005 10051002 51 Female 170.18 83.64 28.8 White Non-Hispanic/non- Latino07AUG2020 C4591001 1005 10051003 26 Male 180.34 78.82 24.2 White Non-Hispanic/non- Latino07AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 16 FDA-CBER-2021-5683-0032386 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1005 10051004 46 Male 186.69 85.91 24.6 White Non-Hispanic/non- Latino10AUG2020 C4591001 1005 10051007 54 Female 157.48 71.73 28.9 White Non-Hispanic/non- Latino10AUG2020 C4591001 1005 10051008 42 Female 161.29 88.05 33.8 White Non-Hispanic/non- Latino10AUG2020 C4591001 1005 10051015 45 Male 177.8 79 24.9 White Non-Hispanic/non- Latino10AUG2020 C4591001 1005 10051016 53 Male 168.91 97.5 34.1 White Non-Hispanic/non- Latino11AUG2020 C4591001 1005 10051017 37 Female 160.02 62.27 24.3 White Non-Hispanic/non- Latino11AUG2020 C4591001 1005 10051024 23 Male 180.34 88.27 27.1 White Non-Hispanic/non- Latino11AUG2020 C4591001 1005 10051026 41 Male 172.72 72.73 24.3 White Non-Hispanic/non- Latino11AUG2020 C4591001 1005 10051027 51 Male 167.64 83.55 29.7 White Non-Hispanic/non- Latino11AUG2020 C4591001 1005 10051028 52 Female 160.02 65.73 25.6 White Non-Hispanic/non- Latino12AUG2020 C4591001 1005 10051029 50 Male 187.96 89.45 25.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1005 10051030 55 Male 179.07 89.09 27.7 White Non-Hispanic/non- Latino12AUG2020 C4591001 1005 10051031 51 Male 185.42 81.55 23.7 White Non-Hispanic/non- Latino12AUG2020 C4591001 1005 10051035 30 Male 172.72 108 36.1 White Non-Hispanic/non- Latino12AUG2020 C4591001 1005 10051036 22 Male 177.8 125.45 39.6 White Non-Hispanic/non- Latino12AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 17 FDA-CBER-2021-5683-0032387 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1005 10051041 45 Female 162.56 101.59 38.4 White Non-Hispanic/non- Latino12AUG2020 C4591001 1005 10051048 39 Female 172.72 71.82 24 White Non-Hispanic/non- Latino13AUG2020 C4591001 1005 10051051 55 Male 170.18 83.18 28.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1005 10051052 25 Male 180.34 67.45 20.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1005 10051054 54 Female 167.64 137.55 48.8 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1005 10051055 33 Female 154.94 84 34.9 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1005 10051057 42 Female 154.94 112.27 46.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1005 10051059 38 Female 162.56 128.64 48.6 White Non-Hispanic/non- Latino13AUG2020 C4591001 1005 10051066 40 Female 162.56 70.45 26.6 White Non-Hispanic/non- Latino13AUG2020 C4591001 1005 10051067 51 Male 179.07 97 30.2 White Non-Hispanic/non- Latino13AUG2020 C4591001 1005 10051070 37 Male 180.34 92.73 28.4 Asian Non-Hispanic/non- Latino14AUG2020 C4591001 1005 10051071 22 Male 182.88 87 26 White Non-Hispanic/non- Latino14AUG2020 C4591001 1005 10051073 44 Male 177.8 95.91 30.3 White Non-Hispanic/non- Latino14AUG2020 C4591001 1005 10051075 30 Female 172.72 107.55 36 Black or African American Non-Hispanic/non- Latino14AUG2020 C4591001 1006 10061005 35 Female 154.94 50 20.8 Asian Non-Hispanic/non- Latino10AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 18 FDA-CBER-2021-5683-0032388 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1006 10061007 35 Female 180.34 110 33.7 White Non-Hispanic/non- Latino10AUG2020 C4591001 1006 10061008 49 Male 171.45 79.18 26.9 White Non-Hispanic/non- Latino10AUG2020 C4591001 1006 10061009 29 Female 163.83 75.55 28.1 White Non-Hispanic/non- Latino10AUG2020 C4591001 1006 10061011 46 Female 165.1 65 23.8 White Non-Hispanic/non- Latino11AUG2020 C4591001 1006 10061012 53 Male 187.96 120.14 33.9 White Non-Hispanic/non- Latino11AUG2020 C4591001 1006 10061013 21 Female 157.48 68.18 27.4 White Non-Hispanic/non- Latino11AUG2020 C4591001 1006 10061014 49 Female 162.56 66.82 25.2 White Non-Hispanic/non- Latino11AUG2020 C4591001 1006 10061015 29 Male 177.8 93.18 29.4 Asian Non-Hispanic/non- Latino11AUG2020 C4591001 1006 10061018 32 Male 172.72 67.82 22.7 White Non-Hispanic/non- Latino11AUG2020 C4591001 1006 10061019 51 Male 182.88 79.55 23.7 White Non-Hispanic/non- Latino12AUG2020 C4591001 1006 10061021 41 Female 157.48 61.91 24.9 White Non-Hispanic/non- Latino12AUG2020 C4591001 1006 10061022 45 Male 187.96 111.36 31.5 White Non-Hispanic/non- Latino12AUG2020 C4591001 1006 10061023 42 Male 177.8 81.82 25.8 White Non-Hispanic/non- Latino12AUG2020 C4591001 1006 10061024 44 Female 162.56 75.64 28.6 White Non-Hispanic/non- Latino12AUG2020 C4591001 1006 10061028 40 Female 153.67 77.27 32.7 White Non-Hispanic/non- Latino13AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 19 FDA-CBER-2021-5683-0032389 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1006 10061031 20 Male 180.34 104.55 32.1 White Non-Hispanic/non- Latino13AUG2020 C4591001 1006 10061032 46 Female 171.45 95.45 32.4 White Non-Hispanic/non- Latino13AUG2020 C4591001 1006 10061033 23 Female 163.83 80.18 29.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1006 10061036 40 Female 172.72 118.82 39.7 White Non-Hispanic/non- Latino14AUG2020 C4591001 1006 10061037 51 Male 193.04 108.64 29.1 White Non-Hispanic/non- Latino14AUG2020 C4591001 1007 10071106 48 Female 167 90.5 32.5 White Non-Hispanic/non- Latino03AUG2020 C4591001 1007 10071107 41 Female 155.5 46.9 19.4 Asian Non-Hispanic/non- Latino03AUG2020 C4591001 1007 10071108 53 Male 177 115.5 36.9 Black or African American Non-Hispanic/non- Latino03AUG2020 C4591001 1007 10071109 36 Male 189.5 86.7 24.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1007 10071110 34 Male 174.5 84.6 27.8 Black or African American Hispanic/Latino 03AUG2020 C4591001 1007 10071111 44 Female 166.2 64.9 23.5 American Indian or Alaska Native Hispanic/Latino 03AUG2020 C4591001 1007 10071112 33 Male 181 100.3 30.6 Black or African American Non-Hispanic/non- Latino03AUG2020 C4591001 1007 10071117 45 Female 173 90.4 30.2 White Non-Hispanic/non- Latino03AUG2020 C4591001 1007 10071118 27 Female 165.8 68.9 25.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1007 10071119 35 Male 189 86.6 24.2 White Non-Hispanic/non- Latino05AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 20 FDA-CBER-2021-5683-0032390 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1007 10071123 24 Female 166 58.3 21.2 White Hispanic/Latino 05AUG2020 C4591001 1007 10071125 53 Male 172.7 96.9 32.5 White Non-Hispanic/non- Latino05AUG2020 C4591001 1007 10071129 54 Male 179.5 79.1 24.5 White Non-Hispanic/non- Latino05AUG2020 C4591001 1007 10071130 36 Male 174 91.1 30.1 Not reported Hispanic/Latino 05AUG2020 C4591001 1007 10071131 25 Male 183 74.5 22.2 Not reported Hispanic/Latino 05AUG2020 C4591001 1007 10071132 42 Male 173 76 25.4 Asian Non-Hispanic/non- Latino05AUG2020 C4591001 1007 10071133 42 Male 178 97 30.6 White Non-Hispanic/non- Latino05AUG2020 C4591001 1007 10071137 45 Male 189 118.3 33.1 White Non-Hispanic/non- Latino06AUG2020 C4591001 1007 10071138 36 Female 172 78.8 26.6 White Non-Hispanic/non- Latino06AUG2020 C4591001 1007 10071143 55 Female 154.3 74.1 31.1 White Non-Hispanic/non- Latino06AUG2020 C4591001 1007 10071145 42 Female 163.5 57.2 21.4 White Non-Hispanic/non- Latino06AUG2020 C4591001 1007 10071146 26 Female 177.8 56.4 17.8 Not reported Non-Hispanic/non- Latino06AUG2020 C4591001 1007 10071148 43 Female 161 90.2 34.8 White Non-Hispanic/non- Latino06AUG2020 C4591001 1007 10071150 36 Male 188.5 107.7 30.3 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1007 10071151 54 Female 152.5 117.4 50.5 Black or African American Non-Hispanic/non- Latino10AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 21 FDA-CBER-2021-5683-0032391 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1007 10071152 46 Female 159 51.2 20.3 White Hispanic/Latino 10AUG2020 C4591001 1007 10071153 38 Female 172.5 108.1 36.3 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1007 10071154 22 Female 165 112.2 41.2 White Non-Hispanic/non- Latino10AUG2020 C4591001 1007 10071155 39 Female 174 73.5 24.3 White Hispanic/Latino 10AUG2020 C4591001 1007 10071157 32 Female 160 52.9 20.7 White Non-Hispanic/non- Latino10AUG2020 C4591001 1007 10071158 38 Male 185.2 126 36.7 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1007 10071159 48 Female 165 125.3 46 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1007 10071162 40 Female 167.7 97.8 34.8 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1007 10071171 40 Female 162.3 63.9 24.3 Black or African American Non-Hispanic/non- Latino12AUG2020 C4591001 1007 10071172 35 Male 171 89.5 30.6 White Non-Hispanic/non- Latino12AUG2020 C4591001 1007 10071175 46 Female 165.5 51 18.6 White Hispanic/Latino 12AUG2020 C4591001 1007 10071178 39 Female 166.5 53.5 19.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1007 10071179 39 Female 171 92.7 31.7 White Non-Hispanic/non- Latino12AUG2020 C4591001 1007 10071181 42 Male 193 94.5 25.4 White Non-Hispanic/non- Latino12AUG2020 C4591001 1007 10071184 53 Male 177 85.6 27.3 White Non-Hispanic/non- Latino13AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 22 FDA-CBER-2021-5683-0032392 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1007 10071185 55 Female 154.5 74.1 31 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1007 10071186 49 Female 166 82 29.8 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1007 10071193 48 Female 160.3 68.3 26.6 White Hispanic/Latino 13AUG2020 C4591001 1007 10071194 53 Female 173.5 83 27.6 Not reported Non-Hispanic/non- Latino13AUG2020 C4591001 1007 10071195 49 Female 160.5 105.5 41 White Hispanic/Latino 13AUG2020 C4591001 1007 10071196 44 Female 170 128.1 44.3 White Non-Hispanic/non- Latino13AUG2020 C4591001 1007 10071197 34 Female 156 48.9 20.1 Not reported Non-Hispanic/non- Latino13AUG2020 C4591001 1008 10081006 26 Male 184.15 98.82 29.1 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1008 10081007 45 Female 171.45 84.91 28.8 White Non-Hispanic/non- Latino10AUG2020 C4591001 1008 10081011 55 Female 165.1 68.73 25.2 White Non-Hispanic/non- Latino11AUG2020 C4591001 1008 10081013 54 Male 172.72 106.73 35.7 White Hispanic/Latino 11AUG2020 C4591001 1008 10081015 33 Male 187.96 71.45 20.2 White Non-Hispanic/non- Latino11AUG2020 C4591001 1008 10081018 36 Male 182.25 105.45 31.7 White Non-Hispanic/non- Latino12AUG2020 C4591001 1008 10081019 31 Female 171.45 70.18 23.8 White Non-Hispanic/non- Latino12AUG2020 C4591001 1008 10081022 39 Male 184.15 85.18 25.1 Asian Non-Hispanic/non- Latino12AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 23 FDA-CBER-2021-5683-0032393 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1008 10081024 48 Female 168.91 84.27 29.5 White Non-Hispanic/non- Latino12AUG2020 C4591001 1008 10081025 50 Male 181.61 132 39.9 White Non-Hispanic/non- Latino13AUG2020 C4591001 1008 10081028 53 Female 151.13 58.45 25.5 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1008 10081029 37 Female 170.18 100 34.5 White Non-Hispanic/non- Latino13AUG2020 C4591001 1008 10081030 45 Female 163.83 82.27 30.6 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1008 10081031 36 Male 190.5 72.82 20 White Non-Hispanic/non- Latino13AUG2020 C4591001 1008 10081033 54 Female 161.29 100.18 38.4 White Non-Hispanic/non- Latino14AUG2020 C4591001 1008 10081036 50 Female 162.56 66.18 25 White Hispanic/Latino 14AUG2020 C4591001 1008 10081037 38 Female 166.37 71.18 25.7 White Non-Hispanic/non- Latino14AUG2020 C4591001 1008 10081040 55 Male 179.71 80 24.7 White Non-Hispanic/non- Latino14AUG2020 C4591001 1009 10091002 47 Male 183.52 106.36 31.5 White Non-Hispanic/non- Latino07AUG2020 C4591001 1009 10091005 31 Male 187.96 97 27.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1009 10091006 50 Female 165.1 64 23.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1009 10091012 45 Male 180.34 88.64 27.2 White Non-Hispanic/non- Latino10AUG2020 C4591001 1009 10091021 53 Female 173.99 68.64 22.6 White Non-Hispanic/non- Latino11AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 24 FDA-CBER-2021-5683-0032394 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1009 10091023 39 Female 172.72 78.09 26.1 White Non-Hispanic/non- Latino11AUG2020 C4591001 1009 10091028 18 Male 190.5 120.73 33.2 White Non-Hispanic/non- Latino12AUG2020 C4591001 1009 10091031 32 Male 180.34 98.64 30.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1009 10091032 52 Female 165.1 80 29.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1009 10091042 38 Male 180.34 98.2 30.1 White Non-Hispanic/non- Latino14AUG2020 C4591001 1009 10091045 45 Male 195.58 99.36 25.9 White Non-Hispanic/non- Latino14AUG2020 C4591001 1009 10091049 37 Male 190.5 108.64 29.9 White Non-Hispanic/non- Latino14AUG2020 C4591001 1009 10091050 50 Female 165.1 100.73 36.9 White Non-Hispanic/non- Latino14AUG2020 C4591001 1011 10111001 45 Female 160.02 74.55 29 White Non-Hispanic/non- Latino11AUG2020 C4591001 1011 10111004 34 Male 175.26 87.55 28.4 White Hispanic/Latino 12AUG2020 C4591001 1011 10111005 24 Male 165.1 92.82 34 Black or African American Hispanic/Latino 12AUG2020 C4591001 1011 10111006 39 Male 175.26 81.64 26.5 Asian Non-Hispanic/non- Latino12AUG2020 C4591001 1011 10111008 47 Female 160.02 88.64 34.5 White Hispanic/Latino 12AUG2020 C4591001 1011 10111009 55 Male 172.72 102.45 34.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1011 10111013 42 Female 161.29 123.73 47.5 White Non-Hispanic/non- Latino12AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 25 FDA-CBER-2021-5683-0032395 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1011 10111016 53 Female 152.4 73.64 31.6 White Non-Hispanic/non- Latino13AUG2020 C4591001 1011 10111017 36 Male 175.26 95.45 31 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1011 10111021 46 Male 187.96 100 28.2 White Hispanic/Latino 13AUG2020 C4591001 1011 10111024 50 Female 154.94 79.64 33.1 White Non-Hispanic/non- Latino13AUG2020 C4591001 1011 10111031 29 Male 180.34 115 35.3 White Non-Hispanic/non- Latino13AUG2020 C4591001 1011 10111032 32 Female 162.56 61.82 23.3 White Non-Hispanic/non- Latino13AUG2020 C4591001 1011 10111034 27 Female 175.26 84.27 27.4 White Non-Hispanic/non- Latino14AUG2020 C4591001 1011 10111035 47 Female 182.88 59.91 17.9 White Non-Hispanic/non- Latino14AUG2020 C4591001 1011 10111038 48 Male 187.96 79.55 22.5 White Non-Hispanic/non- Latino14AUG2020 C4591001 1011 10111039 40 Female 157.48 129.55 52.1 White Non-Hispanic/non- Latino14AUG2020 C4591001 1012 10121001 41 Male 185.42 146.36 42.5 White Hispanic/Latino 03AUG2020 C4591001 1012 10121003 51 Female 154.94 76.36 31.7 White Hispanic/Latino 03AUG2020 C4591001 1012 10121005 42 Female 160.02 66.36 25.9 White Non-Hispanic/non- Latino03AUG2020 C4591001 1012 10121006 52 Male 175.26 74.09 24.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1012 10121013 50 Male 180.34 123.64 37.9 White Hispanic/Latino 05AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 26 FDA-CBER-2021-5683-0032396 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1012 10121014 54 Male 175.26 99.09 32.2 White Non-Hispanic/non- Latino05AUG2020 C4591001 1012 10121016 55 Male 180.34 101.82 31.2 White Non-Hispanic/non- Latino06AUG2020 C4591001 1012 10121020 49 Male 180.34 93.64 28.7 White Non-Hispanic/non- Latino07AUG2020 C4591001 1012 10121021 43 Female 170.18 71.36 24.6 White Non-Hispanic/non- Latino07AUG2020 C4591001 1012 10121022 38 Male 175.26 75.45 24.5 White Hispanic/Latino 10AUG2020 C4591001 1012 10121024 52 Male 177.8 87.73 27.7 White Non-Hispanic/non- Latino10AUG2020 C4591001 1012 10121025 55 Male 180.34 82.73 25.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1012 10121027 30 Male 177.8 109.09 34.4 White Hispanic/Latino 11AUG2020 C4591001 1012 10121030 42 Male 172.72 90.91 30.4 White Hispanic/Latino 12AUG2020 C4591001 1012 10121032 54 Male 182.88 82.73 24.7 White Non-Hispanic/non- Latino12AUG2020 C4591001 1012 10121036 39 Female 162.56 88.18 33.3 White Non-Hispanic/non- Latino14AUG2020 C4591001 1012 10121037 44 Female 162.56 65 24.5 White Hispanic/Latino 14AUG2020 C4591001 1013 10131033 31 Female 162.6 63.6 24.1 White Non-Hispanic/non- Latino31JUL2020 C4591001 1013 10131034 45 Male 171.1 64.4 22 Asian Non-Hispanic/non- Latino31JUL2020 C4591001 1013 10131035 47 Female 163.9 71.8 26.7 White Non-Hispanic/non- Latino31JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 27 FDA-CBER-2021-5683-0032397 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1013 10131036 47 Female 162.6 70 26.5 White Hispanic/Latino 31JUL2020 C4591001 1013 10131038 53 Female 156.5 63.2 25.8 Asian Non-Hispanic/non- Latino31JUL2020 C4591001 1013 10131039 29 Female 170.8 63.1 21.6 White Hispanic/Latino 31JUL2020 C4591001 1013 10131040 28 Female 170.8 51.3 17.6 White Non-Hispanic/non- Latino31JUL2020 C4591001 1013 10131042 52 Male 182.8 111.4 33.3 Black or African American Non-Hispanic/non- Latino31JUL2020 C4591001 1013 10131044 51 Male 183.1 85.3 25.4 Black or African American Non-Hispanic/non- Latino31JUL2020 C4591001 1013 10131045 53 Female 171.5 81.2 27.6 Black or African American Non-Hispanic/non- Latino31JUL2020 C4591001 1013 10131046 49 Male 172.7 67.1 22.5 White Hispanic/Latino 31JUL2020 C4591001 1013 10131047 40 Female 174.1 77.6 25.6 Black or African American Non-Hispanic/non- Latino31JUL2020 C4591001 1013 10131048 37 Female 167.6 63.5 22.6 Multiracial Non-Hispanic/non- Latino31JUL2020 C4591001 1013 10131049 53 Male 176 56 18.1 Black or African American Non-Hispanic/non- Latino31JUL2020 C4591001 1013 10131050 54 Female 153.7 48.6 20.6 White Non-Hispanic/non- Latino31JUL2020 C4591001 1013 10131051 33 Female 180.1 70.4 21.7 White Non-Hispanic/non- Latino03AUG2020 C4591001 1013 10131052 30 Male 184 103.2 30.5 Asian Non-Hispanic/non- Latino03AUG2020 C4591001 1013 10131054 36 Male 189.5 100.8 28.1 White Non-Hispanic/non- Latino03AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 28 FDA-CBER-2021-5683-0032398 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1013 10131055 40 Male 170.1 81.2 28.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1013 10131056 40 Female 170.2 117.9 40.7 White Non-Hispanic/non- Latino03AUG2020 C4591001 1013 10131057 29 Female 162.2 81.8 31.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1013 10131058 43 Male 172 67.6 22.9 Black or African American Non-Hispanic/non- Latino03AUG2020 C4591001 1013 10131059 24 Female 161.5 43.7 16.8 White Non-Hispanic/non- Latino03AUG2020 C4591001 1013 10131060 23 Male 187 75.4 21.6 White Hispanic/Latino 03AUG2020 C4591001 1013 10131062 49 Male 188.7 97.1 27.3 White Non-Hispanic/non- Latino04AUG2020 C4591001 1013 10131063 47 Male 182 83.4 25.2 White Non-Hispanic/non- Latino04AUG2020 C4591001 1013 10131064 28 Female 179.8 104.1 32.2 White Non-Hispanic/non- Latino04AUG2020 C4591001 1013 10131066 48 Female 162.5 69.5 26.3 White Non-Hispanic/non- Latino04AUG2020 C4591001 1013 10131067 29 Female 167.8 91.1 32.4 White Non-Hispanic/non- Latino04AUG2020 C4591001 1013 10131068 38 Female 163.3 92.5 34.7 White Non-Hispanic/non- Latino04AUG2020 C4591001 1013 10131071 55 Male 180.18 101 31.1 Multiracial Non-Hispanic/non- Latino04AUG2020 C4591001 1013 10131072 50 Female 171.1 78.8 26.9 White Non-Hispanic/non- Latino04AUG2020 C4591001 1013 10131074 40 Female 169.1 63.6 22.2 White Non-Hispanic/non- Latino04AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 29 FDA-CBER-2021-5683-0032399 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1013 10131076 40 Female 172.7 91.8 30.8 White Non-Hispanic/non- Latino04AUG2020 C4591001 1013 10131077 25 Male 172.5 112.8 37.9 White Hispanic/Latino 04AUG2020 C4591001 1013 10131078 37 Male 180.3 78.6 24.2 White Non-Hispanic/non- Latino04AUG2020 C4591001 1013 10131079 36 Male 179.9 99.1 30.6 White Non-Hispanic/non- Latino04AUG2020 C4591001 1013 10131081 39 Male 177.5 67.2 21.3 White Non-Hispanic/non- Latino05AUG2020 C4591001 1013 10131082 41 Female 169.6 82.5 28.7 White Non-Hispanic/non- Latino05AUG2020 C4591001 1013 10131083 54 Male 176.2 94.7 30.5 White Hispanic/Latino 05AUG2020 C4591001 1013 10131084 49 Female 157 57.6 23.4 White Hispanic/Latino 05AUG2020 C4591001 1013 10131087 44 Male 177 85.1 27.2 White Hispanic/Latino 05AUG2020 C4591001 1013 10131089 29 Female 153.4 52.5 22.3 White Non-Hispanic/non- Latino06AUG2020 C4591001 1013 10131090 45 Female 159 74 29.3 White Non-Hispanic/non- Latino06AUG2020 C4591001 1013 10131093 54 Female 152.9 64.6 27.6 White Hispanic/Latino 06AUG2020 C4591001 1013 10131094 43 Male 176 81.7 26.4 White Non-Hispanic/non- Latino06AUG2020 C4591001 1013 10131098 55 Male 179 98.6 30.8 Black or African Ame rican Non-Hispanic/non- Latino06AUG2020 C4591001 1013 10131102 39 Male 187.9 100 28.3 White Hispanic/Latino 06AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 30 FDA-CBER-2021-5683-0032400 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1013 10131103 43 Male 182 80 24.2 White Hispanic/Latino 06AUG2020 C4591001 1013 10131105 50 Male 176 83.1 26.8 White Non-Hispanic/non- Latino10AUG2020 C4591001 1013 10131106 48 Male 175.2 81.8 26.6 White Non-Hispanic/non- Latino10AUG2020 C4591001 1013 10131107 45 Male 177.8 77.3 24.5 White Non-Hispanic/non- Latino10AUG2020 C4591001 1013 10131108 36 Male 175.3 77.3 25.2 White Non-Hispanic/non- Latino10AUG2020 C4591001 1013 10131109 42 Female 165.1 60.4 22.2 White Non-Hispanic/non- Latino10AUG2020 C4591001 1013 10131111 40 Male 185.4 75.6 22 White Non-Hispanic/non- Latino10AUG2020 C4591001 1013 10131113 29 Male 185.5 76 22.1 White Non-Hispanic/non- Latino10AUG2020 C4591001 1013 10131115 55 Male 168.9 100 35.1 White Hispanic/Latino 10AUG2020 C4591001 1013 10131116 49 Male 176.1 102.6 33.1 Asian Non-Hispanic/non- Latino10AUG2020 C4591001 1013 10131117 39 Male 185.4 86.3 25.1 White Non-Hispanic/non- Latino10AUG2020 C4591001 1013 10131118 27 Male 176.9 79.2 25.3 Asian Non-Hispanic/non- Latino10AUG2020 C4591001 1013 10131119 44 Female 162.5 61.4 23.3 White Hispanic/Latino 10AUG2020 C4591001 1013 10131120 34 Male 177.6 66.7 21.1 White Non-Hispanic/non- Latino10AUG2020 C4591001 1013 10131121 23 Female 168 64 22.7 White Non-Hispanic/non- Latino10AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 31 FDA-CBER-2021-5683-0032401 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1013 10131122 34 Male 183.8 86.8 25.7 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1013 10131124 41 Male 165.4 88.5 32.3 White Non-Hispanic/non- Latino11AUG2020 C4591001 1013 10131125 36 Male 187.9 136 38.5 White Non-Hispanic/non- Latino11AUG2020 C4591001 1013 10131126 51 Female 160 63.6 24.8 Asian Non-Hispanic/non- Latino11AUG2020 C4591001 1013 10131127 41 Female 162.6 56.5 21.4 White Non-Hispanic/non- Latino11AUG2020 C4591001 1013 10131128 51 Female 157.4 122.4 49.4 White Non-Hispanic/non- Latino11AUG2020 C4591001 1013 10131131 41 Female 168.1 80 28.3 Native Hawaiian or other Pacific Islande r Non-Hispanic/non- Latino11AUG2020 C4591001 1013 10131132 41 Male 172.5 86 28.9 White Non-Hispanic/non- Latino11AUG2020 C4591001 1013 10131135 43 Male 170.2 60.4 20.9 White Non-Hispanic/non- Latino11AUG2020 C4591001 1013 10131136 41 Male 189 132.4 37.1 White Non-Hispanic/non- Latino11AUG2020 C4591001 1013 10131137 51 Male 181 109.6 33.5 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1013 10131138 55 Male 175.3 63.6 20.7 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1013 10131139 27 Male 178.1 116.1 36.6 White Non-Hispanic/non- Latino11AUG2020 C4591001 1013 10131143 45 Male 172.7 63.5 21.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1013 10131145 26 Female 172.7 113.6 38.1 White Non-Hispanic/non- Latino12AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 32 FDA-CBER-2021-5683-0032402 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1013 10131146 27 Male 172.7 81.8 27.4 White Non-Hispanic/non- Latino12AUG2020 C4591001 1013 10131147 26 Female 160 54.5 21.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1013 10131148 46 Female 165 97.7 35.9 White Non-Hispanic/non- Latino12AUG2020 C4591001 1013 10131149 36 Male 175.4 83.1 27 White Non-Hispanic/non- Latino12AUG2020 C4591001 1013 10131155 54 Female 154.1 65.2 27.5 White Non-Hispanic/non- Latino12AUG2020 C4591001 1013 10131156 31 Female 167.6 68 24.2 White Non-Hispanic/non- Latino12AUG2020 C4591001 1013 10131158 31 Female 170.6 71.7 24.6 White Non-Hispanic/non- Latino12AUG2020 C4591001 1013 10131159 40 Male 170.2 68.8 23.8 Asian Non-Hispanic/non- Latino12AUG2020 C4591001 1013 10131163 42 Female 155.6 68.7 28.4 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1013 10131165 28 Male 183 86 25.7 White Hispanic/Latino 13AUG2020 C4591001 1013 10131166 50 Male 160.5 81.4 31.6 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1013 10131167 50 Female 157.2 81.5 33 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1013 10131169 26 Female 165 55 20.2 White Hispanic/Latino 13AUG2020 C4591001 1013 10131171 21 Female 160 68 26.6 White Hispanic/Latino 13AUG2020 C4591001 1013 10131172 27 Male 185 124 36.2 White Non-Hispanic/non- Latino13AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 33 FDA-CBER-2021-5683-0032403 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1013 10131173 39 Female 179.2 114.8 35.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1013 10131174 20 Female 165.1 86.2 31.6 White Non-Hispanic/non- Latino13AUG2020 C4591001 1013 10131177 54 Male 180.6 100.7 30.9 White Non-Hispanic/non- Latino13AUG2020 C4591001 1013 10131179 36 Male 177.8 84.1 26.6 White Non-Hispanic/non- Latino13AUG2020 C4591001 1013 10131180 39 Female 160 78.6 30.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1013 10131182 51 Female 170 71 24.6 White Non-Hispanic/non- Latino13AUG2020 C4591001 1013 10131185 36 Male 179.8 78.1 24.2 White Hispanic/Latino 13AUG2020 C4591001 1015 10151001 35 Male 177.8 63.91 20.2 White Non-Hispanic/non- Latino10AUG2020 C4591001 1015 10151005 27 Male 180.34 81.82 25.1 White Non-Hispanic/non- Latino12AUG2020 C4591001 1015 10151006 24 Female 176.53 67.18 21.5 White Non-Hispanic/non- Latino12AUG2020 C4591001 1015 10151009 26 Female 160.02 54.55 21.3 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1015 10151010 52 Male 182.88 84.09 25.1 Multiracial Non-Hispanic/non- Latino13AUG2020 C4591001 1015 10151011 30 Male 190.5 93.18 25.6 White Non-Hispanic/non- Latino13AUG2020 C4591001 1015 10151013 32 Male 175.26 102.27 33.2 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1015 10151014 29 Female 167.64 50 17.8 White Non-Hispanic/non- Latino13AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 34 FDA-CBER-2021-5683-0032404 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1015 10151015 43 Female 172.72 67.73 22.7 White Non-Hispanic/non- Latino14AUG2020 C4591001 1015 10151017 26 Male 170.18 56.82 19.6 White Non-Hispanic/non- Latino14AUG2020 C4591001 1015 10151018 33 Female 172.72 70.45 23.6 White Non-Hispanic/non- Latino14AUG2020 C4591001 1015 10151021 35 Female 168.91 66.82 23.4 White Hispanic/Latino 14AUG2020 C4591001 1015 10151023 50 Male 180.34 81.36 25 White Non-Hispanic/non- Latino14AUG2020 C4591001 1015 10151026 43 Male 182.88 65.91 19.7 White Non-Hispanic/non- Latino15AUG2020 C4591001 1015 10151027 42 Female 162.56 56.82 21.5 Not reported Not reported 15AUG2020 C4591001 1016 10161017 18 Female 165.1 66.18 24.2 White Non-Hispanic/non- Latino31JUL2020 C4591001 1016 10161018 48 Female 154.94 57.09 23.7 White Non-Hispanic/non- Latino31JUL2020 C4591001 1016 10161019 46 Female 167.64 87.27 31 White Non-Hispanic/non- Latino31JUL2020 C4591001 1016 10161020 44 Female 151.13 57.91 25.3 White Non-Hispanic/non- Latino31JUL2020 C4591001 1016 10161021 40 Female 161.29 59 22.6 White Non-Hispanic/non- Latino31JUL2020 C4591001 1016 10161028 25 Male 180.34 115.45 35.4 White Non-Hispanic/non- Latino03AUG2020 C4591001 1016 10161029 29 Male 177.8 124.09 39.2 White Non-Hispanic/non- Latino03AUG2020 C4591001 1016 10161030 37 Male 170.69 60 20.5 White Non-Hispanic/non- Latino03AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 35 FDA-CBER-2021-5683-0032405 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1016 10161031 51 Female 162.56 85.45 32.3 Black or African American Non-Hispanic/non- Latino03AUG2020 C4591001 1016 10161038 38 Female 160.02 118.55 46.2 Black or African American Non-Hispanic/non- Latino04AUG2020 C4591001 1016 10161043 26 Female 165.74 113.18 41.1 White Non-Hispanic/non- Latino04AUG2020 C4591001 1016 10161045 45 Female 163.83 79 29.4 White Non-Hispanic/non- Latino04AUG2020 C4591001 1016 10161046 34 Female 165.61 154.45 56.2 White Non-Hispanic/non- Latino04AUG2020 C4591001 1016 10161047 20 Female 165.1 72.64 26.6 White Non-Hispanic/non- Latino04AUG2020 C4591001 1016 10161048 52 Female 165.1 92.18 33.7 White Non-Hispanic/non- Latino04AUG2020 C4591001 1016 10161049 38 Female 167.64 103 36.6 Black or African American Non-Hispanic/non- Latino04AUG2020 C4591001 1016 10161051 41 Female 143.51 87.45 42.4 Black or African American Non-Hispanic/non- Latino05AUG2020 C4591001 1016 10161054 43 Male 170.18 127.73 44 White Non-Hispanic/non- Latino05AUG2020 C4591001 1016 10161057 40 Female 165.1 87 31.8 White Non-Hispanic/non- Latino05AUG2020 C4591001 1016 10161058 24 Female 167.64 65.82 23.4 Black or African American Non-Hispanic/non- Latino05AUG2020 C4591001 1016 10161060 49 Male 168.91 111.91 39.1 White Non-Hispanic/non- Latino06AUG2020 C4591001 1016 10161064 54 Female 170.18 70.91 24.4 White Non-Hispanic/non- Latino06AUG2020 C4591001 1016 10161065 43 Female 162.56 62.82 23.7 White Non-Hispanic/non- Latino06AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 36 FDA-CBER-2021-5683-0032406 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1016 10161069 32 Female 162.56 85.64 32.3 Black or African American Non-Hispanic/non- Latino06AUG2020 C4591001 1016 10161071 39 Female 175.26 96.82 31.5 White Non-Hispanic/non- Latino06AUG2020 C4591001 1016 10161073 50 Female 175.26 113.18 36.8 White Non-Hispanic/non- Latino06AUG2020 C4591001 1016 10161076 45 Male 190.5 138.27 38 White Non-Hispanic/non- Latino06AUG2020 C4591001 1016 10161077 35 Female 142.24 76.55 37.8 White Non-Hispanic/non- Latino07AUG2020 C4591001 1016 10161078 31 Female 149.86 63.09 28 White Non-Hispanic/non- Latino07AUG2020 C4591001 1016 10161080 34 Female 161.29 101.27 38.8 White Non-Hispanic/non- Latino07AUG2020 C4591001 1016 10161081 50 Female 175.26 72 23.4 White Non-Hispanic/non- Latino07AUG2020 C4591001 1016 10161082 38 Female 175.26 88.64 28.8 White Non-Hispanic/non- Latino07AUG2020 C4591001 1016 10161084 38 Female 172.72 100.45 33.6 White Not reported 07AUG2020 C4591001 1016 10161085 45 Female 169.67 80.64 27.9 White Non-Hispanic/non- Latino10AUG2020 C4591001 1016 10161087 43 Female 177.8 77.32 24.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1016 10161091 30 Female 162.56 141.27 53.3 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1016 10161092 32 Female 175.26 105.91 34.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1016 10161093 45 Female 168.91 57.18 20 White Non-Hispanic/non- Latino11AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 37 FDA-CBER-2021-5683-0032407 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1016 10161094 36 Male 194.31 130.45 34.5 American Indian or Alaska Native Hispanic/Latino 11AUG2020 C4591001 1016 10161095 47 Female 165.1 62.18 22.8 White Non-Hispanic/non- Latino11AUG2020 C4591001 1016 10161097 38 Female 170.18 86.73 29.9 White Non-Hispanic/non- Latino11AUG2020 C4591001 1016 10161101 29 Female 173.99 110 36.3 White Non-Hispanic/non- Latino11AUG2020 C4591001 1016 10161102 34 Female 162.56 151.73 57.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1016 10161103 29 Female 162.56 110.91 41.9 White Non-Hispanic/non- Latino12AUG2020 C4591001 1016 10161105 39 Female 156.21 71.82 29.4 White Non-Hispanic/non- Latino12AUG2020 C4591001 1016 10161106 42 Female 167.64 90.91 32.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1016 10161107 45 Male 190.5 116.82 32.1 White Non-Hispanic/non- Latino12AUG2020 C4591001 1016 10161109 35 Male 167.64 114.18 40.5 White Non-Hispanic/non- Latino12AUG2020 C4591001 1016 10161114 22 Female 165.1 93.09 34.1 White Non-Hispanic/non- Latino13AUG2020 C4591001 1016 10161117 26 Male 172.72 83.91 28.1 White Non-Hispanic/non- Latino13AUG2020 C4591001 1016 10161118 34 Female 162.56 73.91 27.9 White Non-Hispanic/non- Latino13AUG2020 C4591001 1016 10161119 45 Female 177.8 105.55 33.3 Black or African American Non-Hispanic/non- Latino14AUG2020 C4591001 1016 10161120 27 Female 165.1 74.18 27.2 White Non-Hispanic/non- Latino14AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 38 FDA-CBER-2021-5683-0032408 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1016 10161122 29 Female 162.56 146.73 55.4 White Non-Hispanic/non- Latino14AUG2020 C4591001 1016 10161123 48 Female 167.64 63.86 22.7 White Non-Hispanic/non- Latino14AUG2020 C4591001 1016 10161125 18 Female 167.64 65.55 23.3 White Non-Hispanic/non- Latino14AUG2020 C4591001 1018 10181009 45 Female 171.45 73.36 24.9 White Non-Hispanic/non- Latino30JUL2020 C4591001 1018 10181010 49 Male 177.8 93.18 29.4 White Non-Hispanic/non- Latino30JUL2020 C4591001 1018 10181011 37 Male 182.88 113.09 33.7 White Non-Hispanic/non- Latino30JUL2020 C4591001 1018 10181012 36 Male 180.34 86.73 26.6 Black or African American Non-Hispanic/non- Latino30JUL2020 C4591001 1018 10181013 40 Male 187.96 88.18 24.9 White Non-Hispanic/non- Latino30JUL2020 C4591001 1018 10181014 40 Male 182.88 81.18 24.2 Black or African American Non-Hispanic/non- Latino30JUL2020 C4591001 1018 10181015 24 Male 162.56 62.55 23.6 White Hispanic/Latino 31JUL2020 C4591001 1018 10181016 47 Female 157.48 76.45 30.8 White Hispanic/Latino 31JUL2020 C4591001 1018 10181017 39 Female 160.02 74.09 28.9 Asian Non-Hispanic/non- Latino31JUL2020 C4591001 1018 10181018 34 Female 152.4 83.36 35.8 White Hispanic/Latino 31JUL2020 C4591001 1018 10181019 44 Male 182.88 70.82 21.1 White Hispanic/Latino 31JUL2020 C4591001 1018 10181020 42 Female 156.21 65.45 26.8 White Non-Hispanic/non- Latino31JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 39 FDA-CBER-2021-5683-0032409 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1018 10181021 34 Female 160.02 99.91 38.9 White Hispanic/Latino 31JUL2020 C4591001 1018 10181022 25 Male 173.99 106.18 35 White Hispanic/Latino 31JUL2020 C4591001 1018 10181024 38 Female 170.18 86.55 29.8 White Non-Hispanic/non- Latino03AUG2020 C4591001 1018 10181025 29 Female 177.8 104.45 33 Black or African American Non-Hispanic/non- Latino03AUG2020 C4591001 1018 10181026 27 Male 182.88 61.36 18.3 Asian Non-Hispanic/non- Latino03AUG2020 C4591001 1018 10181027 32 Female 160.02 70.18 27.3 White Hispanic/Latino 03AUG2020 C4591001 1018 10181028 39 Female 175.26 93.55 30.4 White Hispanic/Latino 03AUG2020 C4591001 1018 10181029 48 Female 170.82 71.55 24.5 White Non-Hispanic/non- Latino03AUG2020 C4591001 1018 10181030 31 Male 172.72 67.45 22.6 White Non-Hispanic/non- Latino03AUG2020 C4591001 1018 10181031 35 Male 177.8 78.82 24.9 White Hispanic/Latino 03AUG2020 C4591001 1018 10181032 24 Female 167.64 94.55 33.6 White Hispanic/Latino 03AUG2020 C4591001 1018 10181033 30 Female 175.26 59.09 19.2 Asian Non-Hispanic/non- Latino03AUG2020 C4591001 1018 10181034 31 Male 162.56 74.55 28.1 White Hispanic/Latino 03AUG2020 C4591001 1018 10181036 29 Male 170.18 106 36.5 White Hispanic/Latino 03AUG2020 C4591001 1018 10181037 41 Male 175.26 111.45 36.2 White Non-Hispanic/non- Latino03AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 40 FDA-CBER-2021-5683-0032410 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1018 10181038 50 Male 180.85 134.18 40.9 White Non-Hispanic/non- Latino03AUG2020 C4591001 1018 10181039 35 Male 180.34 72.18 22.1 White Hispanic/Latino 03AUG2020 C4591001 1018 10181040 41 Female 165.1 52.73 19.3 White Hispanic/Latino 03AUG2020 C4591001 1018 10181042 23 Male 179.07 87.09 27.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1018 10181045 26 Female 161.29 57.91 22.2 Asian Non-Hispanic/non- Latino03AUG2020 C4591001 1018 10181046 24 Female 170.18 79.55 27.4 White Hispanic/Latino 03AUG2020 C4591001 1018 10181047 30 Male 177.8 92.64 29.2 White Non-Hispanic/non- Latino04AUG2020 C4591001 1018 10181048 42 Male 171.45 71.27 24.2 White Hispanic/Latino 04AUG2020 C4591001 1018 10181049 34 Male 183.52 85.45 25.3 White Non-Hispanic/non- Latino04AUG2020 C4591001 1018 10181050 51 Female 162.56 63.91 24.1 White Non-Hispanic/non- Latino04AUG2020 C4591001 1018 10181051 36 Male 170.18 63.73 22 White Hispanic/Latino 04AUG2020 C4591001 1018 10181052 29 Female 162.31 101.09 38.3 White Hispanic/Latino 04AUG2020 C4591001 1018 10181053 33 Male 163.83 97.09 36.1 White Hispanic/Latino 04AUG2020 C4591001 1018 10181054 21 Male 170.18 83 28.6 Asian Non-Hispanic/non- Latino04AUG2020 C4591001 1018 10181055 45 Female 165.1 65.55 24 White Hispanic/Latino 04AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 41 FDA-CBER-2021-5683-0032411 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1018 10181056 41 Female 166.37 105.36 38 White Hispanic/Latino 04AUG2020 C4591001 1018 10181057 35 Male 172.72 81.73 27.3 Asian Non-Hispanic/non- Latino04AUG2020 C4591001 1018 10181058 33 Female 160.02 61.09 23.8 White Hispanic/Latino 04AUG2020 C4591001 1018 10181059 49 Female 167.64 87.73 31.1 Black or African American Non-Hispanic/non- Latino04AUG2020 C4591001 1018 10181062 33 Male 168.91 93.45 32.7 White Hispanic/Latino 05AUG2020 C4591001 1018 10181064 54 Female 157.48 71.55 28.8 White Non-Hispanic/non- Latino05AUG2020 C4591001 1018 10181066 42 Female 175.26 82.91 26.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1018 10181067 36 Female 162.56 71.36 26.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1018 10181071 39 Female 162.56 84.55 31.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1018 10181072 40 Male 180.34 104.55 32.1 Black or African American Non-Hispanic/non- Latino05AUG2020 C4591001 1018 10181074 30 Male 172.72 73.45 24.6 White Non-Hispanic/non- Latino05AUG2020 C4591001 1018 10181076 35 Male 175.26 70 22.7 White Hispanic/Latino 05AUG2020 C4591001 1018 10181077 52 Male 149.86 92.64 41.2 White Non-Hispanic/non- Latino05AUG2020 C4591001 1018 10181079 30 Female 154.94 75.64 31.4 White Non-Hispanic/non- Latino05AUG2020 C4591001 1018 10181081 52 Female 167.64 57.73 20.5 White Non-Hispanic/non- Latino05AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 42 FDA-CBER-2021-5683-0032412 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1018 10181083 45 Male 180.34 104.55 32.1 White Non-Hispanic/non- Latino06AUG2020 C4591001 1018 10181084 44 Female 162.56 65 24.5 White Non-Hispanic/non- Latino06AUG2020 C4591001 1018 10181085 34 Male 175.26 70 22.7 White Non-Hispanic/non- Latino06AUG2020 C4591001 1018 10181086 26 Male 187.96 79.55 22.5 White Non-Hispanic/non- Latino06AUG2020 C4591001 1018 10181088 53 Male 182.88 95.45 28.5 White Non-Hispanic/non- Latino06AUG2020 C4591001 1018 10181089 28 Female 160.02 61.09 23.8 White Hispanic/Latino 06AUG2020 C4591001 1018 10181090 31 Male 180.34 80.45 24.7 White Hispanic/Latino 06AUG2020 C4591001 1018 10181091 24 Male 165.1 109.55 40.1 American Indian or Alaska Native Hispanic/Latino 06AUG2020 C4591001 1018 10181093 43 Male 177.8 90.91 28.7 White Non-Hispanic/non- Latino06AUG2020 C4591001 1018 10181094 43 Male 187.33 112.18 31.9 White Non-Hispanic/non- Latino06AUG2020 C4591001 1018 10181095 26 Male 191.77 92.82 25.2 White Non-Hispanic/non- Latino06AUG2020 C4591001 1018 10181098 31 Male 175.26 117.45 38.2 White Hispanic/Latino 07AUG2020 C4591001 1018 10181100 26 Male 172.72 98.89 33.1 Asian Non-Hispanic/non- Latino07AUG2020 C4591001 1018 10181103 46 Female 163.2 105 39.3 White Hispanic/Latino 07AUG2020 C4591001 1018 10181104 45 Female 162.56 82.82 31.3 Native Hawaiian or other Pacific Islande r Non-Hispanic/non- Latino07AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 43 FDA-CBER-2021-5683-0032413 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1018 10181105 28 Female 162.56 59.09 22.3 White Non-Hispanic/non- Latino07AUG2020 C4591001 1018 10181106 55 Female 166.37 62.73 22.6 White Hispanic/Latino 07AUG2020 C4591001 1018 10181107 26 Female 160.02 77 30 White Hispanic/Latino 10AUG2020 C4591001 1018 10181108 27 Male 172.72 64.09 21.4 Asian Non-Hispanic/non- Latino10AUG2020 C4591001 1018 10181109 49 Male 177.8 106.82 33.7 White Hispanic/Latino 10AUG2020 C4591001 1018 10181111 36 Female 162.56 86.09 32.5 White Hispanic/Latino 10AUG2020 C4591001 1018 10181113 29 Female 167.64 103.64 36.8 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1018 10181114 45 Female 154.94 63.55 26.4 Asian Non-Hispanic/non- Latino10AUG2020 C4591001 1018 10181116 46 Female 160.02 69.55 27.1 White Non-Hispanic/non- Latino10AUG2020 C4591001 1018 10181118 37 Female 170.18 68.64 23.6 White Non-Hispanic/non- Latino10AUG2020 C4591001 1018 10181119 34 Male 179.07 84.09 26.2 White Non-Hispanic/non- Latino10AUG2020 C4591001 1018 10181120 48 Female 157.48 63.86 25.7 White Non-Hispanic/non- Latino10AUG2020 C4591001 1018 10181125 35 Male 180.34 95.18 29.2 White Non-Hispanic/non- Latino11AUG2020 C4591001 1018 10181126 25 Male 180.34 90.91 27.9 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1018 10181127 27 Male 175.26 81.09 26.3 Asian Non-Hispanic/non- Latino12AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 44 FDA-CBER-2021-5683-0032414 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1018 10181128 49 Male 172.72 74.18 24.8 White Hispanic/Latino 12AUG2020 C4591001 1018 10181131 27 Male 172.72 79.55 26.6 White Hispanic/Latino 12AUG2020 C4591001 1018 10181133 22 Female 167.64 54.77 19.4 White Hispanic/Latino 12AUG2020 C4591001 1018 10181139 53 Female 157.48 64.55 26 Asian Non-Hispanic/non- Latino12AUG2020 C4591001 1018 10181141 37 Female 160.02 65.27 25.4 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1018 10181142 38 Female 162.56 72.73 27.5 Asian Non-Hispanic/non- Latino12AUG2020 C4591001 1018 10181143 49 Female 160.02 77.27 30.1 White Hispanic/Latino 12AUG2020 C4591001 1018 10181144 30 Male 189.23 146.73 40.9 White Hispanic/Latino 13AUG2020 C4591001 1018 10181145 31 Female 156.21 51.64 21.1 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1018 10181146 44 Male 185.42 97.73 28.4 White Non-Hispanic/non- Latino13AUG2020 C4591001 1018 10181148 31 Male 192.02 113.64 30.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1018 10181149 48 Female 167.64 75.55 26.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1018 10181150 37 Female 160.02 65.91 25.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1018 10181151 42 Female 158.5 69.55 27.6 White Hispanic/Latino 13AUG2020 C4591001 1018 10181152 42 Female 160.02 70.09 27.3 Asian Non-Hispanic/non- Latino13AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 45 FDA-CBER-2021-5683-0032415 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1018 10181154 40 Male 193.04 115.18 30.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1018 10181156 40 Female 157.48 61.36 24.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1018 10181157 36 Female 160.02 58.27 22.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1018 10181158 49 Male 177.8 71.82 22.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1018 10181159 53 Female 176.53 62.27 19.9 White Non-Hispanic/non- Latino14AUG2020 C4591001 1018 10181160 37 Male 185.42 93.5 27.1 White Non-Hispanic/non- Latino14AUG2020 C4591001 1018 10181162 39 Male 177.8 88.64 28 White Non-Hispanic/non- Latino14AUG2020 C4591001 1018 10181163 27 Female 155.7 56.45 23.2 White Non-Hispanic/non- Latino14AUG2020 C4591001 1018 10181167 35 Male 185.42 79.36 23 White Non-Hispanic/non- Latino14AUG2020 C4591001 1018 10181186 33 Female 165.1 76.09 27.9 White Non-Hispanic/non- Latino19AUG2020 C4591001 1019 10191002 31 Female 173.99 68.09 22.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1019 10191005 30 Male 180.34 83.45 25.6 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1019 10191006 48 Female 166.37 90.32 32.6 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1019 10191007 49 Female 166.37 65.86 23.7 White Non-Hispanic/non- Latino10AUG2020 C4591001 1019 10191015 46 Female 160.02 85.27 33.2 White Non-Hispanic/non- Latino11AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 46 FDA-CBER-2021-5683-0032416 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1019 10191018 35 Male 167.64 107.05 38 White Hispanic/Latino 12AUG2020 C4591001 1019 10191023 26 Male 180.34 97.95 30.1 Black or African American Non-Hispanic/non- Latino12AUG2020 C4591001 1019 10191027 46 Female 163.83 80.73 30 White Non-Hispanic/non- Latino13AUG2020 C4591001 1019 10191028 55 Male 170.82 77.55 26.5 White Non-Hispanic/non- Latino13AUG2020 C4591001 1019 10191032 24 Male 186.69 58.73 16.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1019 10191034 33 Male 161.29 53.5 20.5 White Non-Hispanic/non- Latino13AUG2020 C4591001 1019 10191036 40 Female 172.72 70.41 23.5 White Non-Hispanic/non- Latino13AUG2020 C4591001 1019 10191038 47 Female 157.48 80.82 32.5 White Hispanic/Latino 14AUG2020 C4591001 1019 10191041 21 Male 163.83 82.23 30.6 White Hispanic/Latino 14AUG2020 C4591001 1021 10211011 55 Male 188 134 37.9 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1021 10211012 50 Female 157 63.1 25.6 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1021 10211016 41 Male 180 84.7 26.1 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1021 10211032 51 Female 163 95.2 35.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1021 10211040 44 Male 179 82.5 25.7 White Non-Hispanic/non- Latino14AUG2020 C4591001 1022 10221004 48 Male 179.07 129.55 40.3 White Non-Hispanic/non- Latino14AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 47 FDA-CBER-2021-5683-0032417 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1024 10241001 46 Female 152.4 57.73 24.8 White Non-Hispanic/non- Latino12AUG2020 C4591001 1024 10241002 51 Female 162.56 85.45 32.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1024 10241004 31 Female 165.1 72.73 26.6 White Non-Hispanic/non- Latino12AUG2020 C4591001 1024 10241005 47 Female 160.02 61.36 23.9 White Non-Hispanic/non- Latino12AUG2020 C4591001 1024 10241006 49 Male 182.88 84.09 25.1 White Non-Hispanic/non- Latino12AUG2020 C4591001 1024 10241009 54 Male 180.34 79.55 24.4 White Non-Hispanic/non- Latino13AUG2020 C4591001 1024 10241011 51 Male 167.64 81.82 29 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1024 10241012 51 Male 187.96 100 28.2 White Non-Hispanic/non- Latino13AUG2020 C4591001 1024 10241014 43 Male 177.8 81.82 25.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1024 10241015 33 Female 167.64 55.45 19.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1024 10241016 54 Female 166.37 63.64 22.9 White Non-Hispanic/non- Latino13AUG2020 C4591001 1024 10241020 42 Female 167.64 90.91 32.3 White Non-Hispanic/non- Latino14AUG2020 C4591001 1024 10241021 54 Female 167.64 69.09 24.5 White Non-Hispanic/non- Latino14AUG2020 C4591001 1024 10241023 52 Female 154.94 77.27 32.1 White Non-Hispanic/non- Latino14AUG2020 C4591001 1027 10271005 51 Female 177.8 74.73 23.6 White Non-Hispanic/non- Latino13AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 48 FDA-CBER-2021-5683-0032418 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1027 10271012 39 Female 172.72 79.09 26.5 Black or African American Non-Hispanic/non- Latino14AUG2020 C4591001 1027 10271017 51 Male 177.8 76.09 24 White Non-Hispanic/non- Latino14AUG2020 C4591001 1027 10271019 53 Female 170.82 70.82 24.2 White Non-Hispanic/non- Latino14AUG2020 C4591001 1027 10271021 50 Male 175.26 83.36 27.1 White Non-Hispanic/non- Latino14AUG2020 C4591001 1028 10281001 38 Male 168.91 84.27 29.5 White Non-Hispanic/non- Latino13AUG2020 C4591001 1028 10281002 33 Male 178.05 77.09 24.3 White Non-Hispanic/non- Latino13AUG2020 C4591001 1028 10281003 41 Female 157.99 49.8 19.9 Asian Not reported 14AUG2020 C4591001 1042 10421013 43 Male 175.26 109 35.4 White Non-Hispanic/non- Latino31JUL2020 C4591001 1042 10421014 41 Female 167.64 93.18 33.1 White Non-Hispanic/non- Latino31JUL2020 C4591001 1042 10421017 38 Male 175.26 74.32 24.1 White Non-Hispanic/non- Latino31JUL2020 C4591001 1042 10421020 25 Male 171.45 97.27 33 White Non-Hispanic/non- Latino31JUL2020 C4591001 1042 10421021 53 Female 165.1 87.36 32 White Non-Hispanic/non- Latino03AUG2020 C4591001 1042 10421022 36 Male 185.42 75 21.8 White Non-Hispanic/non- Latino03AUG2020 C4591001 1042 10421024 43 Male 177.8 84.32 26.6 Black or African American Non-Hispanic/non- Latino03AUG2020 C4591001 1042 10421027 32 Female 162.56 83.82 31.6 White Non-Hispanic/non- Latino03AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 49 FDA-CBER-2021-5683-0032419 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1042 10421028 41 Male 182.88 118.18 35.3 White Non-Hispanic/non- Latino03AUG2020 C4591001 1042 10421029 44 Male 200.66 95.45 23.7 White Non-Hispanic/non- Latino03AUG2020 C4591001 1042 10421031 53 Female 162.56 80.45 30.4 Black or African American Non-Hispanic/non- Latino04AUG2020 C4591001 1042 10421034 38 Female 165.1 81.45 29.8 White Non-Hispanic/non- Latino04AUG2020 C4591001 1042 10421035 48 Female 165.1 75.91 27.8 White Non-Hispanic/non- Latino04AUG2020 C4591001 1042 10421039 38 Female 167.64 69.82 24.8 White Non-Hispanic/non- Latino04AUG2020 C4591001 1042 10421041 50 Female 157.48 58.64 23.6 White Non-Hispanic/non- Latino04AUG2020 C4591001 1042 10421043 52 Female 160.02 96.82 37.7 Black or African American Non-Hispanic/non- Latino05AUG2020 C4591001 1042 10421044 55 Male 182.88 97 28.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1042 10421045 51 Female 175.26 91.36 29.7 White Non-Hispanic/non- Latino05AUG2020 C4591001 1042 10421050 47 Female 152.4 51.82 22.3 Black or African American Non-Hispanic/non- Latino05AUG2020 C4591001 1042 10421051 27 Male 165.1 76.82 28.1 White Non-Hispanic/non- Latino06AUG2020 C4591001 1042 10421057 52 Female 172.72 117.36 39.3 White Hispanic/Latino 06AUG2020 C4591001 1042 10421059 26 Female 167.64 66.36 23.6 White Hispanic/Latino 07AUG2020 C4591001 1042 10421061 39 Male 170.18 66.45 22.9 White Non-Hispanic/non- Latino07AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 50 FDA-CBER-2021-5683-0032420 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1042 10421063 45 Male 182.88 105 31.3 White Non-Hispanic/non- Latino07AUG2020 C4591001 1042 10421065 43 Male 187.96 126.18 35.6 White Non-Hispanic/non- Latino07AUG2020 C4591001 1042 10421068 38 Male 177.8 146.91 46.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1042 10421069 39 Male 175.26 87.45 28.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1042 10421070 40 Male 172.72 86.45 28.9 White Non-Hispanic/non- Latino10AUG2020 C4591001 1042 10421071 30 Female 157.48 85.45 34.4 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1042 10421073 39 Male 180.34 84.09 25.8 White Non-Hispanic/non- Latino10AUG2020 C4591001 1042 10421076 54 Female 165.1 108 39.5 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1042 10421077 50 Male 187.96 71.36 20.2 White Non-Hispanic/non- Latino10AUG2020 C4591001 1042 10421079 34 Female 156.21 66.73 27.3 White Hispanic/Latino 10AUG2020 C4591001 1042 10421080 52 Female 162.56 57.82 21.8 White Non-Hispanic/non- Latino10AUG2020 C4591001 1042 10421081 52 Male 182.88 68.18 20.3 White Non-Hispanic/non- Latino11AUG2020 C4591001 1042 10421082 26 Male 185.42 84.45 24.5 White Non-Hispanic/non- Latino11AUG2020 C4591001 1042 10421083 36 Male 187.96 100 28.2 White Non-Hispanic/non- Latino11AUG2020 C4591001 1042 10421085 42 Female 167.64 81.82 29 White Non-Hispanic/non- Latino11AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 51 FDA-CBER-2021-5683-0032421 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1042 10421088 48 Female 160.02 72.82 28.4 White Non-Hispanic/non- Latino11AUG2020 C4591001 1042 10421092 37 Male 175.26 68.18 22.1 White Non-Hispanic/non- Latino11AUG2020 C4591001 1042 10421093 44 Male 187.96 123.36 34.8 American Indian or Alaska Native Non-Hispanic/non- Latino12AUG2020 C4591001 1042 10421095 48 Female 160.02 127.27 49.6 White Non-Hispanic/non- Latino12AUG2020 C4591001 1042 10421100 44 Female 170.18 65.91 22.7 White Non-Hispanic/non- Latino12AUG2020 C4591001 1042 10421103 37 Female 175.26 122.73 39.9 Native Hawaiian or other Pacific Islande r Non-Hispanic/non- Latino12AUG2020 C4591001 1042 10421105 40 Female 170.18 69.45 23.9 White Non-Hispanic/non- Latino14AUG2020 C4591001 1042 10421106 51 Male 171.45 124.27 42.2 White Hispanic/Latino 14AUG2020 C4591001 1042 10421108 50 Male 176.53 86.36 27.7 White Non-Hispanic/non- Latino14AUG2020 C4591001 1042 10421109 33 Male 172.72 90.91 30.4 Asian Non-Hispanic/non- Latino14AUG2020 C4591001 1044 10441001 37 Male 181.61 104.64 31.7 White Non-Hispanic/non- Latino14AUG2020 C4591001 1046 10461001 34 Female 175.26 68.18 22.1 White Non-Hispanic/non- Latino12AUG2020 C4591001 1046 10461002 52 Male 175.26 63.64 20.7 White Non-Hispanic/non- Latino12AUG2020 C4591001 1046 10461005 28 Male 175.26 70 22.7 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1046 10461006 55 Male 170.18 86.36 29.8 White Hispanic/Latino 13AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 52 FDA-CBER-2021-5683-0032422 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1046 10461010 48 Female 170.18 72.73 25.1 White Non-Hispanic/non- Latino13AUG2020 C4591001 1046 10461011 49 Male 175.26 63.64 20.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1046 10461014 32 Female 177.8 88.18 27.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1046 10461016 37 Female 167.64 70.45 25 White Non-Hispanic/non- Latino13AUG2020 C4591001 1046 10461018 49 Male 179.07 90.91 28.3 White Non-Hispanic/non- Latino14AUG2020 C4591001 1046 10461020 51 Male 167.64 79.55 28.2 White Non-Hispanic/non- Latino14AUG2020 C4591001 1046 10461023 43 Female 175.26 104.55 34 White Non-Hispanic/non- Latino14AUG2020 C4591001 1046 10461024 47 Male 187.96 99.09 28 White Non-Hispanic/non- Latino14AUG2020 C4591001 1046 10461026 47 Female 162.56 62.73 23.7 White Non-Hispanic/non- Latino14AUG2020 C4591001 1046 10461027 45 Female 160.02 81.82 31.9 White Non-Hispanic/non- Latino14AUG2020 C4591001 1046 10461028 41 Female 170.18 83.18 28.7 White Non-Hispanic/non- Latino14AUG2020 C4591001 1046 10461029 29 Female 160.02 68.18 26.6 White Hispanic/Latino 14AUG2020 C4591001 1046 10461030 38 Male 172.72 75 25.1 White Non-Hispanic/non- Latino14AUG2020 C4591001 1046 10461031 48 Female 170.18 69.55 24 White Non-Hispanic/non- Latino14AUG2020 C4591001 1046 10461039 31 Female 177.8 123.18 38.9 White Non-Hispanic/non- Latino15AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 53 FDA-CBER-2021-5683-0032423 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1048 10481001 49 Male 180.34 76.82 23.6 White Non-Hispanic/non- Latino07AUG2020 C4591001 1048 10481004 42 Male 179.07 119.55 37.2 American Indian or Alaska Native Non-Hispanic/non- Latino14AUG2020 C4591001 1055 10551001 55 Female 180.3 93.2 28.7 Black or African American Non-Hispanic/non- Latino06AUG2020 C4591001 1055 10551003 54 Female 157 73.9 30 White Non-Hispanic/non- Latino06AUG2020 C4591001 1055 10551007 26 Male 175.6 88.3 28.6 White Non-Hispanic/non- Latino07AUG2020 C4591001 1055 10551012 32 Female 156 59.6 24.5 White Non-Hispanic/non- Latino10AUG2020 C4591001 1055 10551013 35 Male 168 66.2 23.5 White Non-Hispanic/non- Latino10AUG2020 C4591001 1055 10551016 38 Female 177 68 21.7 White Non-Hispanic/non- Latino10AUG2020 C4591001 1055 10551020 53 Male 187 97.9 28 White Non-Hispanic/non- Latino11AUG2020 C4591001 1055 10551021 23 Female 167 59.2 21.2 White Non-Hispanic/non- Latino11AUG2020 C4591001 1055 10551022 49 Female 162.4 55.9 21.2 White Non-Hispanic/non- Latino11AUG2020 C4591001 1055 10551025 41 Female 161 58.3 22.5 White Non-Hispanic/non- Latino11AUG2020 C4591001 1055 10551026 47 Male 174 86.4 28.5 Asian Non-Hispanic/non- Latino11AUG2020 C4591001 1055 10551028 42 Female 146 40.1 18.8 Asian Non-Hispanic/non- Latino11AUG2020 C4591001 1055 10551029 54 Female 169.2 63.2 22.1 Multiracial Non-Hispanic/non- Latino12AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 54 FDA-CBER-2021-5683-0032424 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1055 10551032 54 Female 165.9 51.7 18.8 White Non-Hispanic/non- Latino12AUG2020 C4591001 1055 10551034 51 Female 174 62.7 20.7 White Non-Hispanic/non- Latino12AUG2020 C4591001 1055 10551037 40 Male 178.5 83.3 26.1 Native Hawaiian or other Pacific Islande r Non-Hispanic/non- Latino12AUG2020 C4591001 1055 10551040 38 Male 177 106.4 34 White Hispanic/Latino 13AUG2020 C4591001 1055 10551042 54 Male 183.5 79.9 23.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1055 10551043 39 Male 169.5 88.2 30.7 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1055 10551045 47 Male 171.5 75.5 25.7 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1055 10551046 41 Female 158 62.5 25 White Non-Hispanic/non- Latino13AUG2020 C4591001 1056 10561013 44 Female 154 63 26.6 White Hispanic/Latino 21AUG2020 C4591001 1057 10571001 32 Male 182.8 92.3 27.6 White Non-Hispanic/non- Latino12AUG2020 C4591001 1057 10571002 41 Male 187 85.4 24.4 White Non-Hispanic/non- Latino12AUG2020 C4591001 1057 10571005 51 Male 181.8 88.6 26.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1057 10571006 54 Female 165.2 94.5 34.6 White Non-Hispanic/non- Latino13AUG2020 C4591001 1057 10571007 50 Male 181.8 88.6 26.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1057 10571008 27 Male 193.1 93.5 25.1 White Non-Hispanic/non- Latino13AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 55 FDA-CBER-2021-5683-0032425 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1057 10571009 52 Male 165 65 23.9 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1057 10571012 48 Female 165.1 86.3 31.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1057 10571013 35 Male 188 94 26.6 White Non-Hispanic/non- Latino13AUG2020 C4591001 1057 10571014 22 Female 161.6 63.7 24.4 White Hispanic/Latino 13AUG2020 C4591001 1057 10571015 48 Male 176.5 82.5 26.5 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1057 10571016 49 Male 164.9 98 36 White Non-Hispanic/non- Latino14AUG2020 C4591001 1057 10571017 39 Female 166.7 70 25.2 White Non-Hispanic/non- Latino14AUG2020 C4591001 1057 10571018 28 Female 172.8 98.5 33 White Non-Hispanic/non- Latino14AUG2020 C4591001 1057 10571019 41 Female 172.2 82 27.7 White Non-Hispanic/non- Latino14AUG2020 C4591001 1057 10571024 53 Female 167 84.1 30.2 White Non-Hispanic/non- Latino14AUG2020 C4591001 1066 10661002 34 Male 179.07 93.82 29.2 Asian Non-Hispanic/non- Latino11AUG2020 C4591001 1066 10661015 51 Female 168.91 59 20.6 White Non-Hispanic/non- Latino12AUG2020 C4591001 1066 10661019 54 Male 173.99 114.18 37.6 White Hispanic/Latino 12AUG2020 C4591001 1066 10661020 52 Female 172.72 91.82 30.7 White Non-Hispanic/non- Latino12AUG2020 C4591001 1066 10661022 52 Female 165.1 71.36 26.1 White Non-Hispanic/non- Latino13AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 56 FDA-CBER-2021-5683-0032426 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1066 10661025 53 Female 165.1 84.27 30.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1066 10661026 35 Male 175.26 99.86 32.4 White Non-Hispanic/non- Latino13AUG2020 C4591001 1066 10661027 27 Female 162.56 76.09 28.7 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1066 10661028 37 Male 172.72 120.91 40.4 White Non-Hispanic/non- Latino13AUG2020 C4591001 1071 10711004 47 Female 163.8 100.7 37.5 White Hispanic/Latino 10AUG2020 C4591001 1071 10711005 55 Male 175.3 105.2 34.2 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1071 10711006 53 Female 163.8 95.7 35.7 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1071 10711008 55 Female 175.3 126.1 41 White Non-Hispanic/non- Latino10AUG2020 C4591001 1071 10711019 32 Female 160 49.9 19.5 White Non-Hispanic/non- Latino11AUG2020 C4591001 1071 10711020 53 Male 165.1 94.8 34.8 White Hispanic/Latino 12AUG2020 C4591001 1071 10711021 54 Male 172.7 59 19.8 Black or African American Non-Hispanic/non- Latino12AUG2020 C4591001 1071 10711022 47 Male 167.6 120.7 43 Multiracial Non-Hispanic/non- Latino12AUG2020 C4591001 1071 10711026 31 Female 175.3 153.3 49.9 Black or African American Non-Hispanic/non- Latino12AUG2020 C4591001 1071 10711027 49 Male 170.2 163.3 56.4 White Hispanic/Latino 12AUG2020 C4591001 1071 10711028 54 Female 177.8 105.7 33.4 Black or African American Non-Hispanic/non- Latino12AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 57 FDA-CBER-2021-5683-0032427 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1071 10711030 37 Male 190.5 103 28.4 White Non-Hispanic/non- Latino13AUG2020 C4591001 1071 10711034 49 Female 160 78.9 30.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1071 10711036 42 Female 167.6 117.9 42 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1071 10711037 49 Female 165.1 107.5 39.4 White Non-Hispanic/non- Latino14AUG2020 C4591001 1071 10711039 19 Female 167.6 127.9 45.5 White Hispanic/Latino 14AUG2020 C4591001 1071 10711040 52 Female 166.4 127.9 46.2 White Non-Hispanic/non- Latino14AUG2020 C4591001 1071 10711041 43 Female 177.8 173.3 54.8 Black or African American Non-Hispanic/non- Latino14AUG2020 C4591001 1071 10711042 47 Female 157.5 80.7 32.5 Asian Non-Hispanic/non- Latino14AUG2020 C4591001 1071 10711045 55 Male 179.1 105.2 32.8 White Non-Hispanic/non- Latino14AUG2020 C4591001 1071 10711047 50 Female 162.6 78.9 29.8 White Non-Hispanic/non- Latino14AUG2020 C4591001 1073 10731016 48 Male 167.3 63.5 22.7 White Non-Hispanic/non- Latino31JUL2020 C4591001 1073 10731020 51 Male 175.2 85.7 27.9 White Non-Hispanic/non- Latino31JUL2020 C4591001 1073 10731021 54 Female 172 108 36.5 White Non-Hispanic/non- Latino31JUL2020 C4591001 1073 10731022 38 Male 177 98.8 31.5 White Non-Hispanic/non- Latino03AUG2020 C4591001 1073 10731027 43 Male 167.1 104.3 37.4 White Non-Hispanic/non- Latino03AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 58 FDA-CBER-2021-5683-0032428 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1073 10731028 32 Female 164 94.6 35.2 White Non-Hispanic/non- Latino04AUG2020 C4591001 1073 10731029 43 Female 154 76 32 White Hispanic/Latino 04AUG2020 C4591001 1073 10731032 55 Female 168 71.5 25.3 White Non-Hispanic/non- Latino04AUG2020 C4591001 1073 10731034 51 Female 158.7 104.4 41.5 White Non-Hispanic/non- Latino04AUG2020 C4591001 1073 10731036 50 Female 161.4 59.3 22.8 White Non-Hispanic/non- Latino05AUG2020 C4591001 1073 10731038 22 Male 165 55.2 20.3 White Hispanic/Latino 05AUG2020 C4591001 1073 10731045 47 Female 171.2 98.2 33.5 White Non-Hispanic/non- Latino06AUG2020 C4591001 1073 10731048 24 Female 159.2 104.7 41.3 White Hispanic/Latino 06AUG2020 C4591001 1073 10731050 45 Female 157 77 31.2 White Non-Hispanic/non- Latino06AUG2020 C4591001 1073 10731056 51 Female 169.7 100.6 34.9 White Non-Hispanic/non- Latino10AUG2020 C4591001 1073 10731057 48 Female 159 73.3 29 White Non-Hispanic/non- Latino10AUG2020 C4591001 1073 10731059 53 Female 161.8 83.2 31.8 White Non-Hispanic/non- Latino10AUG2020 C4591001 1073 10731062 43 Male 169.2 144.6 50.5 White Hispanic/Latino 11AUG2020 C4591001 1073 10731063 52 Female 151.6 68.7 29.9 Asian Non-Hispanic/non- Latino11AUG2020 C4591001 1073 10731064 23 Female 162.3 61.9 23.5 White Non-Hispanic/non- Latino11AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 59 FDA-CBER-2021-5683-0032429 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1073 10731065 41 Female 170 75.3 26.1 White Non-Hispanic/non- Latino11AUG2020 C4591001 1073 10731067 24 Female 161.6 55.5 21.3 White Non-Hispanic/non- Latino11AUG2020 C4591001 1073 10731068 39 Male 170 71.8 24.8 White Non-Hispanic/non- Latino11AUG2020 C4591001 1073 10731077 55 Female 161.1 75.6 29.1 White Non-Hispanic/non- Latino12AUG2020 C4591001 1073 10731079 50 Female 162.6 77.1 29.2 White Hispanic/Latino 12AUG2020 C4591001 1073 10731081 50 Male 178 130.5 41.2 White Non-Hispanic/non- Latino12AUG2020 C4591001 1073 10731083 25 Male 173 85.4 28.5 White Non-Hispanic/non- Latino13AUG2020 C4591001 1073 10731084 43 Female 160 68.4 26.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1073 10731085 51 Female 162.5 107 40.5 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1077 10771001 51 Female 158.5 77.7 30.9 White Non-Hispanic/non- Latino10AUG2020 C4591001 1077 10771002 30 Female 172 66.8 22.6 White Non-Hispanic/non- Latino10AUG2020 C4591001 1077 10771003 43 Male 187.96 171.36 48.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1077 10771004 51 Female 160 88.5 34.6 White Non-Hispanic/non- Latino10AUG2020 C4591001 1077 10771007 32 Female 171.5 81.5 27.7 White Non-Hispanic/non- Latino10AUG2020 C4591001 1077 10771008 23 Female 162 60.2 22.9 White Non-Hispanic/non- Latino10AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 60 FDA-CBER-2021-5683-0032430 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1077 10771009 26 Male 163 60.7 22.8 Asian Non-Hispanic/non- Latino10AUG2020 C4591001 1077 10771010 20 Male 182.88 84.09 25.1 White Non-Hispanic/non- Latino10AUG2020 C4591001 1077 10771013 26 Female 152 120.3 52.1 White Non-Hispanic/non- Latino10AUG2020 C4591001 1077 10771014 31 Female 163 128.3 48.3 White Non-Hispanic/non- Latino10AUG2020 C4591001 1077 10771015 44 Male 173 86.5 28.9 White Non-Hispanic/non- Latino11AUG2020 C4591001 1077 10771018 42 Female 168 67.5 23.9 White Non-Hispanic/non- Latino11AUG2020 C4591001 1077 10771019 49 Female 166 61.7 22.4 White Non-Hispanic/non- Latino11AUG2020 C4591001 1077 10771020 26 Female 164 87.9 32.7 White Non-Hispanic/non- Latino11AUG2020 C4591001 1077 10771023 39 Female 171 91.6 31.3 White Non-Hispanic/non- Latino11AUG2020 C4591001 1077 10771027 43 Female 170 84 29.1 White Non-Hispanic/non- Latino11AUG2020 C4591001 1077 10771028 38 Male 179 91.7 28.6 White Non-Hispanic/non- Latino11AUG2020 C4591001 1077 10771029 55 Female 170.18 88.55 30.5 White Non-Hispanic/non- Latino11AUG2020 C4591001 1077 10771030 49 Male 181.5 75.4 22.9 White Non-Hispanic/non- Latino12AUG2020 C4591001 1077 10771031 34 Male 190 95.3 26.4 White Non-Hispanic/non- Latino12AUG2020 C4591001 1077 10771035 41 Male 174 86.3 28.5 White Non-Hispanic/non- Latino12AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 61 FDA-CBER-2021-5683-0032431 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1077 10771036 26 Female 154 52.6 22.2 White Non-Hispanic/non- Latino12AUG2020 C4591001 1077 10771037 54 Male 182 108 32.6 White Non-Hispanic/non- Latino12AUG2020 C4591001 1077 10771038 36 Male 177.8 79.77 25.2 White Non-Hispanic/non- Latino12AUG2020 C4591001 1079 10791017 32 Female 180.34 99 30.4 White Non-Hispanic/non- Latino31JUL2020 C4591001 1079 10791018 42 Male 181.5 111.7 33.9 White Non-Hispanic/non- Latino31JUL2020 C4591001 1079 10791021 53 Male 183 106.7 31.9 White Non-Hispanic/non- Latino31JUL2020 C4591001 1079 10791022 47 Female 171.5 160.5 54.6 White Non-Hispanic/non- Latino31JUL2020 C4591001 1079 10791037 41 Female 169.5 66.4 23.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1079 10791039 54 Female 160.5 68 26.4 Asian Non-Hispanic/non- Latino03AUG2020 C4591001 1079 10791040 40 Female 161.5 78.3 30 White Hispanic/Latino 03AUG2020 C4591001 1079 10791046 55 Female 166 98 35.6 White Non-Hispanic/non- Latino04AUG2020 C4591001 1079 10791047 41 Female 163 108.8 40.9 White Non-Hispanic/non- Latino04AUG2020 C4591001 1079 10791048 52 Female 161.5 57.6 22.1 White Non-Hispanic/non- Latino04AUG2020 C4591001 1079 10791050 46 Female 162 91.6 34.9 Black or African American Non-Hispanic/non- Latino04AUG2020 C4591001 1079 10791053 42 Male 185 156.6 45.8 White Non-Hispanic/non- Latino05AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 62 FDA-CBER-2021-5683-0032432 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1079 10791054 28 Female 157.48 83.18 33.5 White Non-Hispanic/non- Latino05AUG2020 C4591001 1079 10791058 47 Female 154.94 49.09 20.4 Asian Non-Hispanic/non- Latino05AUG2020 C4591001 1079 10791059 20 Female 148.59 50.73 22.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1079 10791060 47 Female 168 94.3 33.4 White Non-Hispanic/non- Latino05AUG2020 C4591001 1079 10791061 36 Male 181.61 133.82 40.5 White Non-Hispanic/non- Latino05AUG2020 C4591001 1079 10791062 46 Male 183.1 114.4 34.1 Black or African American Non-Hispanic/non- Latino05AUG2020 C4591001 1079 10791063 55 Male 177.8 106 33.5 White Non-Hispanic/non- Latino05AUG2020 C4591001 1079 10791072 29 Male 178 122.1 38.5 White Non-Hispanic/non- Latino06AUG2020 C4591001 1079 10791073 34 Female 167.64 95.45 33.9 White Non-Hispanic/non- Latino06AUG2020 C4591001 1079 10791075 41 Male 181.5 102.3 31.1 White Non-Hispanic/non- Latino07AUG2020 C4591001 1079 10791077 30 Male 187.96 95.45 27 White Non-Hispanic/non- Latino07AUG2020 C4591001 1079 10791079 48 Female 182.88 70.45 21 White Non-Hispanic/non- Latino07AUG2020 C4591001 1079 10791082 55 Female 170.18 74.55 25.7 White Non-Hispanic/non- Latino07AUG2020 C4591001 1079 10791086 47 Male 175.5 66.5 21.6 White Non-Hispanic/non- Latino10AUG2020 C4591001 1079 10791087 52 Male 180.34 86.82 26.6 White Non-Hispanic/non- Latino10AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 63 FDA-CBER-2021-5683-0032433 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1079 10791089 52 Female 168.91 69 24.1 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1079 10791090 53 Male 193.04 93.2 25 White Non-Hispanic/non- Latino10AUG2020 C4591001 1079 10791091 30 Male 189 104.5 29.3 White Non-Hispanic/non- Latino10AUG2020 C4591001 1079 10791096 32 Male 155.45 120.27 49.7 White Non-Hispanic/non- Latino11AUG2020 C4591001 1079 10791097 36 Female 176 72.9 23.5 White Non-Hispanic/non- Latino11AUG2020 C4591001 1079 10791098 53 Male 181 192.6 58.8 White Non-Hispanic/non- Latino11AUG2020 C4591001 1079 10791099 45 Male 175.26 92.09 29.9 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1079 10791102 37 Male 189.5 79.47 22.1 White Non-Hispanic/non- Latino12AUG2020 C4591001 1079 10791106 48 Male 170.18 52.64 18.1 Black or African American Non-Hispanic/non- Latino12AUG2020 C4591001 1079 10791107 48 Male 182 111.76 33.7 White Non-Hispanic/non- Latino12AUG2020 C4591001 1079 10791109 34 Female 165.1 64.09 23.5 White Non-Hispanic/non- Latino12AUG2020 C4591001 1079 10791110 32 Female 157.48 68.45 27.5 White Non-Hispanic/non- Latino12AUG2020 C4591001 1079 10791112 47 Male 192 97.3 26.4 White Non-Hispanic/non- Latino12AUG2020 C4591001 1079 10791113 22 Male 167 71.4 25.6 White Non-Hispanic/non- Latino12AUG2020 C4591001 1079 10791114 55 Male 180.34 90 27.6 White Non-Hispanic/non- Latino12AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 64 FDA-CBER-2021-5683-0032434 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1079 10791115 50 Female 152.5 59.5 25.6 Asian Non-Hispanic/non- Latino12AUG2020 C4591001 1079 10791116 50 Male 179 97.5 30.4 White Non-Hispanic/non- Latino12AUG2020 C4591001 1079 10791117 38 Male 169 139.7 48.9 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1079 10791118 45 Female 161.29 77.77 29.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1079 10791120 39 Male 179.07 106.73 33.2 White Non-Hispanic/non- Latino13AUG2020 C4591001 1079 10791124 54 Male 182.5 101.5 30.5 White Hispanic/Latino 13AUG2020 C4591001 1079 10791125 48 Female 161.5 82.7 31.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1079 10791126 35 Male 177.8 94.09 29.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1079 10791127 51 Female 170.18 76.82 26.5 White Non-Hispanic/non- Latino13AUG2020 C4591001 1079 10791162 20 Male 189 78.3 21.9 White Non-Hispanic/non- Latino20AUG2020 C4591001 1080 10801001 52 Male 191.8 96.9 26.3 White Non-Hispanic/non- Latino10AUG2020 C4591001 1080 10801002 49 Female 162 66.9 25.5 White Non-Hispanic/non- Latino10AUG2020 C4591001 1080 10801003 43 Female 175.3 81.6 26.6 White Non-Hispanic/non- Latino10AUG2020 C4591001 1080 10801004 27 Female 165.1 160.1 58.7 White Non-Hispanic/non- Latino10AUG2020 C4591001 1080 10801009 20 Female 177.8 62.4 19.7 White Non-Hispanic/non- Latino11AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 65 FDA-CBER-2021-5683-0032435 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1080 10801010 37 Female 157 53.8 21.8 White Non-Hispanic/non- Latino11AUG2020 C4591001 1080 10801017 45 Female 166 61.3 22.2 White Non-Hispanic/non- Latino12AUG2020 C4591001 1080 10801018 52 Female 159.4 66.8 26.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1080 10801019 25 Female 166.1 114.4 41.5 White Non-Hispanic/non- Latino12AUG2020 C4591001 1080 10801022 24 Male 182.9 77.2 23.1 White Non-Hispanic/non- Latino12AUG2020 C4591001 1080 10801023 32 Female 175.2 66.5 21.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1080 10801026 29 Male 182.8 124.6 37.3 White Non-Hispanic/non- Latino13AUG2020 C4591001 1080 10801027 53 Female 158.7 90.5 35.9 White Non-Hispanic/non- Latino13AUG2020 C4591001 1080 10801032 52 Male 180.5 100.5 30.8 White Non-Hispanic/non- Latino14AUG2020 C4591001 1080 10801033 44 Female 158.5 58.3 23.2 White Non-Hispanic/non- Latino14AUG2020 C4591001 1081 10811001 52 Male 170.18 109.36 37.7 White Non-Hispanic/non- Latino10AUG2020 C4591001 1081 10811003 35 Female 165.1 113.91 41.7 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1081 10811006 27 Female 162.56 78.45 29.6 White Non-Hispanic/non- Latino10AUG2020 C4591001 1081 10811008 50 Male 180.34 113.64 34.9 White Non-Hispanic/non- Latino10AUG2020 C4591001 1081 10811009 48 Male 187.96 85.45 24.1 White Hispanic/Latino 10AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 66 FDA-CBER-2021-5683-0032436 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1081 10811010 55 Male 177.8 93.09 29.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1081 10811012 25 Male 180.34 101.09 31 White Non-Hispanic/non- Latino10AUG2020 C4591001 1081 10811013 21 Male 170.18 63.64 21.9 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1081 10811018 51 Female 167.64 76.91 27.3 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1081 10811020 34 Female 165.1 94.45 34.6 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1081 10811023 27 Male 184.15 112.18 33 White Non-Hispanic/non- Latino12AUG2020 C4591001 1081 10811025 36 Male 187.96 127.36 36 White Non-Hispanic/non- Latino12AUG2020 C4591001 1081 10811032 30 Female 167.64 85.91 30.5 Black or African American Non-Hispanic/non- Latino12AUG2020 C4591001 1081 10811033 30 Male 187.96 150 42.4 White Non-Hispanic/non- Latino12AUG2020 C4591001 1081 10811036 51 Female 158.75 72.82 28.8 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1081 10811038 32 Male 173.23 88.09 29.3 White Non-Hispanic/non- Latino13AUG2020 C4591001 1082 10821006 45 Female 163.2 92.2 34.6 White Non-Hispanic/non- Latino31JUL2020 C4591001 1082 10821008 47 Female 163.9 89.3 33.2 White Non-Hispanic/non- Latino31JUL2020 C4591001 1082 10821009 31 Male 169 84.6 29.6 White Non-Hispanic/non- Latino03AUG2020 C4591001 1082 10821011 37 Female 157 77.6 31.5 White Non-Hispanic/non- Latino03AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 67 FDA-CBER-2021-5683-0032437 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1082 10821014 25 Male 174 71.9 23.7 White Non-Hispanic/non- Latino03AUG2020 C4591001 1082 10821015 43 Female 158 67.2 26.9 White Non-Hispanic/non- Latino03AUG2020 C4591001 1082 10821016 46 Female 156 71 29.2 White Non-Hispanic/non- Latino03AUG2020 C4591001 1082 10821018 40 Female 171.5 85.2 29 White Non-Hispanic/non- Latino03AUG2020 C4591001 1082 10821019 40 Female 173.6 90.1 29.9 White Non-Hispanic/non- Latino03AUG2020 C4591001 1082 10821020 46 Female 158.3 92.7 37 White Non-Hispanic/non- Latino03AUG2020 C4591001 1082 10821021 52 Male 176 125.3 40.5 White Non-Hispanic/non- Latino04AUG2020 C4591001 1082 10821022 53 Male 168 89.1 31.6 White Non-Hispanic/non- Latino04AUG2020 C4591001 1082 10821023 53 Male 179.2 82.4 25.7 White Non-Hispanic/non- Latino04AUG2020 C4591001 1082 10821024 20 Male 170.6 79.7 27.4 White Hispanic/Latino 04AUG2020 C4591001 1082 10821025 25 Female 164.8 68 25 White Non-Hispanic/non- Latino04AUG2020 C4591001 1082 10821026 48 Male 184 158.9 46.9 White Non-Hispanic/non- Latino04AUG2020 C4591001 1082 10821027 55 Male 181 125.6 38.3 White Non-Hispanic/non- Latino04AUG2020 C4591001 1082 10821028 39 Female 162 104.4 39.8 White Non-Hispanic/non- Latino04AUG2020 C4591001 1082 10821031 53 Male 185 100.9 29.5 White Non-Hispanic/non- Latino04AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 68 FDA-CBER-2021-5683-0032438 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1082 10821034 42 Male 183 89.3 26.7 White Non-Hispanic/non- Latino04AUG2020 C4591001 1082 10821035 52 Female 165 78.3 28.8 White Non-Hispanic/non- Latino04AUG2020 C4591001 1082 10821036 24 Female 172 80.2 27.1 White Non-Hispanic/non- Latino04AUG2020 C4591001 1082 10821037 27 Male 182.3 81.8 24.6 White Non-Hispanic/non- Latino04AUG2020 C4591001 1082 10821038 42 Female 173.4 111.8 37.2 White Non-Hispanic/non- Latino05AUG2020 C4591001 1082 10821039 49 Female 169 96.6 33.8 White Non-Hispanic/non- Latino05AUG2020 C4591001 1082 10821041 52 Female 165.5 81.8 29.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1082 10821043 37 Female 168.3 88.5 31.2 White Non-Hispanic/non- Latino05AUG2020 C4591001 1082 10821044 21 Male 172.5 98.1 33 White Non-Hispanic/non- Latino05AUG2020 C4591001 1082 10821045 37 Female 160 54 21.1 White Non-Hispanic/non- Latino05AUG2020 C4591001 1082 10821047 38 Male 183.1 137.1 40.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1082 10821049 52 Female 155 55.2 23 White Non-Hispanic/non- Latino05AUG2020 C4591001 1082 10821050 49 Female 156.5 66.9 27.3 White Non-Hispanic/non- Latino05AUG2020 C4591001 1082 10821053 53 Female 168.1 59.4 21 Black or African American Non-Hispanic/non- Latino05AUG2020 C4591001 1082 10821054 21 Female 158.5 105.9 42.2 Native Hawaiian or other Pacific Islande r Hispanic/Latino 05AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 69 FDA-CBER-2021-5683-0032439 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1082 10821056 52 Male 174 113.4 37.5 White Non-Hispanic/non- Latino06AUG2020 C4591001 1082 10821060 36 Female 167.5 93.6 33.4 White Non-Hispanic/non- Latino06AUG2020 C4591001 1082 10821064 34 Male 184.4 132.8 39.1 White Non-Hispanic/non- Latino06AUG2020 C4591001 1082 10821065 51 Male 198 129.1 32.9 White Non-Hispanic/non- Latino06AUG2020 C4591001 1082 10821066 40 Female 177.1 80 25.5 White Non-Hispanic/non- Latino06AUG2020 C4591001 1082 10821067 29 Male 185.9 152.1 44 White Non-Hispanic/non- Latino06AUG2020 C4591001 1082 10821069 47 Female 165 80.6 29.6 White Non-Hispanic/non- Latino06AUG2020 C4591001 1082 10821070 32 Male 180 98.9 30.5 White Non-Hispanic/non- Latino06AUG2020 C4591001 1082 10821071 52 Female 161.9 99.3 37.9 White Non-Hispanic/non- Latino07AUG2020 C4591001 1082 10821072 53 Female 171 105.4 36 White Non-Hispanic/non- Latino07AUG2020 C4591001 1082 10821073 51 Male 177 88.5 28.2 White Non-Hispanic/non- Latino07AUG2020 C4591001 1082 10821077 39 Female 156 65.6 27 White Non-Hispanic/non- Latino07AUG2020 C4591001 1082 10821078 35 Male 184 137.1 40.5 White Non-Hispanic/non- Latino07AUG2020 C4591001 1082 10821080 42 Female 165.7 86.9 31.7 White Non-Hispanic/non- Latino07AUG2020 C4591001 1082 10821081 52 Male 187.1 110.6 31.6 White Non-Hispanic/non- Latino07AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 70 FDA-CBER-2021-5683-0032440 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1082 10821082 44 Male 166 98.4 35.7 White Non-Hispanic/non- Latino07AUG2020 C4591001 1082 10821083 36 Male 177.2 108.4 34.5 White Non-Hispanic/non- Latino07AUG2020 C4591001 1082 10821084 43 Male 178 84.6 26.7 White Non-Hispanic/non- Latino07AUG2020 C4591001 1082 10821085 26 Male 189 157.4 44.1 White Non-Hispanic/non- Latino07AUG2020 C4591001 1082 10821088 49 Male 171 91.4 31.3 White Non-Hispanic/non- Latino10AUG2020 C4591001 1082 10821089 40 Female 165.7 77 28 White Non-Hispanic/non- Latino10AUG2020 C4591001 1082 10821090 37 Male 173 76.5 25.6 White Non-Hispanic/non- Latino10AUG2020 C4591001 1082 10821095 53 Female 148.5 75.8 34.4 White Non-Hispanic/non- Latino11AUG2020 C4591001 1082 10821100 43 Male 186.4 82.1 23.6 White Non-Hispanic/non- Latino12AUG2020 C4591001 1082 10821102 47 Male 172 83 28.1 White Non-Hispanic/non- Latino13AUG2020 C4591001 1082 10821104 54 Male 175.6 92 29.8 White Non-Hispanic/non- Latino14AUG2020 C4591001 1082 10821105 51 Female 151.5 56.5 24.6 White Non-Hispanic/non- Latino14AUG2020 C4591001 1082 10821106 27 Female 163 74.5 28 White Non-Hispanic/non- Latino14AUG2020 C4591001 1082 10821107 30 Female 165.7 61.6 22.4 White Non-Hispanic/non- Latino14AUG2020 C4591001 1082 10821109 44 Male 176.8 79.1 25.3 White Non-Hispanic/non- Latino14AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 71 FDA-CBER-2021-5683-0032441 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1083 10831007 50 Male 175.26 72.27 23.5 White Non-Hispanic/non- Latino30JUL2020 C4591001 1083 10831009 49 Female 157.48 103.23 41.5 Black or African American Non-Hispanic/non- Latino30JUL2020 C4591001 1083 10831011 52 Female 164.47 76.45 28.2 White Non-Hispanic/non- Latino30JUL2020 C4591001 1083 10831013 30 Male 177.8 105.82 33.4 White Non-Hispanic/non- Latino30JUL2020 C4591001 1083 10831015 30 Female 162.56 102 38.5 Black or African American Non-Hispanic/non- Latino31JUL2020 C4591001 1083 10831017 40 Male 165.1 61.36 22.5 White Non-Hispanic/non- Latino31JUL2020 C4591001 1083 10831018 52 Female 170.18 101.82 35.1 Black or African American Non-Hispanic/non- Latino31JUL2020 C4591001 1083 10831020 39 Male 172.72 86.82 29 White Non-Hispanic/non- Latino03AUG2020 C4591001 1083 10831025 42 Male 182.88 117.55 35.1 White Non-Hispanic/non- Latino04AUG2020 C4591001 1083 10831026 41 Female 172.72 93.64 31.3 White Hispanic/Latino 04AUG2020 C4591001 1083 10831029 50 Male 180.34 132.18 40.6 White Non-Hispanic/non- Latino04AUG2020 C4591001 1083 10831032 41 Female 163.83 132 49.1 Black or African American Non-Hispanic/non- Latino04AUG2020 C4591001 1083 10831033 26 Male 166.37 76 27.4 White Non-Hispanic/non- Latino04AUG2020 C4591001 1083 10831034 35 Male 180.34 103.82 31.9 White Hispanic/Latino 04AUG2020 C4591001 1083 10831040 55 Female 165.1 109.55 40.1 White Non-Hispanic/non- Latino04AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 72 FDA-CBER-2021-5683-0032442 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1083 10831043 45 Female 165.1 99.64 36.5 White Non-Hispanic/non- Latino04AUG2020 C4591001 1083 10831044 42 Male 180.34 69.8 21.5 White Non-Hispanic/non- Latino05AUG2020 C4591001 1083 10831045 51 Male 177.8 132.68 41.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1083 10831046 45 Female 152.4 57.91 24.9 White Hispanic/Latino 05AUG2020 C4591001 1083 10831047 30 Male 175.26 74.36 24.2 White Non-Hispanic/non- Latino05AUG2020 C4591001 1083 10831052 55 Male 170.18 122.64 42.3 White Non-Hispanic/non- Latino05AUG2020 C4591001 1083 10831054 51 Female 170.18 114.95 39.6 White Hispanic/Latino 05AUG2020 C4591001 1083 10831055 51 Male 175.26 71.91 23.4 Black or African American Non-Hispanic/non- Latino05AUG2020 C4591001 1083 10831057 55 Female 154.94 105.68 43.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1083 10831060 45 Male 172.72 81.91 27.4 White Hispanic/Latino 06AUG2020 C4591001 1083 10831061 39 Female 151.13 64.27 28.1 White Non-Hispanic/non- Latino07AUG2020 C4591001 1083 10831062 19 Female 175.26 60.23 19.6 White Non-Hispanic/non- Latino07AUG2020 C4591001 1083 10831065 30 Male 182.88 82.18 24.5 White Hispanic/Latino 07AUG2020 C4591001 1083 10831067 26 Male 179.07 67.55 21 White Hispanic/Latino 07AUG2020 C4591001 1083 10831068 42 Female 166.37 74.32 26.8 White Hispanic/Latino 10AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 73 FDA-CBER-2021-5683-0032443 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1083 10831069 34 Female 166.37 106.73 38.5 White Non-Hispanic/non- Latino10AUG2020 C4591001 1083 10831070 42 Female 151.13 62.41 27.3 Asian Non-Hispanic/non- Latino10AUG2020 C4591001 1083 10831074 54 Female 165.1 61.91 22.7 Asian Non-Hispanic/non- Latino10AUG2020 C4591001 1083 10831078 40 Male 190.5 89.45 24.6 White Non-Hispanic/non- Latino10AUG2020 C4591001 1083 10831081 52 Female 159.39 88.73 34.9 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1083 10831082 21 Female 170.18 99 34.1 White Hispanic/Latino 11AUG2020 C4591001 1083 10831083 43 Female 166.37 65.59 23.6 White Hispanic/Latino 11AUG2020 C4591001 1083 10831084 20 Male 185.42 79.27 23 White Non-Hispanic/non- Latino11AUG2020 C4591001 1083 10831086 55 Male 170.43 89.68 30.8 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1083 10831090 32 Male 162.56 78.55 29.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1083 10831091 51 Female 162.56 56.45 21.3 White Non-Hispanic/non- Latino13AUG2020 C4591001 1083 10831093 30 Male 177.8 98.95 31.2 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1083 10831094 23 Female 157.99 51.95 20.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1083 10831098 38 Female 157.48 70.14 28.2 White Non-Hispanic/non- Latino13AUG2020 C4591001 1083 10831099 26 Male 182.88 85.91 25.6 White Non-Hispanic/non- Latino13AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 74 FDA-CBER-2021-5683-0032444 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1083 10831101 32 Male 186.69 65.14 18.6 Multiracial Hispanic/Latino 13AUG2020 C4591001 1083 10831102 47 Female 156.21 46.32 18.9 Multiracial Non-Hispanic/non- Latino13AUG2020 C4591001 1084 10841004 36 Male 175.4 115.9 37.7 White Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841008 39 Male 176.5 89.2 28.6 White Non-Hispanic/non- Latino30JUL2020 C4591001 1084 10841009 27 Male 179.9 87.5 27 Multiracial Non-Hispanic/non- Latino30JUL2020 C4591001 1084 10841012 26 Male 177.5 150 47.6 White Hispanic/Latino 03AUG2020 C4591001 1084 10841013 27 Male 170 85.4 29.6 Native Hawaiian or other Pacific Islande r Hispanic/Latino 03AUG2020 C4591001 1084 10841014 26 Male 177.1 157.9 50.3 White Non-Hispanic/non- Latino03AUG2020 C4591001 1084 10841015 32 Male 181.7 104.4 31.6 White Hispanic/Latino 03AUG2020 C4591001 1084 10841016 43 Male 166 70.9 25.7 White Hispanic/Latino 03AUG2020 C4591001 1084 10841017 41 Male 175.8 98.4 31.8 White Hispanic/Latino 03AUG2020 C4591001 1084 10841018 40 Male 178 77.1 24.3 White Non-Hispanic/non- Latino03AUG2020 C4591001 1084 10841023 43 Female 169.1 95.8 33.5 White Non-Hispanic/non- Latino03AUG2020 C4591001 1084 10841029 20 Female 163 54.3 20.4 White Non-Hispanic/non- Latino03AUG2020 C4591001 1084 10841031 22 Female 164.2 58 21.5 White Non-Hispanic/non- Latino03AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 75 FDA-CBER-2021-5683-0032445 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1084 10841033 34 Female 155.4 79.3 32.8 White Non-Hispanic/non- Latino03AUG2020 C4591001 1084 10841035 28 Female 159.5 69.05 27.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1084 10841036 45 Female 164.5 174.6 64.5 Black or African American Non-Hispanic/non- Latino05AUG2020 C4591001 1084 10841038 43 Female 165.1 57.65 21.1 White Non-Hispanic/non- Latino05AUG2020 C4591001 1084 10841041 43 Female 166 79.6 28.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1084 10841042 30 Female 154.5 45.4 19 White Non-Hispanic/non- Latino05AUG2020 C4591001 1084 10841044 34 Female 160.1 74.7 29.1 White Hispanic/Latino 05AUG2020 C4591001 1084 10841047 40 Female 159.5 98.6 38.8 White Hispanic/Latino 05AUG2020 C4591001 1084 10841054 47 Female 164.8 69.2 25.5 White Non-Hispanic/non- Latino05AUG2020 C4591001 1084 10841055 28 Female 159 69.8 27.6 Asian Non-Hispanic/non- Latino05AUG2020 C4591001 1084 10841056 33 Male 173.6 63.1 20.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1084 10841057 47 Female 150.2 66.4 29.4 White Hispanic/Latino 05AUG2020 C4591001 1084 10841058 28 Male 191.1 84.7 23.2 White Non-Hispanic/non- Latino05AUG2020 C4591001 1084 10841059 26 Female 171 58.2 19.9 White Hispanic/Latino 05AUG2020 C4591001 1084 10841060 37 Male 188 91 25.7 White Non-Hispanic/non- Latino07AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 76 FDA-CBER-2021-5683-0032446 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1084 10841061 52 Female 160.3 56 21.8 White Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841062 28 Female 163.5 91.2 34.1 White Hispanic/Latino 07AUG2020 C4591001 1084 10841064 40 Female 160.6 58.9 22.8 White Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841066 33 Female 177.6 104.3 33.1 White Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841068 32 Male 178.1 74.2 23.4 White Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841069 25 Female 155.9 59.2 24.4 White Hispanic/Latino 07AUG2020 C4591001 1084 10841071 29 Male 180.2 76 23.4 White Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841072 25 Male 176.5 71 22.8 White Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841073 36 Female 167 85.6 30.7 White Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841076 50 Female 164 95.1 35.4 Black or African American Hispanic/Latino 07AUG2020 C4591001 1084 10841079 43 Male 172.2 101.6 34.3 White Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841081 33 Male 179.5 79.3 24.6 White Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841082 51 Male 177.5 115 36.5 White Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841083 50 Male 181.8 74.3 22.5 White Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841084 42 Female 165.6 62.8 22.9 White Non-Hispanic/non- Latino07AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 77 FDA-CBER-2021-5683-0032447 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1084 10841085 34 Male 169 75.7 26.5 White Hispanic/Latino 07AUG2020 C4591001 1084 10841087 35 Female 160 88.8 34.7 White Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841089 28 Male 172.5 66.6 22.4 Asian Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841090 30 Male 181.5 96.1 29.2 White Hispanic/Latino 07AUG2020 C4591001 1084 10841091 49 Male 171.4 94.9 32.3 White Hispanic/Latino 07AUG2020 C4591001 1084 10841092 52 Female 169.1 65.6 22.9 White Non-Hispanic/non- Latino07AUG2020 C4591001 1084 10841095 51 Female 167 59.2 21.2 White Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841097 35 Male 186.9 97.7 28 White Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841098 54 Female 159.5 108 42.5 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841099 35 Female 169.8 61.3 21.3 White Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841100 41 Male 175.6 97.1 31.5 White Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841101 23 Male 172.5 65.1 21.9 White Hispanic/Latino 10AUG2020 C4591001 1084 10841102 51 Male 175.5 90.4 29.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841104 53 Female 162.1 89.3 34 White Hispanic/Latino 10AUG2020 C4591001 1084 10841107 54 Male 176.6 97.7 31.3 White Hispanic/Latino 10AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 78 FDA-CBER-2021-5683-0032448 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1084 10841111 55 Male 173 97.1 32.4 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841113 51 Female 163.8 54.5 20.3 Asian Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841114 54 Female 163.2 66.2 24.9 White Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841115 50 Female 161.2 53.1 20.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841117 30 Male 175 93.5 30.5 White Hispanic/Latino 10AUG2020 C4591001 1084 10841118 50 Male 184.6 91.5 26.9 White Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841119 36 Male 168.9 92.2 32.3 White Hispanic/Latino 10AUG2020 C4591001 1084 10841120 51 Male 170 86.4 29.9 White Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841121 47 Male 168 84.8 30 White Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841122 49 Female 164.4 82.6 30.6 White Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841123 51 Female 163.7 105.4 39.3 White Non-Hispanic/non- Latino10AUG2020 C4591001 1084 10841126 31 Male 187.5 109.9 31.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1084 10841129 55 Female 162 58.85 22.4 White Hispanic/Latino 12AUG2020 C4591001 1084 10841136 38 Female 157.2 108.2 43.8 White Hispanic/Latino 12AUG2020 C4591001 1084 10841137 41 Female 153.4 57 24.2 Asian Non-Hispanic/non- Latino12AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 79 FDA-CBER-2021-5683-0032449 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1084 10841138 38 Female 165.7 58.9 21.5 White Non-Hispanic/non- Latino12AUG2020 C4591001 1084 10841141 52 Male 185.4 87.1 25.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1084 10841146 40 Male 182.88 92.95 27.8 White Non-Hispanic/non- Latino12AUG2020 C4591001 1084 10841148 42 Male 180.4 98.4 30.2 White Hispanic/Latino 12AUG2020 C4591001 1084 10841153 32 Female 162 76.8 29.3 White Hispanic/Latino 12AUG2020 C4591001 1084 10841154 53 Female 146 55.95 26.2 White Hispanic/Latino 12AUG2020 C4591001 1084 10841155 45 Male 172.2 80.2 27 White Hispanic/Latino 14AUG2020 C4591001 1084 10841156 51 Female 154.7 74.8 31.3 Asian Non-Hispanic/non- Latino14AUG2020 C4591001 1084 10841159 51 Female 155 61.1 25.4 White Hispanic/Latino 14AUG2020 C4591001 1084 10841163 53 Male 191.2 116.25 31.8 White Non-Hispanic/non- Latino14AUG2020 C4591001 1084 10841164 38 Male 174.8 65.4 21.4 White Non-Hispanic/non- Latino14AUG2020 C4591001 1084 10841181 54 Male 171.7 82.1 27.8 White Non-Hispanic/non- Latino14AUG2020 C4591001 1084 10841182 50 Female 147.9 62.9 28.8 Black or African American Non-Hispanic/non- Latino14AUG2020 C4591001 1084 10841186 39 Female 179.8 88.2 27.3 White Non-Hispanic/non- Latino14AUG2020 C4591001 1085 10851013 55 Female 162.56 134.27 50.7 White Non-Hispanic/non- Latino30JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 80 FDA-CBER-2021-5683-0032450 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1085 10851014 49 Male 190.5 111.36 30.6 White Non-Hispanic/non- Latino30JUL2020 C4591001 1085 10851015 35 Male 162.31 57.36 21.7 Asian Non-Hispanic/non- Latino30JUL2020 C4591001 1085 10851016 53 Male 165.1 109.91 40.2 White Non-Hispanic/non- Latino01AUG2020 C4591001 1085 10851018 40 Female 170.18 104.55 36 White Non-Hispanic/non- Latino01AUG2020 C4591001 1085 10851019 19 Male 182.88 127.27 38 White Non-Hispanic/non- Latino01AUG2020 C4591001 1085 10851022 50 Female 170.18 59.45 20.5 White Non-Hispanic/non- Latino01AUG2020 C4591001 1085 10851023 45 Male 182.88 104.73 31.2 White Non-Hispanic/non- Latino01AUG2020 C4591001 1085 10851026 38 Male 182.88 113.21 33.8 White Non-Hispanic/non- Latino04AUG2020 C4591001 1085 10851027 50 Female 152.4 52.73 22.7 White Non-Hispanic/non- Latino04AUG2020 C4591001 1085 10851029 42 Male 187.96 159.14 44.9 White Non-Hispanic/non- Latino04AUG2020 C4591001 1085 10851032 51 Female 160.02 80.01 31.2 White Non-Hispanic/non- Latino05AUG2020 C4591001 1085 10851033 52 Female 165.1 71.45 26.2 White Non-Hispanic/non- Latino05AUG2020 C4591001 1085 10851034 51 Male 177.8 125.27 39.5 White Non-Hispanic/non- Latino05AUG2020 C4591001 1085 10851035 25 Male 190.5 97.73 26.9 White Not reported 05AUG2020 C4591001 1085 10851039 30 Female 167.64 58.18 20.7 White Non-Hispanic/non- Latino05AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 81 FDA-CBER-2021-5683-0032451 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1085 10851041 21 Male 175.26 78.18 25.4 White Non-Hispanic/non- Latino06AUG2020 C4591001 1085 10851047 50 Female 157.48 78.36 31.5 White Hispanic/Latino 06AUG2020 C4591001 1085 10851048 27 Female 163.83 96.45 35.9 White Hispanic/Latino 06AUG2020 C4591001 1085 10851049 22 Female 157.48 72.73 29.3 White Hispanic/Latino 06AUG2020 C4591001 1085 10851050 23 Male 177.8 86.36 27.3 White Hispanic/Latino 06AUG2020 C4591001 1085 10851051 44 Male 174.24 68.41 22.5 White Non-Hispanic/non- Latino07AUG2020 C4591001 1085 10851058 41 Female 160.02 59.09 23 White Hispanic/Latino 07AUG2020 C4591001 1085 10851062 32 Male 175.26 118.18 38.4 White Hispanic/Latino 07AUG2020 C4591001 1085 10851063 30 Female 154.94 195.45 81.2 White Hispanic/Latino 07AUG2020 C4591001 1085 10851064 26 Male 198.12 110.45 28.1 White Non-Hispanic/non- Latino08AUG2020 C4591001 1085 10851067 41 Female 177.8 109.09 34.4 White Non-Hispanic/non- Latino08AUG2020 C4591001 1085 10851068 43 Female 172.72 142.73 47.7 White Non-Hispanic/non- Latino08AUG2020 C4591001 1085 10851069 46 Male 157.48 54.64 22 Asian Non-Hispanic/non- Latino08AUG2020 C4591001 1085 10851070 27 Male 187.96 100.23 28.3 White Non-Hispanic/non- Latino08AUG2020 C4591001 1085 10851075 40 Female 162.56 90.91 34.3 White Non-Hispanic/non- Latino08AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 82 FDA-CBER-2021-5683-0032452 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1085 10851079 24 Female 166.37 62.27 22.4 American Indian or Alaska Native Non-Hispanic/non- Latino10AUG2020 C4591001 1085 10851081 22 Female 157.48 52.27 21 Asian Non-Hispanic/non- Latino10AUG2020 C4591001 1085 10851090 43 Female 167.64 81.82 29 White Non-Hispanic/non- Latino12AUG2020 C4591001 1085 10851098 51 Female 172.72 78.18 26.1 White Non-Hispanic/non- Latino13AUG2020 C4591001 1085 10851099 32 Female 151.13 72.73 31.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1087 10871007 46 Male 152.4 77.5 33.4 White Non-Hispanic/non- Latino07AUG2020 C4591001 1087 10871010 50 Female 160.02 67.13 26.2 White Non-Hispanic/non- Latino07AUG2020 C4591001 1087 10871020 52 Female 157.48 94.7 38.2 White Non-Hispanic/non- Latino07AUG2020 C4591001 1087 10871021 18 Female 166 85.82 31.1 White Non-Hispanic/non- Latino07AUG2020 C4591001 1087 10871028 54 Female 165.1 103.9 38.1 White Non-Hispanic/non- Latino07AUG2020 C4591001 1087 10871035 36 Female 162.56 100 37.8 White Non-Hispanic/non- Latino08AUG2020 C4591001 1087 10871041 39 Male 185.42 81.2 23.6 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1087 10871042 46 Female 167.64 114.16 40.6 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1087 10871045 51 Female 149.8 84.4 37.6 White Non-Hispanic/non- Latino10AUG2020 C4591001 1087 10871046 34 Female 167.6 144.1 51.3 Black or African American Non-Hispanic/non- Latino10AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 83 FDA-CBER-2021-5683-0032453 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1087 10871052 45 Male 177.8 109.6 34.7 White Non-Hispanic/non- Latino10AUG2020 C4591001 1087 10871053 50 Male 180.33 88.1 27.1 White Non-Hispanic/non- Latino11AUG2020 C4591001 1087 10871059 34 Male 172.5 74.2 24.9 Asian Non-Hispanic/non- Latino11AUG2020 C4591001 1087 10871060 24 Male 180.34 83 25.5 White Hispanic/Latino 11AUG2020 C4591001 1087 10871061 22 Female 157.48 59.7 24.1 White Hispanic/Latino 11AUG2020 C4591001 1087 10871062 23 Female 165.5 79 28.8 White Non-Hispanic/non- Latino11AUG2020 C4591001 1087 10871064 22 Female 157.48 61.41 24.8 White Non-Hispanic/non- Latino11AUG2020 C4591001 1087 10871065 50 Female 175.26 106.68 34.7 White Non-Hispanic/non- Latino11AUG2020 C4591001 1087 10871066 51 Male 190.5 135.8 37.4 White Non-Hispanic/non- Latino11AUG2020 C4591001 1087 10871067 44 Male 187.9 87.6 24.8 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1087 10871068 44 Male 185.42 115.2 33.5 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1087 10871074 50 Female 166.37 67.63 24.4 White Non-Hispanic/non- Latino11AUG2020 C4591001 1087 10871076 34 Female 157.48 53.63 21.6 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1087 10871078 23 Male 186.5 90.6 26 White Non-Hispanic/non- Latino12AUG2020 C4591001 1088 10881005 40 Female 170 62.5 21.6 White Non-Hispanic/non- Latino12AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 84 FDA-CBER-2021-5683-0032454 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1088 10881009 54 Female 158.5 91.5 36.4 White Non-Hispanic/non- Latino12AUG2020 C4591001 1088 10881010 50 Male 177.9 80.2 25.3 Black or African American Non-Hispanic/non- Latino12AUG2020 C4591001 1088 10881011 48 Female 171.5 64.2 21.8 White Non-Hispanic/non- Latino12AUG2020 C4591001 1088 10881012 39 Female 174.5 111 36.5 White Non-Hispanic/non- Latino12AUG2020 C4591001 1088 10881016 50 Female 165.1 133.81 49.1 White Non-Hispanic/non- Latino13AUG2020 C4591001 1088 10881017 54 Female 161 62.2 24 White Non-Hispanic/non- Latino13AUG2020 C4591001 1088 10881019 39 Male 174 83.9 27.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1088 10881021 38 Female 162 79.3 30.2 White Non-Hispanic/non- Latino13AUG2020 C4591001 1088 10881024 32 Female 168.5 81.8 28.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1088 10881025 55 Male 168 78.6 27.8 White Non-Hispanic/non- Latino14AUG2020 C4591001 1088 10881036 49 Female 164.5 142.9 52.8 Black or African American Non-Hispanic/non- Latino14AUG2020 C4591001 1088 10881037 53 Male 175.5 86.2 28 White Non-Hispanic/non- Latino15AUG2020 C4591001 1088 10881038 44 Female 164.5 65.1 24.1 White Non-Hispanic/non- Latino15AUG2020 C4591001 1088 10881039 38 Female 175 91.6 29.9 White Non-Hispanic/non- Latino15AUG2020 C4591001 1088 10881040 30 Female 166.8 115.5 41.5 White Non-Hispanic/non- Latino15AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 85 FDA-CBER-2021-5683-0032455 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1088 10881128 39 Male 176.5 85.7 27.5 White Non-Hispanic/non- Latino01SEP2020 C4591001 1089 10891020 54 Male 188.21 108.55 30.6 White Non-Hispanic/non- Latino31JUL2020 C4591001 1089 10891022 47 Female 157.48 71.45 28.7 Black or African American Non-Hispanic/non- Latino31JUL2020 C4591001 1089 10891025 27 Male 184.4 66.18 19.4 White Non-Hispanic/non- Latino31JUL2020 C4591001 1089 10891027 50 Female 167.64 109.55 38.9 White Non-Hispanic/non- Latino31JUL2020 C4591001 1089 10891029 33 Male 170.69 73.55 25.2 White Non-Hispanic/non- Latino03AUG2020 C4591001 1089 10891049 54 Male 177.8 112 35.4 White Non-Hispanic/non- Latino04AUG2020 C4591001 1089 10891050 31 Female 160.02 90.82 35.4 White Non-Hispanic/non- Latino04AUG2020 C4591001 1089 10891054 27 Female 172.72 91.55 30.6 Black or African American Non-Hispanic/non- Latino04AUG2020 C4591001 1089 10891055 46 Female 160.02 63.36 24.7 White Non-Hispanic/non- Latino04AUG2020 C4591001 1089 10891056 33 Female 162.56 91.36 34.5 White Non-Hispanic/non- Latino04AUG2020 C4591001 1089 10891057 49 Female 171.45 100.18 34 White Non-Hispanic/non- Latino04AUG2020 C4591001 1089 10891058 53 Female 157.48 63.64 25.6 White Non-Hispanic/non- Latino05AUG2020 C4591001 1089 10891059 55 Male 182.88 111.36 33.2 Black or African American Non-Hispanic/non- Latino05AUG2020 C4591001 1089 10891061 27 Female 161.04 53.45 20.6 White Non-Hispanic/non- Latino05AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 86 FDA-CBER-2021-5683-0032456 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1089 10891062 52 Female 168.66 122.36 42.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1089 10891064 55 Male 191.77 84.23 22.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1089 10891065 47 Female 154.94 66 27.4 White Non-Hispanic/non- Latino05AUG2020 C4591001 1089 10891067 54 Male 180.34 94.55 29 White Non-Hispanic/non- Latino06AUG2020 C4591001 1089 10891070 46 Female 167.64 87 30.9 White Non-Hispanic/non- Latino06AUG2020 C4591001 1089 10891072 35 Female 176.28 126.82 40.7 White Non-Hispanic/non- Latino06AUG2020 C4591001 1089 10891074 51 Female 175.26 125.45 40.8 White Non-Hispanic/non- Latino06AUG2020 C4591001 1089 10891076 38 Male 170.18 76.41 26.3 White Non-Hispanic/non- Latino06AUG2020 C4591001 1089 10891077 55 Female 172.72 100 33.4 White Non-Hispanic/non- Latino06AUG2020 C4591001 1089 10891078 27 Male 185.93 166.55 48.1 White Non-Hispanic/non- Latino06AUG2020 C4591001 1089 10891079 36 Female 164.59 66.09 24.3 White Non-Hispanic/non- Latino06AUG2020 C4591001 1089 10891080 36 Female 154.94 57.27 23.8 White Non-Hispanic/non- Latino06AUG2020 C4591001 1089 10891082 33 Female 154.94 61.09 25.4 Black or African American Non-Hispanic/non- Latino07AUG2020 C4591001 1089 10891084 42 Female 163.83 71.09 26.4 White Non-Hispanic/non- Latino07AUG2020 C4591001 1089 10891091 51 Male 182.88 132.64 39.6 Black or African American Non-Hispanic/non- Latino10AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 87 FDA-CBER-2021-5683-0032457 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1089 10891100 33 Female 162.56 38.45 14.5 White Non-Hispanic/non- Latino11AUG2020 C4591001 1089 10891101 29 Female 167.64 59.64 21.2 White Hispanic/Latino 11AUG2020 C4591001 1089 10891103 53 Male 185.42 93.32 27.1 White Non-Hispanic/non- Latino11AUG2020 C4591001 1089 10891105 46 Male 177.8 102.32 32.3 White Non-Hispanic/non- Latino11AUG2020 C4591001 1089 10891106 52 Male 182.63 117.91 35.3 White Non-Hispanic/non- Latino11AUG2020 C4591001 1089 10891107 44 Female 169.42 61.73 21.5 White Non-Hispanic/non- Latino12AUG2020 C4591001 1089 10891111 48 Female 172.72 82.55 27.6 White Non-Hispanic/non- Latino12AUG2020 C4591001 1089 10891113 49 Female 152.4 52.36 22.5 White Non-Hispanic/non- Latino12AUG2020 C4591001 1089 10891114 27 Female 165.1 63.68 23.3 White Non-Hispanic/non- Latino12AUG2020 C4591001 1089 10891115 55 Male 180.34 104.59 32.1 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1089 10891116 38 Female 160.02 73.73 28.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1089 10891119 30 Male 172.72 73.64 24.6 White Non-Hispanic/non- Latino13AUG2020 C4591001 1089 10891120 24 Male 172.21 77.55 26.1 White Non-Hispanic/non- Latino13AUG2020 C4591001 1089 10891121 21 Female 173.99 139.45 46 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1089 10891123 41 Male 175.26 80.73 26.2 Black or African American Non-Hispanic/non- Latino14AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 88 FDA-CBER-2021-5683-0032458 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1089 10891130 55 Female 162.56 58 21.9 White Non-Hispanic/non- Latino14AUG2020 C4591001 1090 10901001 30 Male 180.3 96.5 29.7 White Non-Hispanic/non- Latino31JUL2020 C4591001 1090 10901002 40 Male 180.3 84.3 25.9 White Non-Hispanic/non- Latino31JUL2020 C4591001 1090 10901005 45 Male 185 110.8 32.4 White Non-Hispanic/non- Latino31JUL2020 C4591001 1090 10901006 44 Female 171.5 91.6 31.1 White Non-Hispanic/non- Latino31JUL2020 C4591001 1090 10901007 51 Male 167.5 67.6 24.1 Asian Non-Hispanic/non- Latino31JUL2020 C4591001 1090 10901008 47 Male 172.8 88 29.5 White Non-Hispanic/non- Latino31JUL2020 C4591001 1090 10901009 31 Male 178 92.4 29.2 White Non-Hispanic/non- Latino31JUL2020 C4591001 1090 10901012 50 Male 177.75 105 33.2 Black or African American Non-Hispanic/non- Latino31JUL2020 C4591001 1090 10901014 31 Female 160 72.2 28.2 White Non-Hispanic/non- Latino03AUG2020 C4591001 1090 10901015 38 Female 170 88.4 30.6 Black or African American Non-Hispanic/non- Latino03AUG2020 C4591001 1090 10901016 55 Male 180.3 95.7 29.4 Black or African American Non-Hispanic/non- Latino03AUG2020 C4591001 1090 10901020 37 Female 160.5 72.5 28.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1090 10901021 36 Female 152.4 70 30.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1090 10901022 52 Female 167 77.4 27.8 White Non-Hispanic/non- Latino03AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 89 FDA-CBER-2021-5683-0032459 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1090 10901023 46 Male 167 73.4 26.3 White Non-Hispanic/non- Latino03AUG2020 C4591001 1090 10901024 26 Male 185 86 25.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1090 10901029 42 Male 182.9 97.7 29.2 White Hispanic/Latino 03AUG2020 C4591001 1090 10901031 23 Female 164.3 59.2 21.9 White Non-Hispanic/non- Latino03AUG2020 C4591001 1090 10901034 30 Male 180 81.2 25.1 White Non-Hispanic/non- Latino04AUG2020 C4591001 1090 10901035 53 Male 179.8 69.9 21.6 Black or African American Non-Hispanic/non- Latino04AUG2020 C4591001 1090 10901037 38 Female 167.6 79.4 28.3 White Non-Hispanic/non- Latino04AUG2020 C4591001 1090 10901038 20 Female 172.5 66.9 22.5 White Non-Hispanic/non- Latino04AUG2020 C4591001 1090 10901039 54 Female 165.1 72.7 26.7 White Non-Hispanic/non- Latino04AUG2020 C4591001 1090 10901043 21 Female 152.9 82.3 35.2 White Non-Hispanic/non- Latino04AUG2020 C4591001 1090 10901044 24 Female 160 89.7 35 White Non-Hispanic/non- Latino04AUG2020 C4591001 1090 10901045 26 Female 168.9 62.1 21.8 White Non-Hispanic/non- Latino04AUG2020 C4591001 1090 10901046 31 Female 162.6 84.5 32 White Non-Hispanic/non- Latino04AUG2020 C4591001 1090 10901047 50 Male 167.4 98.8 35.3 White Non-Hispanic/non- Latino04AUG2020 C4591001 1090 10901049 28 Female 160 58.4 22.8 Asian Non-Hispanic/non- Latino04AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 90 FDA-CBER-2021-5683-0032460 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1090 10901050 34 Male 175.5 72.6 23.6 White Non-Hispanic/non- Latino04AUG2020 C4591001 1090 10901051 41 Male 183 89.3 26.7 White Non-Hispanic/non- Latino04AUG2020 C4591001 1090 10901052 29 Female 160 63.5 24.8 White Non-Hispanic/non- Latino04AUG2020 C4591001 1090 10901058 38 Male 172.7 72.6 24.3 White Hispanic/Latino 05AUG2020 C4591001 1090 10901061 39 Male 177.8 90.9 28.8 White Non-Hispanic/non- Latino05AUG2020 C4591001 1090 10901065 53 Female 170.1 70.5 24.4 White Non-Hispanic/non- Latino05AUG2020 C4591001 1090 10901067 38 Male 172.7 72.7 24.4 Black or African American Non-Hispanic/non- Latino05AUG2020 C4591001 1090 10901068 41 Female 167.6 91.5 32.6 Black or African American Non-Hispanic/non- Latino05AUG2020 C4591001 1090 10901070 34 Female 161 62.7 24.2 White Non-Hispanic/non- Latino05AUG2020 C4591001 1090 10901072 55 Female 172.7 79.5 26.7 White Non-Hispanic/non- Latino05AUG2020 C4591001 1090 10901073 51 Female 169 112 39.2 White Non-Hispanic/non- Latino05AUG2020 C4591001 1090 10901074 49 Male 167.6 123.6 44 White Non-Hispanic/non- Latino05AUG2020 C4591001 1090 10901076 40 Male 175.8 82.1 26.6 Asian Non-Hispanic/non- Latino06AUG2020 C4591001 1090 10901079 33 Female 151.9 60.7 26.3 Asian Non-Hispanic/non- Latino06AUG2020 C4591001 1090 10901081 35 Male 186 91.6 26.5 White Non-Hispanic/non- Latino06AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 91 FDA-CBER-2021-5683-0032461 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1090 10901086 55 Male 177.8 81.4 25.7 White Non-Hispanic/non- Latino06AUG2020 C4591001 1090 10901088 51 Male 177 101.6 32.4 Black or African American Non-Hispanic/non- Latino06AUG2020 C4591001 1090 10901090 25 Male 173 98.8 33 Multiracial Non-Hispanic/non- Latino06AUG2020 C4591001 1090 10901094 43 Female 160.5 97.4 37.8 White Non-Hispanic/non- Latino07AUG2020 C4591001 1090 10901095 40 Male 174 74.2 24.5 White Non-Hispanic/non- Latino07AUG2020 C4591001 1090 10901096 51 Female 162.56 50 18.9 Asian Non-Hispanic/non- Latino07AUG2020 C4591001 1090 10901097 37 Male 175.2 77 25.1 Black or African American Non-Hispanic/non- Latino07AUG2020 C4591001 1090 10901099 49 Female 167.64 49.3 17.5 White Non-Hispanic/non- Latino07AUG2020 C4591001 1090 10901101 41 Male 179.5 134 41.6 White Non-Hispanic/non- Latino07AUG2020 C4591001 1090 10901103 31 Female 170 66.5 23 White Non-Hispanic/non- Latino07AUG2020 C4591001 1090 10901104 50 Female 166.5 65.5 23.6 White Non-Hispanic/non- Latino07AUG2020 C4591001 1090 10901105 45 Male 172.7 73.8 24.7 Asian Non-Hispanic/non- Latino07AUG2020 C4591001 1090 10901106 49 Male 177 127.8 40.8 White Non-Hispanic/non- Latino07AUG2020 C4591001 1090 10901109 38 Male 183.6 86.9 25.8 White Non-Hispanic/non- Latino07AUG2020 C4591001 1090 10901111 35 Male 167.6 68 24.2 White Non-Hispanic/non- Latino07AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 92 FDA-CBER-2021-5683-0032462 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1090 10901112 38 Female 165.2 67.8 24.8 White Non-Hispanic/non- Latino07AUG2020 C4591001 1090 10901114 33 Female 157.4 56.6 22.8 White Non-Hispanic/non- Latino07AUG2020 C4591001 1090 10901115 37 Male 180 68.2 21 White Non-Hispanic/non- Latino07AUG2020 C4591001 1090 10901116 48 Male 178 112.4 35.5 White Non-Hispanic/non- Latino10AUG2020 C4591001 1090 10901125 50 Female 156 67.2 27.6 White Non-Hispanic/non- Latino10AUG2020 C4591001 1090 10901131 43 Male 190.5 147.8 40.7 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1090 10901132 42 Male 185 99.9 29.2 Black or African American Hispanic/Latino 11AUG2020 C4591001 1090 10901133 39 Female 171.5 94.5 32.1 White Not reported 11AUG2020 C4591001 1090 10901135 53 Female 167.6 108.9 38.8 Black or African American Non-Hispanic/non- Latino11AUG2020 C4591001 1090 10901136 32 Female 176 59.2 19.1 White Non-Hispanic/non- Latino11AUG2020 C4591001 1090 10901139 45 Male 177 81.7 26.1 White Non-Hispanic/non- Latino11AUG2020 C4591001 1090 10901140 44 Female 165 124 45.5 White Non-Hispanic/non- Latino11AUG2020 C4591001 1090 10901147 48 Female 157.4 139.7 56.4 Black or African American Hispanic/Latino 12AUG2020 C4591001 1090 10901154 33 Female 171 94.8 32.4 White Non-Hispanic/non- Latino12AUG2020 C4591001 1090 10901156 53 Female 152 66 28.6 White Non-Hispanic/non- Latino12AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 93 FDA-CBER-2021-5683-0032463 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1090 10901157 24 Female 162.56 49.09 18.5 White Non-Hispanic/non- Latino12AUG2020 C4591001 1090 10901160 44 Female 171 92.7 31.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1090 10901161 46 Female 168.7 60.3 21.2 Asian Non-Hispanic/non- Latino13AUG2020 C4591001 1090 10901163 49 Male 174 90.5 29.9 White Non-Hispanic/non- Latino13AUG2020 C4591001 1090 10901167 40 Female 163 55.3 20.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1090 10901169 49 Female 172.4 139.5 46.9 White Non-Hispanic/non- Latino13AUG2020 C4591001 1090 10901172 40 Female 172.8 68.2 22.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1090 10901174 45 Female 165 57.8 21.2 White Hispanic/Latino 13AUG2020 C4591001 1090 10901177 51 Female 170 90.5 31.3 White Non-Hispanic/non- Latino13AUG2020 C4591001 1090 10901178 51 Female 165.1 101.1 37.1 White Non-Hispanic/non- Latino13AUG2020 C4591001 1090 10901185 50 Female 156 47.4 19.5 White Non-Hispanic/non- Latino14AUG2020 C4591001 1090 10901193 51 Male 183 83 24.8 White Non-Hispanic/non- Latino14AUG2020 C4591001 1090 10901197 19 Male 182.9 69 20.6 White Non-Hispanic/non- Latino14AUG2020 C4591001 1090 10901200 44 Female 166 74 26.9 White Not reported 14AUG2020 C4591001 1090 10901201 20 Female 165.1 90.1 33.1 White Non-Hispanic/non- Latino14AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 94 FDA-CBER-2021-5683-0032464 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1090 10901245 33 Female 158 67.6 27.1 White Hispanic/Latino 18AUG2020 C4591001 1091 10911005 55 Female 150.1 80.2 35.6 White Non-Hispanic/non- Latino30JUL2020 C4591001 1091 10911008 53 Male 184.5 105.1 30.9 White Not reported 31JUL2020 C4591001 1091 10911011 41 Female 143.5 75.3 36.6 White Non-Hispanic/non- Latino31JUL2020 C4591001 1091 10911013 52 Male 172 130.8 44.2 White Non-Hispanic/non- Latino31JUL2020 C4591001 1091 10911014 52 Male 172.4 122.1 41.1 White Non-Hispanic/non- Latino31JUL2020 C4591001 1091 10911015 51 Female 161 79.8 30.8 White Non-Hispanic/non- Latino31JUL2020 C4591001 1091 10911017 46 Female 162.56 85.5 32.4 White Non-Hispanic/non- Latino03AUG2020 C4591001 1091 10911019 20 Female 174 57.2 18.9 White Non-Hispanic/non- Latino03AUG2020 C4591001 1091 10911020 21 Female 162.5 53.8 20.4 White Non-Hispanic/non- Latino03AUG2020 C4591001 1091 10911022 44 Male 168.3 77.7 27.4 White Non-Hispanic/non- Latino03AUG2020 C4591001 1091 10911025 34 Female 165.5 60.6 22.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1091 10911027 53 Female 163.83 63.3 23.6 White Non-Hispanic/non- Latino04AUG2020 C4591001 1091 10911032 50 Male 184 107.6 31.8 White Non-Hispanic/non- Latino04AUG2020 C4591001 1091 10911033 51 Male 173.6 105.1 34.9 Black or African American Non-Hispanic/non- Latino04AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 95 FDA-CBER-2021-5683-0032465 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1091 10911037 47 Male 177 91.5 29.2 White Not reported 04AUG2020 C4591001 1091 10911038 44 Male 190 126.7 35.1 White Non-Hispanic/non- Latino04AUG2020 C4591001 1091 10911039 29 Male 180 98.8 30.5 White Hispanic/Latino 04AUG2020 C4591001 1091 10911042 26 Male 182 79.1 23.9 White Non-Hispanic/non- Latino04AUG2020 C4591001 1091 10911043 47 Female 162.5 68.2 25.8 White Non-Hispanic/non- Latino04AUG2020 C4591001 1091 10911046 50 Male 180.8 86.3 26.4 White Non-Hispanic/non- Latino04AUG2020 C4591001 1091 10911051 26 Male 181.3 89.2 27.1 White Non-Hispanic/non- Latino05AUG2020 C4591001 1091 10911052 49 Male 175 114.7 37.5 White Non-Hispanic/non- Latino05AUG2020 C4591001 1091 10911053 32 Female 167 61.8 22.2 Asian Non-Hispanic/non- Latino05AUG2020 C4591001 1091 10911054 31 Male 176.1 78.8 25.4 White Non-Hispanic/non- Latino05AUG2020 C4591001 1091 10911057 31 Male 177.4 65.8 20.9 Asian Non-Hispanic/non- Latino05AUG2020 C4591001 1091 10911058 41 Male 170 90.8 31.4 White Non-Hispanic/non- Latino05AUG2020 C4591001 1091 10911061 44 Female 169.3 65.1 22.7 White Non-Hispanic/non- Latino05AUG2020 C4591001 1091 10911062 44 Female 154 48.8 20.6 White Hispanic/Latino 05AUG2020 C4591001 1091 10911065 49 Female 156.2 70.8 29 White Non-Hispanic/non- Latino05AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 96 FDA-CBER-2021-5683-0032466 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1091 10911066 54 Male 175.26 163.5 53.2 White Non-Hispanic/non- Latino06AUG2020 C4591001 1091 10911067 23 Female 169 92.6 32.4 White Non-Hispanic/non- Latino06AUG2020 C4591001 1091 10911069 53 Female 167 122.2 43.8 White Non-Hispanic/non- Latino06AUG2020 C4591001 1091 10911070 43 Female 161.3 72.7 27.9 White Non-Hispanic/non- Latino06AUG2020 C4591001 1091 10911072 36 Male 181.5 81.5 24.7 White Non-Hispanic/non- Latino06AUG2020 C4591001 1091 10911075 53 Female 165.5 87.4 31.9 White Non-Hispanic/non- Latino06AUG2020 C4591001 1091 10911077 31 Male 172.8 65.5 21.9 White Non-Hispanic/non- Latino06AUG2020 C4591001 1091 10911078 41 Female 161.3 103.4 39.7 White Non-Hispanic/non- Latino06AUG2020 C4591001 1091 10911079 45 Female 176 66.1 21.3 White Non-Hispanic/non- Latino06AUG2020 C4591001 1091 10911082 54 Male 181.5 133.2 40.4 Black or African American Non-Hispanic/non- Latino06AUG2020 C4591001 1091 10911083 54 Male 176 72.4 23.4 Asian Non-Hispanic/non- Latino06AUG2020 C4591001 1091 10911085 38 Female 169 69.9 24.5 Black or African American Non-Hispanic/non- Latino06AUG2020 C4591001 1091 10911087 41 Female 176 70 22.6 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1091 10911088 18 Male 177.9 83.9 26.5 White Non-Hispanic/non- Latino10AUG2020 C4591001 1091 10911090 55 Male 165.5 67.2 24.5 White Non-Hispanic/non- Latino10AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 97 FDA-CBER-2021-5683-0032467 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1091 10911091 31 Male 182.9 86.3 25.8 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1091 10911093 26 Male 189.5 75.3 21 White Not reported 10AUG2020 C4591001 1091 10911095 22 Male 180.34 99.5 30.6 Asian Non-Hispanic/non- Latino11AUG2020 C4591001 1091 10911096 27 Male 177.5 84.5 26.8 White Non-Hispanic/non- Latino11AUG2020 C4591001 1091 10911098 37 Male 173.9 88.8 29.4 White Non-Hispanic/non- Latino11AUG2020 C4591001 1091 10911099 38 Male 178 89.3 28.2 White Non-Hispanic/non- Latino11AUG2020 C4591001 1091 10911103 49 Male 178.5 86.3 27.1 White Non-Hispanic/non- Latino11AUG2020 C4591001 1091 10911104 40 Female 168.91 102.4 35.9 White Non-Hispanic/non- Latino12AUG2020 C4591001 1091 10911106 22 Male 173.75 71.2 23.6 Multiracial Non-Hispanic/non- Latino12AUG2020 C4591001 1091 10911107 49 Female 166.5 67.6 24.4 White Non-Hispanic/non- Latino12AUG2020 C4591001 1091 10911108 47 Male 184 83.8 24.8 White Non-Hispanic/non- Latino12AUG2020 C4591001 1091 10911111 23 Female 158.5 70.6 28.1 White Non-Hispanic/non- Latino12AUG2020 C4591001 1091 10911113 40 Male 184.1 111.1 32.8 White Non-Hispanic/non- Latino13AUG2020 C4591001 1091 10911116 53 Female 170 60.6 21 White Non-Hispanic/non- Latino13AUG2020 C4591001 1091 10911118 38 Male 187.4 78.5 22.4 White Non-Hispanic/non- Latino13AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 98 FDA-CBER-2021-5683-0032468 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1091 10911119 44 Female 173.1 86.9 29 White Non-Hispanic/non- Latino13AUG2020 C4591001 1091 10911120 23 Female 161 63.2 24.4 White Non-Hispanic/non- Latino13AUG2020 C4591001 1091 10911121 54 Female 165 73.5 27 White Non-Hispanic/non- Latino13AUG2020 C4591001 1091 10911122 25 Female 169.5 123.3 42.9 White Non-Hispanic/non- Latino13AUG2020 C4591001 1093 10931001 38 Female 171.45 74.55 25.3 White Non-Hispanic/non- Latino15AUG2020 C4591001 1093 10931002 39 Female 157.48 96.09 38.7 White Non-Hispanic/non- Latino15AUG2020 C4591001 1093 10931003 40 Female 166.37 51.82 18.7 White Non-Hispanic/non- Latino15AUG2020 C4591001 1093 10931006 39 Male 191.77 108.18 29.4 White Non-Hispanic/non- Latino15AUG2020 C4591001 1093 10931007 39 Female 163.83 81.18 30.2 White Non-Hispanic/non- Latino15AUG2020 C4591001 1094 10941004 55 Female 158 72.3 29 White Hispanic/Latino 12AUG2020 C4591001 1094 10941010 49 Male 165 69.1 25.4 White Hispanic/Latino 13AUG2020 C4591001 1094 10941016 54 Female 161 72.6 28 White Hispanic/Latino 14AUG2020 C4591001 1094 10941017 46 Male 187.2 83.7 23.9 Black or African American Non-Hispanic/non- Latino14AUG2020 C4591001 1095 10951008 51 Female 166 57.3 20.8 Asian Non-Hispanic/non- Latino30JUL2020 C4591001 1095 10951009 38 Female 173 81.6 27.3 White Non-Hispanic/non- Latino31JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 99 FDA-CBER-2021-5683-0032469 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1095 10951011 44 Female 166 55.6 20.2 White Non-Hispanic/non- Latino31JUL2020 C4591001 1095 10951014 36 Female 166.5 64.9 23.4 White Non-Hispanic/non- Latino31JUL2020 C4591001 1095 10951018 28 Female 162 79 30.1 White Hispanic/Latino 31JUL2020 C4591001 1095 10951021 55 Male 178.5 88.4 27.7 White Non-Hispanic/non- Latino03AUG2020 C4591001 1095 10951022 54 Female 170 135.8 47 White Non-Hispanic/non- Latino03AUG2020 C4591001 1095 10951023 50 Female 165 102.7 37.7 White Non-Hispanic/non- Latino03AUG2020 C4591001 1095 10951024 38 Male 170.18 70 24.2 Asian Non-Hispanic/non- Latino03AUG2020 C4591001 1095 10951025 30 Female 152.5 73.7 31.7 White Hispanic/Latino 03AUG2020 C4591001 1095 10951026 37 Male 177.5 68.1 21.6 White Non-Hispanic/non- Latino03AUG2020 C4591001 1095 10951028 34 Female 170.5 84.7 29.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1095 10951029 40 Female 163 71.3 26.8 White Non-Hispanic/non- Latino03AUG2020 C4591001 1095 10951030 29 Male 162.56 63 23.8 White Hispanic/Latino 03AUG2020 C4591001 1095 10951031 49 Male 166 72.3 26.2 White Non-Hispanic/non- Latino03AUG2020 C4591001 1095 10951033 50 Male 182 85.3 25.8 White Non-Hispanic/non- Latino03AUG2020 C4591001 1095 10951034 30 Female 151.5 57 24.8 White Hispanic/Latino 03AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 100 FDA-CBER-2021-5683-0032470 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1095 10951036 31 Male 171 83.4 28.5 White Non-Hispanic/non- Latino03AUG2020 C4591001 1095 10951038 21 Male 186 95.2 27.5 White Non-Hispanic/non- Latino03AUG2020 C4591001 1095 10951039 54 Male 173.5 86.3 28.7 White Non-Hispanic/non- Latino03AUG2020 C4591001 1095 10951040 52 Female 163.5 109.3 40.9 White Hispanic/Latino 04AUG2020 C4591001 1095 10951042 46 Male 175 67.1 21.9 Asian Non-Hispanic/non- Latino04AUG2020 C4591001 1095 10951044 51 Female 172.5 63.4 21.3 White Hispanic/Latino 04AUG2020 C4591001 1095 10951045 51 Female 160.5 60.6 23.5 White Non-Hispanic/non- Latino04AUG2020 C4591001 1095 10951046 23 Male 169.5 92 32 White Hispanic/Latino 04AUG2020 C4591001 1095 10951047 31 Male 175 90.5 29.6 White Non-Hispanic/non- Latino04AUG2020 C4591001 1095 10951055 25 Female 160.5 64.5 25 White Hispanic/Latino 04AUG2020 C4591001 1095 10951056 22 Female 155 96.1 40 Black or African American Non-Hispanic/non- Latino05AUG2020 C4591001 1095 10951057 46 Female 184 81.8 24.2 White Non-Hispanic/non- Latino05AUG2020 C4591001 1095 10951058 35 Male 177.8 114.5 36.2 White Hispanic/Latino 05AUG2020 C4591001 1095 10951059 55 Male 178.5 82.3 25.8 White Non-Hispanic/non- Latino05AUG2020 C4591001 1095 10951060 36 Male 169.5 78 27.1 Not reported Non-Hispanic/non- Latino05AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 101 FDA-CBER-2021-5683-0032471 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1095 10951061 36 Female 165 85.6 31.4 White Non-Hispanic/non- Latino05AUG2020 C4591001 1095 10951062 35 Male 175 87.4 28.5 White Non-Hispanic/non- Latino05AUG2020 C4591001 1095 10951066 33 Female 158.5 71.6 28.5 White Hispanic/Latino 05AUG2020 C4591001 1095 10951069 42 Male 192 76.3 20.7 White Non-Hispanic/non- Latino06AUG2020 C4591001 1095 10951070 36 Male 168 76.8 27.2 White Hispanic/Latino 06AUG2020 C4591001 1095 10951073 43 Female 172 100.4 33.9 White Non-Hispanic/non- Latino06AUG2020 C4591001 1095 10951074 38 Female 172.72 67.1 22.5 White Non-Hispanic/non- Latino06AUG2020 C4591001 1095 10951076 48 Female 160 105.3 41.1 White Non-Hispanic/non- Latino06AUG2020 C4591001 1095 10951083 53 Male 181 114.8 35 White Non-Hispanic/non- Latino06AUG2020 C4591001 1095 10951084 50 Male 168 71.8 25.4 Asian Non-Hispanic/non- Latino06AUG2020 C4591001 1095 10951087 50 Male 167.64 87.4 31.1 White Non-Hispanic/non- Latino06AUG2020 C4591001 1095 10951089 42 Male 185.5 93.5 27.2 White Non-Hispanic/non- Latino06AUG2020 C4591001 1095 10951090 41 Male 178 88.7 28 Black or African American Non-Hispanic/non- Latino06AUG2020 C4591001 1095 10951091 43 Female 165.5 83.9 30.6 White Non-Hispanic/non- Latino06AUG2020 C4591001 1095 10951092 51 Female 157 52.1 21.1 White Non-Hispanic/non- Latino06AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 102 FDA-CBER-2021-5683-0032472 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1095 10951093 42 Female 175 84.1 27.5 White Non-Hispanic/non- Latino07AUG2020 C4591001 1095 10951094 29 Female 173.5 53.9 17.9 Asian Non-Hispanic/non- Latino07AUG2020 C4591001 1095 10951095 31 Male 184.5 104.1 30.6 White Hispanic/Latino 07AUG2020 C4591001 1095 10951096 29 Female 156 60.9 25 White Hispanic/Latino 07AUG2020 C4591001 1095 10951106 23 Male 167 61.4 22 White Hispanic/Latino 07AUG2020 C4591001 1096 10961007 55 Female 168.91 64.18 22.4 White Non-Hispanic/non- Latino13AUG2020 C4591001 1096 10961010 21 Female 161.29 89.56 34.4 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1096 10961011 26 Male 167.64 65.48 23.2 White Hispanic/Latino 13AUG2020 C4591001 1096 10961012 27 Male 167.64 106 37.6 White Hispanic/Latino 13AUG2020 C4591001 1096 10961013 54 Male 180.34 84.11 25.8 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1096 10961018 42 Female 161.29 92.36 35.4 White Hispanic/Latino 13AUG2020 C4591001 1096 10961022 35 Female 161.29 128.82 49.4 White Non-Hispanic/non- Latino14AUG2020 C4591001 1096 10961023 50 Male 167.39 98.82 35.2 White Non-Hispanic/non- Latino14AUG2020 C4591001 1096 10961029 46 Male 179.07 92.45 28.8 White Non-Hispanic/non- Latino14AUG2020 C4591001 1096 10961030 24 Male 170.18 75.18 25.9 Asian Non-Hispanic/non- Latino14AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 103 FDA-CBER-2021-5683-0032473 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1107 11071012 29 Male 187.96 116.18 32.8 Asian Non-Hispanic/non- Latino03AUG2020 C4591001 1107 11071013 31 Female 182.88 89.09 26.6 Asian Non-Hispanic/non- Latino03AUG2020 C4591001 1107 11071015 28 Male 186.69 91.36 26.2 White Non-Hispanic/non- Latino03AUG2020 C4591001 1107 11071016 55 Male 180.34 91.82 28.2 Black or African American Non-Hispanic/non- Latino03AUG2020 C4591001 1107 11071018 35 Female 172.72 136.73 45.7 Black or African American Non-Hispanic/non- Latino03AUG2020 C4591001 1107 11071019 47 Female 168.91 64.55 22.6 White Non-Hispanic/non- Latino03AUG2020 C4591001 1107 11071020 33 Male 185.42 101.18 29.4 White Non-Hispanic/non- Latino03AUG2020 C4591001 1107 11071022 54 Female 165.1 50.27 18.4 White Non-Hispanic/non- Latino03AUG2020 C4591001 1107 11071025 25 Male 189.23 92.73 25.8 White Non-Hispanic/non- Latino03AUG2020 C4591001 1107 11071026 47 Male 191.77 179.91 48.8 Black or African American Non-Hispanic/non- Latino04AUG2020 C4591001 1107 11071027 46 Male 187.96 83.64 23.6 White Non-Hispanic/non- Latino04AUG2020 C4591001 1107 11071028 53 Female 168.91 64.18 22.4 White Non-Hispanic/non- Latino04AUG2020 C4591001 1107 11071031 48 Female 162.56 73.18 27.6 White Non-Hispanic/non- Latino04AUG2020 C4591001 1107 11071032 45 Female 170.18 68.18 23.5 White Non-Hispanic/non- Latino04AUG2020 C4591001 1107 11071033 45 Female 165.1 79.09 29 Black or African American Non-Hispanic/non- Latino04AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 104 FDA-CBER-2021-5683-0032474 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1107 11071034 50 Male 190.5 83.64 23 Black or African American Non-Hispanic/non- Latino04AUG2020 C4591001 1107 11071039 44 Male 180.34 130 39.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1107 11071046 54 Female 168.91 65.45 22.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1107 11071049 35 Male 193.04 89.18 23.9 White Non-Hispanic/non- Latino05AUG2020 C4591001 1107 11071052 54 Female 167.64 75.27 26.7 White Non-Hispanic/non- Latino05AUG2020 C4591001 1107 11071054 51 Female 152.4 57.45 24.7 White Non-Hispanic/non- Latino06AUG2020 C4591001 1107 11071055 21 Male 184.15 80.45 23.7 White Non-Hispanic/non- Latino06AUG2020 C4591001 1107 11071056 48 Male 179.07 72.09 22.4 White Non-Hispanic/non- Latino06AUG2020 C4591001 1107 11071057 40 Female 161.29 130.45 50 Black or African American Non-Hispanic/non- Latino06AUG2020 C4591001 1107 11071059 46 Female 162.56 97.91 37 White Non-Hispanic/non- Latino06AUG2020 C4591001 1107 11071063 41 Female 170.18 82.27 28.3 Black or African American Non-Hispanic/non- Latino06AUG2020 C4591001 1107 11071065 43 Female 170.18 133.82 46.1 Black or African American Non-Hispanic/non- Latino06AUG2020 C4591001 1107 11071067 50 Male 177.8 89.27 28.2 Black or African American Non-Hispanic/non- Latino06AUG2020 C4591001 1107 11071069 46 Male 179.07 105.45 32.8 White Non-Hispanic/non- Latino06AUG2020 C4591001 1107 11071070 41 Female 165.1 61.73 22.6 White Non-Hispanic/non- Latino06AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 105 FDA-CBER-2021-5683-0032475 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1107 11071071 40 Female 163.83 70.45 26.2 White Non-Hispanic/non- Latino06AUG2020 C4591001 1107 11071072 51 Male 177.8 64.55 20.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1107 11071074 48 Male 203.2 159.95 38.7 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1107 11071079 50 Male 171.45 78.18 26.5 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1107 11071083 31 Male 181.61 95.45 28.9 White Non-Hispanic/non- Latino10AUG2020 C4591001 1107 11071086 37 Male 187.96 107.73 30.4 White Non-Hispanic/non- Latino11AUG2020 C4591001 1107 11071087 33 Female 162.56 70 26.4 White Not reported 11AUG2020 C4591001 1107 11071089 54 Female 161.29 68.27 26.2 White Non-Hispanic/non- Latino11AUG2020 C4591001 1107 11071096 45 Male 172.72 71.82 24 White Non-Hispanic/non- Latino12AUG2020 C4591001 1107 11071097 37 Female 171.45 75 25.5 White Non-Hispanic/non- Latino12AUG2020 C4591001 1107 11071098 37 Female 161.29 68.18 26.2 White Not reported 12AUG2020 C4591001 1107 11071102 47 Male 187.96 128.91 36.4 White Non-Hispanic/non- Latino13AUG2020 C4591001 1107 11071104 46 Female 168.91 77.73 27.2 White Non-Hispanic/non- Latino13AUG2020 C4591001 1107 11071105 50 Male 175.26 94.09 30.6 White Not reported 13AUG2020 C4591001 1107 11071106 55 Female 176.53 132.73 42.5 White Not reported 13AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 106 FDA-CBER-2021-5683-0032476 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1107 11071109 35 Female 160.02 60.91 23.7 White Non-Hispanic/non- Latino13AUG2020 C4591001 1107 11071110 53 Male 176.53 102.27 32.7 White Not reported 13AUG2020 C4591001 1107 11071111 39 Female 175.26 69.55 22.6 White Non-Hispanic/non- Latino13AUG2020 C4591001 1107 11071112 48 Female 170.18 81.82 28.2 White Non-Hispanic/non- Latino13AUG2020 C4591001 1109 11091041 55 Male 157.48 97.73 39.3 White Non-Hispanic/non- Latino31JUL2020 C4591001 1109 11091043 44 Male 185.42 97.73 28.4 White Non-Hispanic/non- Latino31JUL2020 C4591001 1109 11091046 20 Male 172.72 65.45 21.9 Black or African American Hispanic/Latino 31JUL2020 C4591001 1109 11091047 48 Female 160.02 89 34.7 White Hispanic/Latino 31JUL2020 C4591001 1109 11091048 45 Male 177.8 147.27 46.5 White Hispanic/Latino 31JUL2020 C4591001 1109 11091052 39 Male 182.88 90.91 27.1 White Hispanic/Latino 31JUL2020 C4591001 1109 11091054 45 Male 175.26 87.64 28.5 White Hispanic/Latino 31JUL2020 C4591001 1109 11091055 41 Female 167.64 57.64 20.5 American Indian or Alaska Native Non-Hispanic/non- Latino31JUL2020 C4591001 1109 11091056 31 Female 152.4 77.27 33.2 White Non-Hispanic/non- Latino31JUL2020 C4591001 1109 11091057 53 Female 165.1 100 36.6 White Non-Hispanic/non- Latino31JUL2020 C4591001 1109 11091058 48 Female 158.75 110.91 43.9 White Non-Hispanic/non- Latino31JUL2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 107 FDA-CBER-2021-5683-0032477 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1109 11091059 19 Male 185.42 76 22.1 White Non-Hispanic/non- Latino31JUL2020 C4591001 1109 11091060 31 Male 170.18 60.45 20.8 Black or African American Non-Hispanic/non- Latino31JUL2020 C4591001 1109 11091061 36 Male 190.5 101.09 27.8 White Non-Hispanic/non- Latino31JUL2020 C4591001 1109 11091062 35 Male 165.1 172.73 63.2 White Hispanic/Latino 31JUL2020 C4591001 1109 11091063 33 Female 177.8 108.18 34.1 White Non-Hispanic/non- Latino31JUL2020 C4591001 1109 11091066 48 Male 187.96 118.18 33.4 White Non-Hispanic/non- Latino31JUL2020 C4591001 1109 11091067 42 Male 175.26 88.64 28.8 White Non-Hispanic/non- Latino31JUL2020 C4591001 1109 11091068 38 Male 180.34 86.36 26.5 Black or African American Non-Hispanic/non- Latino31JUL2020 C4591001 1109 11091070 30 Male 170.18 73.27 25.2 White Hispanic/Latino 31JUL2020 C4591001 1109 11091071 31 Female 154.94 54.09 22.5 White Hispanic/Latino 31JUL2020 C4591001 1109 11091075 51 Male 182.88 75 22.4 White Non-Hispanic/non- Latino31JUL2020 C4591001 1109 11091077 33 Male 182.88 96.73 28.9 White Hispanic/Latino 01AUG2020 C4591001 1109 11091078 43 Male 187.96 122.73 34.7 White Non-Hispanic/non- Latino01AUG2020 C4591001 1109 11091080 55 Female 160.02 76.36 29.8 White Non-Hispanic/non- Latino01AUG2020 C4591001 1109 11091082 48 Female 167.64 54.82 19.5 White Hispanic/Latino 01AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 108 FDA-CBER-2021-5683-0032478 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1109 11091083 55 Male 182.88 92.27 27.5 White Non-Hispanic/non- Latino01AUG2020 C4591001 1109 11091086 49 Female 169.93 61.82 21.4 White Non-Hispanic/non- Latino01AUG2020 C4591001 1109 11091092 18 Male 180.34 62.27 19.1 White Non-Hispanic/non- Latino01AUG2020 C4591001 1109 11091098 26 Female 162.56 93 35.1 White Hispanic/Latino 01AUG2020 C4591001 1109 11091099 42 Male 182.88 127.27 38 White Non-Hispanic/non- Latino01AUG2020 C4591001 1109 11091100 30 Male 175.26 136.36 44.3 White Non-Hispanic/non- Latino01AUG2020 C4591001 1109 11091102 39 Male 162.56 79.55 30 White Not reported 01AUG2020 C4591001 1109 11091105 52 Male 177.8 102.27 32.3 White Non-Hispanic/non- Latino03AUG2020 C4591001 1109 11091106 29 Male 170.18 88.18 30.4 Black or African American Non-Hispanic/non- Latino03AUG2020 C4591001 1109 11091108 53 Male 177.8 131.82 41.6 White Non-Hispanic/non- Latino03AUG2020 C4591001 1109 11091109 37 Male 170.18 74.09 25.5 White Non-Hispanic/non- Latino03AUG2020 C4591001 1109 11091110 38 Male 187.96 102.27 28.9 White Non-Hispanic/non- Latino03AUG2020 C4591001 1109 11091112 34 Male 177.8 106.82 33.7 White Hispanic/Latino 03AUG2020 C4591001 1109 11091115 55 Male 186.69 94.55 27.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1109 11091117 55 Male 175.26 105 34.1 White Hispanic/Latino 03AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 109 FDA-CBER-2021-5683-0032479 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1109 11091122 50 Male 187.96 159.09 44.9 American Indian or Alaska Native Non-Hispanic/non- Latino03AUG2020 C4591001 1109 11091126 41 Male 177.8 120.45 38 White Non-Hispanic/non- Latino03AUG2020 C4591001 1109 11091127 55 Female 162.56 59.09 22.3 White Non-Hispanic/non- Latino03AUG2020 C4591001 1109 11091132 19 Female 160.02 95.09 37.1 White Non-Hispanic/non- Latino03AUG2020 C4591001 1109 11091134 44 Female 170.18 120.45 41.5 White Non-Hispanic/non- Latino03AUG2020 C4591001 1109 11091136 39 Male 182.88 90.91 27.1 White Non-Hispanic/non- Latino04AUG2020 C4591001 1109 11091145 55 Male 172.72 65.91 22 Asian Non-Hispanic/non- Latino04AUG2020 C4591001 1109 11091147 46 Female 157.48 79.55 32 White Non-Hispanic/non- Latino04AUG2020 C4591001 1109 11091148 29 Male 180.34 93.41 28.7 Black or African American Non-Hispanic/non- Latino04AUG2020 C4591001 1109 11091156 48 Female 162.56 56.82 21.5 American Indian or Alaska Native Non-Hispanic/non- Latino04AUG2020 C4591001 1109 11091158 55 Male 177.8 113.27 35.8 White Non-Hispanic/non- Latino04AUG2020 C4591001 1109 11091159 43 Female 162.56 56.82 21.5 Asian Non-Hispanic/non- Latino04AUG2020 C4591001 1109 11091160 41 Female 162.56 75 28.3 White Non-Hispanic/non- Latino04AUG2020 C4591001 1109 11091176 24 Male 182.88 95.45 28.5 White Non-Hispanic/non- Latino08AUG2020 C4591001 1109 11091178 45 Male 172.72 54.55 18.2 White Non-Hispanic/non- Latino08AUG2020 090177e196af7ce5\Final\Final On: 01-Apr-2021 14:10 (GMT) Page 110 FDA-CBER-2021-5683-0032480 16.2.4 Listing of Demographic Char acteristics – All Subjects ≥1 6 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm)Weight (kg) Body Mass Index (BMI) (kg/m2) Race Racial Designation Ethnicity Informed Consent Date (Screening) C4591001 1109 11091180 36 Male 175.26 95.45 31 White Non-Hispanic/non- Latino08AUG2020 C4591001 1109 11091183 50 Male 198.12 138.64 35.2 White Non-Hispanic/non- Latino08AUG2020 C4591001 1109 11091184 38 Male 182.88 98.18 29.3 White Non-Hispanic/non- Latino08AUG2020 C4591001 1109 11091185 52 Male 195.58 125 32.6 White Non-Hispanic/non- Latino10AUG2020 C4591001 1109 11091186 41 Female 165.1 148.18 54.2 Black or African American Non-Hispanic/non- Latino10AUG2020 C4591001 1109 11091187 37 Male 170.18 70.09 24.1 White Hispanic/Latino 10AUG2020 C4591001 1109 11091190 53 Male 170.18 136.36 47 Black or African American Hispanic/Latino 10AUG2020 C4591001 1109 11091197 34 Female 172.72 100 33.4 White Non-Hispanic/non- Latino10AUG2020 C4591001 1109 11091199 44 Male 182.88 88.64 26.4 White Non-Hispanic/non- Latino11AUG2020 C4591001 1109 11091204 27 Male 182.88 90.91 27.1 White Non-Hispanic/non- Latino11AUG2020 C4591001 1109 11091205 28 Female 177.8 68.18 21.5 White Non-Hispanic/non- Latino11AUG2020 C4591001 1109 11091211 42 Female 160.02 118.18 46.1 Black or African American Non-Hispanic/non- Latino13AUG2020 C4591001 1109 11091213 43 Female 175.26 88.64 28.8 White Hispanic/Latino 13AUG2020 C4591001 1109 11091214 55 Female 16 …[truncated]