125742 45 S211 M5 c4591001 interim ado demographics
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16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) 12-15 C4591001 1005 10051317 12 Female 145.54 51.18 24.1 White Non-Hispanic/non- Latino20OCT2020 C4591001 1005 10051328 14 Female 160.02 57.09 22.2 White Non-Hispanic/non- Latino20OCT2020 C4591001 1005 10051339 14 Female 161.29 54.64 21 White Non-Hispanic/non- Latino21OCT2020 C4591001 1005 10051410 13 Female 152.4 35.45 15.2 White Non-Hispanic/non- Latino09DEC2020 C4591001 1005 10051412# 14 Female 157.48 93.73 37.7 White Non-Hispanic/non- Latino14DEC2020 C4591001 1005 10051413# 15 Male 193.04 105.45 28.2 White Non-Hispanic/non- Latino14DEC2020 C4591001 1005 10051414 13 Female 170.18 76.09 26.2 White Non-Hispanic/non- Latino14DEC2020 C4591001 1005 10051415 15 Male 164.59 51.45 19 White Non-Hispanic/non- Latino14DEC2020 C4591001 1005 10051417 13 Female 157.48 48.64 19.6 White Non-Hispanic/non- Latino16DEC2020 C4591001 1005 10051418 15 Female 162.56 54.73 20.7 White Non-Hispanic/non- Latino16DEC2020 C4591001 1005 10051419 15 Female 162.56 53.91 20.4 White Non-Hispanic/non- Latino16DEC2020 C4591001 1005 10051420 12 Female 166.37 49.09 17.7 White Non-Hispanic/non- Latino16DEC2020 C4591001 1005 10051421 13 Male 174.24 54.18 17.8 Black or African American Non-Hispanic/non- Latino17DEC2020 C4591001 1005 10051422 12 Male 152.4 38.18 16.4 Black or African American Non-Hispanic/non- Latino17DEC2020 C4591001 1005 10051424 13 Male 156.21 38.09 15.6 White Non-Hispanic/non- Latino18DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 1 FDA-CBER-2022-5812-0223374 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1005 10051425 13 Female 168.15 64.45 22.7 White Non-Hispanic/non- Latino18DEC2020 C4591001 1005 10051427 14 Female 162.56 59.82 22.6 White Non-Hispanic/non- Latino21DEC2020 C4591001 1005 10051428 15 Female 170.18 67.68 23.3 White Non-Hispanic/non- Latino21DEC2020 C4591001 1005 10051429 14 Male 156.97 42.45 17.2 White Non-Hispanic/non- Latino21DEC2020 C4591001 1005 10051430 15 Male 185.42 71.73 20.8 White Non-Hispanic/non- Latino22DEC2020 C4591001 1005 10051431# 14 Male 180.34 98.18 30.1 White Non-Hispanic/non- Latino22DEC2020 C4591001 1005 10051436 15 Female 168.91 51.55 18 White Non-Hispanic/non- Latino22DEC2020 C4591001 1005 10051437 15 Female 160.02 66.09 25.8 White Non-Hispanic/non- Latino22DEC2020 C4591001 1005 10051438 13 Male 154.69 35.91 15 White Non-Hispanic/non- Latino22DEC2020 C4591001 1005 10051439 14 Male 180.34 74.09 22.7 White Non-Hispanic/non- Latino22DEC2020 C4591001 1005 10051440# 12 Male 164.59 71 26.2 White Non-Hispanic/non- Latino22DEC2020 C4591001 1005 10051441 15 Female 154.94 61.82 25.7 White Non-Hispanic/non- Latino22DEC2020 C4591001 1005 10051444# 15 Male 170.18 79.82 27.5 White Non-Hispanic/non- Latino22DEC2020 C4591001 1005 10051445 14 Female 175.26 60.82 19.8 White Non-Hispanic/non- Latino22DEC2020 C4591001 1005 10051447 14 Female 170.18 77.27 26.6 White Non-Hispanic/non- Latino11JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 2 FDA-CBER-2022-5812-0223375 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1005 10051448 12 Female 160.02 59.45 23.2 White Non-Hispanic/non- Latino11JAN2021 C4591001 1005 10051449 14 Male 178.31 82.82 26 White Hispanic/Latino 11JAN2021 C4591001 1005 10051450 14 Male 168.91 61.18 21.4 Asian Non-Hispanic/non- Latino11JAN2021 C4591001 1005 10051451 15 Female 153.67 41.55 17.6 White Non-Hispanic/non- Latino12JAN2021 C4591001 1006 10061183# 14 Male 166.37 97.73 35.2 Multiracial Hispanic/Latino 30NOV2020 C4591001 1006 10061184 15 Male 166.37 54.18 19.5 White Non-Hispanic/non- Latino30NOV2020 C4591001 1006 10061188 12 Female 152.4 45.18 19.4 Asian Non-Hispanic/non- Latino01DEC2020 C4591001 1006 10061189 15 Male 173.99 59.23 19.5 Asian Non-Hispanic/non- Latino01DEC2020 C4591001 1006 10061190 15 Male 171.45 75.45 25.6 White Non-Hispanic/non- Latino02DEC2020 C4591001 1006 10061191 15 Female 162.56 62.73 23.7 White Hispanic/Latino 02DEC2020 C4591001 1006 10061196 12 Male 167.64 57.59 20.4 White Hispanic/Latino 02DEC2020 C4591001 1006 10061200 15 Male 173.99 79.55 26.2 White Non-Hispanic/non- Latino03DEC2020 C4591001 1006 10061201# 12 Male 162.56 74.27 28 White Non-Hispanic/non- Latino03DEC2020 C4591001 1006 10061203 13 Female 161.29 50.09 19.2 White Non-Hispanic/non- Latino03DEC2020 C4591001 1006 10061206 12 Male 161.29 63.59 24.4 White Non-Hispanic/non- Latino04DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 3 FDA-CBER-2022-5812-0223376 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1006 10061207 14 Male 172.72 54.64 18.3 White Non-Hispanic/non- Latino04DEC2020 C4591001 1006 10061209 13 Male 170.69 57.73 19.8 White Non-Hispanic/non- Latino04DEC2020 C4591001 1006 10061212 14 Female 161.29 49.91 19.1 White Non-Hispanic/non- Latino04DEC2020 C4591001 1006 10061213 12 Male 166.37 52.82 19 White Non-Hispanic/non- Latino04DEC2020 C4591001 1006 10061214# 14 Male 175.26 90.27 29.3 Black or African American Hispanic/Latino 04DEC2020 C4591001 1006 10061219 14 Male 193.8 82.64 22 White Non-Hispanic/non- Latino07DEC2020 C4591001 1006 10061220 15 Male 176.53 70.73 22.6 White Non-Hispanic/non- Latino07DEC2020 C4591001 1006 10061221 15 Female 160.02 58.5 22.8 White Non-Hispanic/non- Latino07DEC2020 C4591001 1006 10061223 15 Male 152.4 37.09 15.9 White Non-Hispanic/non- Latino07DEC2020 C4591001 1006 10061224 14 Female 160.02 68.18 26.6 White Non-Hispanic/non- Latino07DEC2020 C4591001 1006 10061226 15 Female 161.29 49.64 19 White Non-Hispanic/non- Latino07DEC2020 C4591001 1006 10061227 15 Female 162.56 55.55 21 White Non-Hispanic/non- Latino07DEC2020 C4591001 1006 10061228 12 Female 161.29 46.73 17.9 White Non-Hispanic/non- Latino08DEC2020 C4591001 1006 10061229 15 Female 160.78 49.64 19.2 White Non-Hispanic/non- Latino08DEC2020 C4591001 1006 10061230 14 Female 166.37 60.77 21.9 Multiracial Non-Hispanic/non- Latino08DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 4 FDA-CBER-2022-5812-0223377 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1006 10061231 12 Female 151.77 52 22.5 White Non-Hispanic/non- Latino08DEC2020 C4591001 1006 10061232 13 Female 168.91 47.45 16.6 White Non-Hispanic/non- Latino08DEC2020 C4591001 1006 10061233 15 Male 173.99 46.64 15.4 White Non-Hispanic/non- Latino08DEC2020 C4591001 1006 10061234 13 Male 167.64 48.82 17.3 White Non-Hispanic/non- Latino09DEC2020 C4591001 1006 10061235 15 Male 182.88 60.18 18 White Non-Hispanic/non- Latino09DEC2020 C4591001 1006 10061236 15 Female 156.21 49.27 20.1 Asian Non-Hispanic/non- Latino09DEC2020 C4591001 1006 10061237 14 Male 170.18 66.95 23.1 White Non-Hispanic/non- Latino09DEC2020 C4591001 1006 10061239 14 Female 172.72 65.18 21.8 White Non-Hispanic/non- Latino09DEC2020 C4591001 1006 10061241 14 Female 159.51 48.09 18.9 White Non-Hispanic/non- Latino09DEC2020 C4591001 1006 10061242 15 Male 172.72 52.27 17.5 White Non-Hispanic/non- Latino09DEC2020 C4591001 1006 10061243 13 Female 183.13 69.18 20.6 White Non-Hispanic/non- Latino10DEC2020 C4591001 1006 10061244 15 Male 163.83 53.64 19.9 White Non-Hispanic/non- Latino10DEC2020 C4591001 1006 10061245 15 Male 162.56 49.36 18.6 White Non-Hispanic/non- Latino10DEC2020 C4591001 1006 10061247 13 Female 165.1 61.45 22.5 White Non-Hispanic/non- Latino10DEC2020 C4591001 1006 10061248 13 Male 166.37 51 18.4 White Non-Hispanic/non- Latino11DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 5 FDA-CBER-2022-5812-0223378 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1006 10061249# 15 Female 158.75 133.09 52.7 White Hispanic/Latino 11DEC2020 C4591001 1006 10061250# 13 Male 168.91 84.91 29.7 White Hispanic/Latino 11DEC2020 C4591001 1006 10061252 14 Male 156.21 38.09 15.6 White Non-Hispanic/non- Latino11DEC2020 C4591001 1006 10061253 14 Male 180.34 63.18 19.4 White Non-Hispanic/non- Latino11DEC2020 C4591001 1006 10061254# 14 Female 165.1 95.45 34.9 White Non-Hispanic/non- Latino11DEC2020 C4591001 1006 10061256 15 Female 163.83 70 26 White Non-Hispanic/non- Latino11DEC2020 C4591001 1006 10061257 15 Female 163.07 53.32 20 Asian Non-Hispanic/non- Latino11DEC2020 C4591001 1006 10061258 14 Male 183.39 67.64 20.1 Native Hawaiian or other Pacific Islande rNon-Hispanic/non- Latino14DEC2020 C4591001 1006 10061259 15 Female 163.83 45.45 16.9 White Non-Hispanic/non- Latino14DEC2020 C4591001 1006 10061260 12 Female 153.67 37.36 15.8 White Non-Hispanic/non- Latino14DEC2020 C4591001 1006 10061261 14 Male 160.02 43.45 16.9 White Non-Hispanic/non- Latino14DEC2020 C4591001 1006 10061262 15 Male 175.51 70.55 22.9 White Non-Hispanic/non- Latino14DEC2020 C4591001 1006 10061263 12 Female 147.32 37.55 17.3 White Non-Hispanic/non- Latino14DEC2020 C4591001 1006 10061264# 13 Male 176.53 82.36 26.4 White Hispanic/Latino 14DEC2020 C4591001 1006 10061265 13 Male 154.94 36.45 15.2 White Non-Hispanic/non- Latino15DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 6 FDA-CBER-2022-5812-0223379 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1006 10061266 15 Female 165.35 69 25.2 Multiracial Non-Hispanic/non- Latino15DEC2020 C4591001 1006 10061267 15 Female 165.61 61.68 22.4 Asian Non-Hispanic/non- Latino15DEC2020 C4591001 1006 10061269 14 Male 167.64 48.09 17.1 White Non-Hispanic/non- Latino15DEC2020 C4591001 1006 10061270 15 Female 167.64 59.82 21.2 White Non-Hispanic/non- Latino16DEC2020 C4591001 1006 10061271 14 Male 156.21 48.09 19.7 White Non-Hispanic/non- Latino16DEC2020 C4591001 1006 10061272 13 Female 172.72 67.27 22.5 Black or African American Non-Hispanic/non- Latino16DEC2020 C4591001 1006 10061273 13 Male 172.72 71.27 23.8 White Non-Hispanic/non- Latino16DEC2020 C4591001 1006 10061274 14 Female 173.23 44.91 14.9 White Non-Hispanic/non- Latino16DEC2020 C4591001 1006 10061276 15 Female 162.56 54.73 20.7 White Non-Hispanic/non- Latino17DEC2020 C4591001 1006 10061277 13 Female 172.09 71.86 24.2 White Non-Hispanic/non- Latino17DEC2020 C4591001 1006 10061278 13 Male 163.07 42 15.8 White Non-Hispanic/non- Latino17DEC2020 C4591001 1006 10061279# 13 Female 160.02 80.73 31.5 White Non-Hispanic/non- Latino17DEC2020 C4591001 1006 10061280# 15 Male 172.72 89.73 30 White Hispanic/Latino 17DEC2020 C4591001 1006 10061282 13 Male 171.45 54.09 18.4 White Non-Hispanic/non- Latino18DEC2020 C4591001 1006 10061283 15 Male 170.94 57 19.5 White Non-Hispanic/non- Latino18DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 7 FDA-CBER-2022-5812-0223380 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1006 10061284# 14 Male 182.88 98.27 29.3 White Non-Hispanic/non- Latino18DEC2020 C4591001 1006 10061285 14 Female 161.29 48.36 18.6 White Non-Hispanic/non- Latino21DEC2020 C4591001 1006 10061286 14 Male 180.34 53.82 16.5 White Non-Hispanic/non- Latino21DEC2020 C4591001 1006 10061287 13 Male 165.1 47 17.2 White Non-Hispanic/non- Latino21DEC2020 C4591001 1006 10061288 15 Female 167.64 64.36 22.9 White Non-Hispanic/non- Latino21DEC2020 C4591001 1006 10061289 13 Female 153.67 53.64 22.7 White Non-Hispanic/non- Latino22DEC2020 C4591001 1006 10061290 15 Female 151.13 50.55 22.1 White Non-Hispanic/non- Latino22DEC2020 C4591001 1006 10061291 13 Male 151.13 35.55 15.5 White Non-Hispanic/non- Latino22DEC2020 C4591001 1006 10061292 15 Female 168.91 52.27 18.3 White Non-Hispanic/non- Latino22DEC2020 C4591001 1006 10061293 15 Male 181.61 86.36 26.1 White Non-Hispanic/non- Latino22DEC2020 C4591001 1006 10061294 14 Female 166.37 71.91 25.9 White Non-Hispanic/non- Latino22DEC2020 C4591001 1006 10061295 12 Male 166.37 47.45 17.1 White Non-Hispanic/non- Latino24DEC2020 C4591001 1006 10061296 14 Male 173.99 51.82 17.1 White Hispanic/Latino 29DEC2020 C4591001 1006 10061297 12 Female 157.48 56.5 22.7 White Hispanic/Latino 29DEC2020 C4591001 1006 10061298# 13 Female 167.64 75.45 26.8 White Non-Hispanic/non- Latino29DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 8 FDA-CBER-2022-5812-0223381 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1006 10061299 14 Male 168.91 52.59 18.4 White Non-Hispanic/non- Latino31DEC2020 C4591001 1006 10061300 15 Male 170.18 52.45 18.1 White Non-Hispanic/non- Latino07JAN2021 C4591001 1007 10071409 13 Male 154 36.2 15.3 Asian Non-Hispanic/non- Latino22OCT2020 C4591001 1007 10071414 14 Male 166.5 46.4 16.7 White Non-Hispanic/non- Latino22OCT2020 C4591001 1007 10071415 12 Male 142 32 15.9 White Non-Hispanic/non- Latino22OCT2020 C4591001 1007 10071417 15 Male 191.8 100.2 27.2 White Non-Hispanic/non- Latino22OCT2020 C4591001 1007 10071428 12 Male 160 41.8 16.3 Asian Non-Hispanic/non- Latino22OCT2020 C4591001 1007 10071429 13 Female 159 47.7 18.9 White Non-Hispanic/non- Latino22OCT2020 C4591001 1007 10071467 15 Female 159 55.1 21.8 White Non-Hispanic/non- Latino30NOV2020 C4591001 1007 10071469 14 Male 126 39.6 24.9 White Non-Hispanic/non- Latino30NOV2020 C4591001 1007 10071471 14 Male 175 62.5 20.4 White Non-Hispanic/non- Latino30NOV2020 C4591001 1007 10071472 13 Female 159 50 19.8 White Non-Hispanic/non- Latino30NOV2020 C4591001 1007 10071475 15 Female 167 57.4 20.6 White Non-Hispanic/non- Latino30NOV2020 C4591001 1007 10071476 13 Female 159 54 21.4 White Non-Hispanic/non- Latino30NOV2020 C4591001 1007 10071478 14 Male 191 93.6 25.7 White Non-Hispanic/non- Latino30NOV2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 9 FDA-CBER-2022-5812-0223382 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1007 10071480# 14 Male 175.5 95.9 31.1 White Non-Hispanic/non- Latino30NOV2020 C4591001 1007 10071481 12 Female 162 47.6 18.1 White Non-Hispanic/non- Latino01DEC2020 C4591001 1007 10071482 13 Female 165.5 53 19.3 White Non-Hispanic/non- Latino01DEC2020 C4591001 1007 10071483 15 Female 169 50.8 17.8 White Non-Hispanic/non- Latino01DEC2020 C4591001 1007 10071484 13 Female 168.5 55.3 19.5 White Non-Hispanic/non- Latino01DEC2020 C4591001 1007 10071485 14 Female 163.5 59.6 22.3 White Non-Hispanic/non- Latino01DEC2020 C4591001 1007 10071488 14 Female 175 78.4 25.6 White Non-Hispanic/non- Latino01DEC2020 C4591001 1007 10071490 13 Male 175 57.4 18.7 White Hispanic/Latino 01DEC2020 C4591001 1007 10071492 13 Female 157 47.7 19.4 White Non-Hispanic/non- Latino01DEC2020 C4591001 1007 10071494 15 Male 189.5 79.1 22 White Non-Hispanic/non- Latino02DEC2020 C4591001 1007 10071495 15 Male 165 60.6 22.3 White Non-Hispanic/non- Latino02DEC2020 C4591001 1007 10071496 14 Female 167 46.2 16.6 Asian Non-Hispanic/non- Latino02DEC2020 C4591001 1007 10071497 12 Male 151 39 17.1 Asian Non-Hispanic/non- Latino02DEC2020 C4591001 1007 10071499 14 Male 170 50.9 17.6 White Non-Hispanic/non- Latino03DEC2020 C4591001 1007 10071500 15 Female 163.3 51.3 19.2 White Non-Hispanic/non- Latino03DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 10 FDA-CBER-2022-5812-0223383 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1007 10071504 15 Male 186 90.2 26.1 White Non-Hispanic/non- Latino07DEC2020 C4591001 1007 10071505 12 Female 153 53.8 23 White Non-Hispanic/non- Latino07DEC2020 C4591001 1007 10071506 15 Female 175 69.8 22.8 White Non-Hispanic/non- Latino07DEC2020 C4591001 1007 10071507 13 Male 177.5 59.7 18.9 Asian Non-Hispanic/non- Latino07DEC2020 C4591001 1007 10071508 14 Female 168 54.5 19.3 White Non-Hispanic/non- Latino07DEC2020 C4591001 1007 10071509 15 Female 162.5 71.5 27.1 White Non-Hispanic/non- Latino07DEC2020 C4591001 1007 10071511 15 Male 177 75.6 24.1 White Non-Hispanic/non- Latino07DEC2020 C4591001 1007 10071512 15 Female 169.5 59.7 20.8 White Non-Hispanic/non- Latino07DEC2020 C4591001 1007 10071514 12 Male 151 37.9 16.6 White Non-Hispanic/non- Latino07DEC2020 C4591001 1007 10071515 12 Male 170.5 61.7 21.2 White Non-Hispanic/non- Latino08DEC2020 C4591001 1007 10071516 15 Male 173 52.2 17.4 White Non-Hispanic/non- Latino08DEC2020 C4591001 1007 10071517 12 Male 148 38.1 17.4 White Non-Hispanic/non- Latino08DEC2020 C4591001 1007 10071518# 15 Male 176 95.8 30.9 White Hispanic/Latino 08DEC2020 C4591001 1007 10071519 15 Male 177.5 65.6 20.8 White Non-Hispanic/non- Latino08DEC2020 C4591001 1007 10071520 13 Male 179 63.3 19.8 White Non-Hispanic/non- Latino08DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 11 FDA-CBER-2022-5812-0223384 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1007 10071521 13 Male 171 61.1 20.9 White Non-Hispanic/non- Latino08DEC2020 C4591001 1007 10071522 15 Female 168 74.9 26.5 White Non-Hispanic/non- Latino08DEC2020 C4591001 1007 10071523 13 Female 148.5 40.3 18.3 White Non-Hispanic/non- Latino08DEC2020 C4591001 1007 10071524 15 Male 175 63.4 20.7 White Non-Hispanic/non- Latino08DEC2020 C4591001 1007 10071525 13 Male 168.5 70.4 24.8 White Non-Hispanic/non- Latino08DEC2020 C4591001 1007 10071526 14 Female 172 55 18.6 White Non-Hispanic/non- Latino08DEC2020 C4591001 1007 10071527 12 Male 168 46.7 16.5 White Non-Hispanic/non- Latino08DEC2020 C4591001 1007 10071528 14 Female 170 70 24.2 White Non-Hispanic/non- Latino09DEC2020 C4591001 1007 10071529 14 Female 155.4 45.9 19 Multiracial Non-Hispanic/non- Latino09DEC2020 C4591001 1007 10071530# 12 Female 160 64.9 25.4 White Non-Hispanic/non- Latino09DEC2020 C4591001 1007 10071531 14 Female 166.5 71.4 25.8 White Non-Hispanic/non- Latino09DEC2020 C4591001 1007 10071533# 14 Male 181.9 93.2 28.2 White Non-Hispanic/non- Latino09DEC2020 C4591001 1007 10071535 15 Male 181.9 73.9 22.3 White Non-Hispanic/non- Latino09DEC2020 C4591001 1007 10071536 13 Female 165 49.1 18 White Non-Hispanic/non- Latino09DEC2020 C4591001 1007 10071537 13 Male 175 77.7 25.4 White Non-Hispanic/non- Latino09DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 12 FDA-CBER-2022-5812-0223385 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1007 10071539 15 Male 164.5 47.8 17.7 White Non-Hispanic/non- Latino09DEC2020 C4591001 1007 10071540 13 Male 157 49.6 20.1 White Non-Hispanic/non- Latino09DEC2020 C4591001 1007 10071541 15 Male 172 62.6 21.2 White Non-Hispanic/non- Latino09DEC2020 C4591001 1007 10071542 13 Female 168 59.1 20.9 White Non-Hispanic/non- Latino09DEC2020 C4591001 1007 10071543 14 Male 162 57.3 21.8 White Non-Hispanic/non- Latino09DEC2020 C4591001 1007 10071544 12 Male 146 38 17.8 White Non-Hispanic/non- Latino09DEC2020 C4591001 1007 10071546 15 Male 184.4 82.3 24.2 White Non-Hispanic/non- Latino10DEC2020 C4591001 1007 10071547 14 Male 171.5 59.8 20.3 White Non-Hispanic/non- Latino10DEC2020 C4591001 1007 10071550 13 Female 163.5 40.4 15.1 White Non-Hispanic/non- Latino10DEC2020 C4591001 1007 10071551 13 Male 162 51.3 19.5 White Non-Hispanic/non- Latino10DEC2020 C4591001 1007 10071552 15 Female 167 58.7 21 White Non-Hispanic/non- Latino10DEC2020 C4591001 1007 10071554 14 Female 171 71.7 24.5 White Non-Hispanic/non- Latino10DEC2020 C4591001 1007 10071555 12 Male 157.5 42.5 17.1 White Non-Hispanic/non- Latino10DEC2020 C4591001 1007 10071557 15 Female 160 50.8 19.8 White Non-Hispanic/non- Latino14DEC2020 C4591001 1007 10071558 14 Female 165.5 61.9 22.6 White Non-Hispanic/non- Latino14DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 13 FDA-CBER-2022-5812-0223386 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1007 10071559 14 Female 170 62 21.5 White Non-Hispanic/non- Latino14DEC2020 C4591001 1007 10071560 12 Female 160 43 16.8 White Non-Hispanic/non- Latino14DEC2020 C4591001 1007 10071561 12 Female 153 43 18.4 White Non-Hispanic/non- Latino14DEC2020 C4591001 1007 10071562 12 Female 161 56.7 21.9 White Non-Hispanic/non- Latino14DEC2020 C4591001 1007 10071563# 12 Male 160 71.5 27.9 White Non-Hispanic/non- Latino14DEC2020 C4591001 1007 10071564 14 Female 161 53.8 20.8 White Non-Hispanic/non- Latino14DEC2020 C4591001 1007 10071565 14 Male 175 54 17.6 White Non-Hispanic/non- Latino14DEC2020 C4591001 1007 10071566 15 Male 178 74.6 23.5 White Non-Hispanic/non- Latino14DEC2020 C4591001 1007 10071567 14 Male 163 40.2 15.1 White Non-Hispanic/non- Latino15DEC2020 C4591001 1007 10071568 14 Male 170.2 63.6 22 White Non-Hispanic/non- Latino15DEC2020 C4591001 1007 10071569 12 Female 164.4 62.6 23.2 White Non-Hispanic/non- Latino15DEC2020 C4591001 1007 10071570# 15 Female 168.5 103.8 36.6 White Non-Hispanic/non- Latino15DEC2020 C4591001 1007 10071571 14 Female 160 49.3 19.3 White Non-Hispanic/non- Latino15DEC2020 C4591001 1007 10071572 12 Female 161.3 63.2 24.3 White Non-Hispanic/non- Latino15DEC2020 C4591001 1007 10071573 12 Male 162 49.2 18.7 White Non-Hispanic/non- Latino15DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 14 FDA-CBER-2022-5812-0223387 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1007 10071574 15 Male 181 67.4 20.6 White Non-Hispanic/non- Latino16DEC2020 C4591001 1007 10071575 15 Male 175 68.3 22.3 White Non-Hispanic/non- Latino16DEC2020 C4591001 1007 10071576 15 Female 169 53.8 18.8 White Non-Hispanic/non- Latino16DEC2020 C4591001 1007 10071577 15 Male 169 63 22.1 Multiracial Non-Hispanic/non- Latino16DEC2020 C4591001 1007 10071578 12 Male 146 40.1 18.8 Multiracial Non-Hispanic/non- Latino16DEC2020 C4591001 1007 10071579 12 Female 161 42 16.2 White Non-Hispanic/non- Latino16DEC2020 C4591001 1007 10071580 14 Female 163 55.3 20.8 White Non-Hispanic/non- Latino16DEC2020 C4591001 1007 10071581 15 Male 175 64.8 21.2 White Non-Hispanic/non- Latino17DEC2020 C4591001 1007 10071582 12 Male 165.7 58 21.1 White Non-Hispanic/non- Latino17DEC2020 C4591001 1007 10071583# 15 Male 173 87.4 29.2 White Non-Hispanic/non- Latino17DEC2020 C4591001 1007 10071584 15 Male 188 68.7 19.4 White Hispanic/Latino 17DEC2020 C4591001 1007 10071585# 12 Male 168 89.4 31.7 White Non-Hispanic/non- Latino17DEC2020 C4591001 1007 10071586 13 Male 165 69.1 25.4 White Non-Hispanic/non- Latino17DEC2020 C4591001 1007 10071587 14 Female 154.9 56.3 23.5 Asian Non-Hispanic/non- Latino17DEC2020 C4591001 1007 10071588 13 Male 147 40.4 18.7 White Non-Hispanic/non- Latino28DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 15 FDA-CBER-2022-5812-0223388 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1007 10071589 12 Male 145 31.7 15.1 White Non-Hispanic/non- Latino28DEC2020 C4591001 1007 10071590 14 Male 165 59.9 22 White Non-Hispanic/non- Latino28DEC2020 C4591001 1007 10071591 13 Male 161 50.1 19.3 White Non-Hispanic/non- Latino28DEC2020 C4591001 1007 10071592 13 Male 155 40 16.6 White Non-Hispanic/non- Latino28DEC2020 C4591001 1007 10071593 15 Male 201.7 100 24.6 White Non-Hispanic/non- Latino28DEC2020 C4591001 1007 10071594 14 Female 174 55.7 18.4 White Non-Hispanic/non- Latino28DEC2020 C4591001 1007 10071595 13 Female 162 49.4 18.8 White Non-Hispanic/non- Latino28DEC2020 C4591001 1007 10071596 13 Male 160 36.9 14.4 White Non-Hispanic/non- Latino28DEC2020 C4591001 1007 10071597 14 Female 159 37.2 14.7 White Non-Hispanic/non- Latino28DEC2020 C4591001 1007 10071599 14 Male 166 42.5 15.4 White Non-Hispanic/non- Latino28DEC2020 C4591001 1007 10071600 12 Female 150 39.2 17.4 White Non-Hispanic/non- Latino28DEC2020 C4591001 1007 10071601 15 Male 176.5 65.2 20.9 Asian Non-Hispanic/non- Latino28DEC2020 C4591001 1007 10071602 14 Male 165 47.1 17.3 White Non-Hispanic/non- Latino28DEC2020 C4591001 1007 10071603 13 Male 164 56.3 20.9 White Non-Hispanic/non- Latino29DEC2020 C4591001 1007 10071604 15 Female 172 77.1 26.1 White Non-Hispanic/non- Latino29DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 16 FDA-CBER-2022-5812-0223389 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1007 10071605 12 Male 154 38.8 16.4 White Non-Hispanic/non- Latino29DEC2020 C4591001 1007 10071606 13 Female 151 45.2 19.8 White Non-Hispanic/non- Latino29DEC2020 C4591001 1007 10071607 14 Female 163 67.4 25.4 White Non-Hispanic/non- Latino29DEC2020 C4591001 1007 10071608 12 Male 149 36.4 16.4 White Non-Hispanic/non- Latino29DEC2020 C4591001 1007 10071609 12 Male 162.5 56.6 21.4 White Non-Hispanic/non- Latino29DEC2020 C4591001 1007 10071610# 15 Female 161 87.8 33.9 American Indian or Alaska Native Hispanic/Latino 29DEC2020 C4591001 1007 10071612 14 Male 159 47.9 18.9 White Non-Hispanic/non- Latino29DEC2020 C4591001 1007 10071613 13 Male 166.1 51.2 18.6 White Non-Hispanic/non- Latino29DEC2020 C4591001 1007 10071614 14 Male 170 56.3 19.5 White Non-Hispanic/non- Latino29DEC2020 C4591001 1007 10071615 12 Male 155 45.9 19.1 White Non-Hispanic/non- Latino29DEC2020 C4591001 1007 10071616 15 Male 170.5 66.5 22.9 White Non-Hispanic/non- Latino29DEC2020 C4591001 1007 10071617 15 Female 167 62.3 22.3 White Non-Hispanic/non- Latino29DEC2020 C4591001 1007 10071618 13 Male 165 60.4 22.2 White Non-Hispanic/non- Latino29DEC2020 C4591001 1007 10071619 12 Male 155 39.5 16.4 White Non-Hispanic/non- Latino30DEC2020 C4591001 1007 10071620 12 Female 155.5 57.1 23.6 White Hispanic/Latino 30DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 17 FDA-CBER-2022-5812-0223390 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1007 10071621 14 Male 149 39.5 17.8 White Hispanic/Latino 30DEC2020 C4591001 1007 10071622 15 Male 162 59 22.5 White Hispanic/Latino 30DEC2020 C4591001 1007 10071623 13 Male 163 45 16.9 White Non-Hispanic/non- Latino30DEC2020 C4591001 1007 10071624 13 Male 170 55.5 19.2 White Non-Hispanic/non- Latino30DEC2020 C4591001 1007 10071625 13 Female 167 48.3 17.3 White Non-Hispanic/non- Latino30DEC2020 C4591001 1007 10071626 14 Male 156.5 43 17.6 White Non-Hispanic/non- Latino30DEC2020 C4591001 1007 10071627 14 Male 182 74.6 22.5 White Non-Hispanic/non- Latino30DEC2020 C4591001 1007 10071628 14 Male 183 55.7 16.6 White Non-Hispanic/non- Latino30DEC2020 C4591001 1007 10071629 15 Female 156 61.8 25.4 Asian Non-Hispanic/non- Latino30DEC2020 C4591001 1007 10071630 13 Male 153 51.9 22.2 Asian Non-Hispanic/non- Latino30DEC2020 C4591001 1007 10071631 12 Male 166 57.4 20.8 White Non-Hispanic/non- Latino30DEC2020 C4591001 1007 10071632 13 Female 177 58.8 18.8 White Hispanic/Latino 30DEC2020 C4591001 1007 10071633 12 Male 156 47.3 19.4 White Non-Hispanic/non- Latino30DEC2020 C4591001 1007 10071634 14 Male 174 55.8 18.4 White Non-Hispanic/non- Latino04JAN2021 C4591001 1007 10071635 13 Male 165 50.7 18.6 White Non-Hispanic/non- Latino04JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 18 FDA-CBER-2022-5812-0223391 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1007 10071636# 12 Female 162 71.6 27.3 White Non-Hispanic/non- Latino04JAN2021 C4591001 1007 10071638 13 Female 166.5 65.9 23.8 White Non-Hispanic/non- Latino04JAN2021 C4591001 1007 10071639 13 Male 176 70.8 22.9 White Non-Hispanic/non- Latino04JAN2021 C4591001 1007 10071640 14 Female 162 48.7 18.6 White Non-Hispanic/non- Latino04JAN2021 C4591001 1007 10071641 13 Female 168 53.4 18.9 White Non-Hispanic/non- Latino04JAN2021 C4591001 1007 10071642 15 Male 170 45 15.6 White Non-Hispanic/non- Latino04JAN2021 C4591001 1007 10071643 12 Male 148 38.6 17.6 White Non-Hispanic/non- Latino04JAN2021 C4591001 1007 10071644 13 Male 160 35 13.7 White Non-Hispanic/non- Latino04JAN2021 C4591001 1007 10071645 14 Male 181 70.7 21.6 White Non-Hispanic/non- Latino04JAN2021 C4591001 1007 10071646 12 Male 147 31.8 14.7 White Non-Hispanic/non- Latino04JAN2021 C4591001 1007 10071647 12 Male 162.5 62.4 23.6 White Non-Hispanic/non- Latino04JAN2021 C4591001 1007 10071648 15 Male 176.5 60.5 19.4 Asian Non-Hispanic/non- Latino05JAN2021 C4591001 1007 10071649 14 Female 184 66.8 19.7 White Non-Hispanic/non- Latino05JAN2021 C4591001 1007 10071650# 13 Male 159.5 77.2 30.3 White Non-Hispanic/non- Latino05JAN2021 C4591001 1007 10071651 12 Male 160 44.6 17.4 White Non-Hispanic/non- Latino05JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 19 FDA-CBER-2022-5812-0223392 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1007 10071652 12 Female 164 55 20.4 White Non-Hispanic/non- Latino05JAN2021 C4591001 1007 10071653# 14 Male 174 82.1 27.1 White Non-Hispanic/non- Latino05JAN2021 C4591001 1007 10071654 12 Female 150.2 39.8 17.6 White Non-Hispanic/non- Latino05JAN2021 C4591001 1007 10071655 14 Male 167 45.4 16.3 White Non-Hispanic/non- Latino06JAN2021 C4591001 1007 10071656 14 Female 157.5 51.4 20.7 White Non-Hispanic/non- Latino06JAN2021 C4591001 1007 10071658 13 Female 164 68.4 25.4 White Non-Hispanic/non- Latino06JAN2021 C4591001 1007 10071659 15 Female 153 48.8 20.8 White Non-Hispanic/non- Latino06JAN2021 C4591001 1007 10071660 12 Male 150 33.7 15 White Non-Hispanic/non- Latino06JAN2021 C4591001 1007 10071661 13 Female 174 63.9 21.1 White Non-Hispanic/non- Latino07JAN2021 C4591001 1007 10071662 15 Female 175.5 63.6 20.6 White Non-Hispanic/non- Latino07JAN2021 C4591001 1008 10081751# 13 Female 157.48 68.45 27.5 White Non-Hispanic/non- Latino01DEC2020 C4591001 1008 10081752 15 Male 167.64 56.45 20 Asian Non-Hispanic/non- Latino01DEC2020 C4591001 1008 10081753 14 Male 168.91 55 19.2 Asian Non-Hispanic/non- Latino01DEC2020 C4591001 1008 10081754 12 Male 163.83 41.91 15.6 White Non-Hispanic/non- Latino02DEC2020 C4591001 1008 10081755 15 Female 167.64 53.82 19.1 White Non-Hispanic/non- Latino02DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 20 FDA-CBER-2022-5812-0223393 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1008 10081756 15 Female 162.56 47.18 17.8 White Non-Hispanic/non- Latino02DEC2020 C4591001 1008 10081757 12 Male 165.1 47.45 17.4 White Non-Hispanic/non- Latino02DEC2020 C4591001 1008 10081758 15 Female 160.02 70.82 27.6 White Non-Hispanic/non- Latino02DEC2020 C4591001 1008 10081760 13 Female 166.37 62.64 22.6 White Non-Hispanic/non- Latino07DEC2020 C4591001 1008 10081761# 15 Female 165.1 91.36 33.4 White Non-Hispanic/non- Latino07DEC2020 C4591001 1008 10081763# 14 Male 175.26 93.45 30.4 White Non-Hispanic/non- Latino07DEC2020 C4591001 1008 10081764 13 Female 160.02 64.64 25.2 White Non-Hispanic/non- Latino07DEC2020 C4591001 1008 10081767 15 Male 176.53 55.82 17.9 White Non-Hispanic/non- Latino08DEC2020 C4591001 1008 10081768 14 Female 171.45 56.82 19.3 White Non-Hispanic/non- Latino08DEC2020 C4591001 1008 10081769 15 Male 174.63 50.73 16.6 White Non-Hispanic/non- Latino08DEC2020 C4591001 1008 10081770 14 Female 175.26 59.55 19.3 White Non-Hispanic/non- Latino09DEC2020 C4591001 1008 10081771 12 Female 161.29 60.36 23.2 White Non-Hispanic/non- Latino09DEC2020 C4591001 1008 10081773 13 Male 177.8 61.27 19.3 White Non-Hispanic/non- Latino09DEC2020 C4591001 1008 10081774 12 Female 167.64 58 20.6 White Non-Hispanic/non- Latino09DEC2020 C4591001 1008 10081775 14 Male 165.1 49.82 18.2 White Non-Hispanic/non- Latino09DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 21 FDA-CBER-2022-5812-0223394 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1008 10081777 15 Female 170.18 47 16.2 White Non-Hispanic/non- Latino10DEC2020 C4591001 1008 10081780 15 Female 162.56 61.91 23.4 White Non-Hispanic/non- Latino10DEC2020 C4591001 1008 10081781 13 Female 149.86 55 24.4 White Non-Hispanic/non- Latino10DEC2020 C4591001 1008 10081785 13 Female 163.83 65.55 24.4 Asian Non-Hispanic/non- Latino11DEC2020 C4591001 1008 10081788 13 Female 165.1 50.36 18.4 White Non-Hispanic/non- Latino14DEC2020 C4591001 1008 10081789 15 Male 180.34 64.91 19.9 White Non-Hispanic/non- Latino14DEC2020 C4591001 1008 10081790 12 Female 161.29 62.45 24 White Non-Hispanic/non- Latino14DEC2020 C4591001 1008 10081791 12 Male 167.01 50.36 18 White Non-Hispanic/non- Latino14DEC2020 C4591001 1008 10081792 13 Female 175.26 57.45 18.7 White Non-Hispanic/non- Latino14DEC2020 C4591001 1008 10081793 14 Male 189.87 70.45 19.5 White Non-Hispanic/non- Latino14DEC2020 C4591001 1008 10081794 12 Female 154.94 39.82 16.6 Asian Non-Hispanic/non- Latino14DEC2020 C4591001 1008 10081795 14 Male 172.72 57.55 19.2 White Non-Hispanic/non- Latino15DEC2020 C4591001 1008 10081796 15 Female 164.47 54.09 20 White Non-Hispanic/non- Latino15DEC2020 C4591001 1008 10081797 14 Female 154.31 60.91 25.5 American Indian or Alaska Native Hispanic/Latino 15DEC2020 C4591001 1008 10081798 13 Female 149.86 41.18 18.3 White Non-Hispanic/non- Latino15DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 22 FDA-CBER-2022-5812-0223395 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1008 10081799 13 Female 161.93 62.91 23.9 White Non-Hispanic/non- Latino15DEC2020 C4591001 1008 10081800 14 Female 167.64 47.91 17 White Non-Hispanic/non- Latino16DEC2020 C4591001 1008 10081801 15 Female 172.72 70.45 23.6 White Non-Hispanic/non- Latino17DEC2020 C4591001 1008 10081802 13 Male 156.85 41 16.6 White Non-Hispanic/non- Latino17DEC2020 C4591001 1008 10081803# 15 Male 194.31 146.64 38.8 Black or African American Non-Hispanic/non- Latino17DEC2020 C4591001 1008 10081804 14 Female 157.48 51.36 20.7 Asian Non-Hispanic/non- Latino17DEC2020 C4591001 1008 10081805 12 Female 164.47 63.73 23.5 Asian Non-Hispanic/non- Latino17DEC2020 C4591001 1008 10081806 14 Female 173.99 56.45 18.6 White Non-Hispanic/non- Latino17DEC2020 C4591001 1008 10081807# 12 Female 172.72 80.55 26.9 White Non-Hispanic/non- Latino18DEC2020 C4591001 1008 10081808 13 Male 167.01 48.82 17.5 Asian Non-Hispanic/non- Latino18DEC2020 C4591001 1008 10081809 13 Female 167.64 54.73 19.4 Asian Non-Hispanic/non- Latino18DEC2020 C4591001 1008 10081810 13 Female 162.56 63.27 23.9 White Hispanic/Latino 18DEC2020 C4591001 1008 10081811 15 Female 154.94 62.82 26.1 White Hispanic/Latino 18DEC2020 C4591001 1008 10081812 14 Male 169.55 63.64 22.1 White Non-Hispanic/non- Latino18DEC2020 C4591001 1008 10081813 12 Male 161.29 54.91 21.1 White Non-Hispanic/non- Latino18DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 23 FDA-CBER-2022-5812-0223396 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1008 10081814 13 Female 151.13 47.27 20.7 White Non-Hispanic/non- Latino18DEC2020 C4591001 1008 10081815 12 Female 167.64 59.64 21.2 Black or African American Non-Hispanic/non- Latino18DEC2020 C4591001 1008 10081816 13 Female 165.74 61 22.2 Black or African American Non-Hispanic/non- Latino18DEC2020 C4591001 1008 10081817 13 Female 149.23 47.09 21.1 Asian Non-Hispanic/non- Latino18DEC2020 C4591001 1008 10081818 15 Male 165.1 48.55 17.8 White Non-Hispanic/non- Latino18DEC2020 C4591001 1008 10081819 12 Male 161.29 47.27 18.1 White Non-Hispanic/non- Latino21DEC2020 C4591001 1008 10081820 14 Female 173.36 58.82 19.5 White Non-Hispanic/non- Latino21DEC2020 C4591001 1008 10081821 13 Male 157.48 41.73 16.8 White Non-Hispanic/non- Latino21DEC2020 C4591001 1008 10081822 13 Female 173.99 56 18.5 White Non-Hispanic/non- Latino21DEC2020 C4591001 1008 10081823 14 Male 165.1 51.73 18.9 White Non-Hispanic/non- Latino21DEC2020 C4591001 1008 10081824 12 Male 151.77 32.36 14 White Non-Hispanic/non- Latino21DEC2020 C4591001 1008 10081825 12 Female 151.77 40 17.3 White Non-Hispanic/non- Latino21DEC2020 C4591001 1008 10081826 14 Male 170.82 58.73 20.1 White Non-Hispanic/non- Latino21DEC2020 C4591001 1008 10081827 15 Female 180.34 55.91 17.2 White Non-Hispanic/non- Latino21DEC2020 C4591001 1008 10081828 14 Female 168.91 67.91 23.7 White Non-Hispanic/non- Latino21DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 24 FDA-CBER-2022-5812-0223397 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1008 10081829 13 Male 177.17 49.73 15.8 Asian Non-Hispanic/non- Latino22DEC2020 C4591001 1008 10081830 13 Male 168.91 49 17.1 White Non-Hispanic/non- Latino22DEC2020 C4591001 1008 10081831 15 Male 167.64 70.91 25.2 White Non-Hispanic/non- Latino22DEC2020 C4591001 1008 10081832# 15 Female 162.56 114.27 43.1 White Non-Hispanic/non- Latino22DEC2020 C4591001 1008 10081833 13 Male 157.48 60 24.1 White Non-Hispanic/non- Latino22DEC2020 C4591001 1008 10081834 13 Male 156.85 47.73 19.4 White Non-Hispanic/non- Latino22DEC2020 C4591001 1008 10081835 14 Male 161.93 49.27 18.8 Asian Non-Hispanic/non- Latino22DEC2020 C4591001 1008 10081836 14 Female 169.55 65.75 22.8 White Non-Hispanic/non- Latino22DEC2020 C4591001 1008 10081837 12 Male 147.32 40.82 18.8 White Non-Hispanic/non- Latino22DEC2020 C4591001 1008 10081838 15 Male 152.4 59 25.3 White Non-Hispanic/non- Latino22DEC2020 C4591001 1008 10081839 15 Female 164.47 64.09 23.6 White Non-Hispanic/non- Latino22DEC2020 C4591001 1008 10081840 15 Female 166.37 59.09 21.3 White Non-Hispanic/non- Latino23DEC2020 C4591001 1008 10081841 14 Male 176.53 76.18 24.4 White Non-Hispanic/non- Latino23DEC2020 C4591001 1008 10081842 12 Female 152.4 40.09 17.2 White Non-Hispanic/non- Latino23DEC2020 C4591001 1008 10081843 15 Male 185.42 73.64 21.4 White Non-Hispanic/non- Latino23DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 25 FDA-CBER-2022-5812-0223398 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1008 10081844 12 Male 168.91 59.55 20.8 White Non-Hispanic/non- Latino23DEC2020 C4591001 1008 10081845 13 Female 160.02 50.91 19.8 White Non-Hispanic/non- Latino23DEC2020 C4591001 1008 10081846 15 Female 161.29 50.18 19.2 White Non-Hispanic/non- Latino23DEC2020 C4591001 1008 10081847# 14 Female 161.93 91.09 34.7 White Non-Hispanic/non- Latino23DEC2020 C4591001 1008 10081848 13 Male 158.75 40.91 16.2 White Non-Hispanic/non- Latino23DEC2020 C4591001 1008 10081849 12 Male 162.56 47 17.7 White Non-Hispanic/non- Latino23DEC2020 C4591001 1008 10081850 15 Female 153.67 48.18 20.4 White Non-Hispanic/non- Latino23DEC2020 C4591001 1008 10081851 13 Female 165.1 53.82 19.7 White Non-Hispanic/non- Latino23DEC2020 C4591001 1008 10081852# 15 Male 193.04 100.73 27 White Non-Hispanic/non- Latino23DEC2020 C4591001 1008 10081853 14 Female 168.28 57.45 20.2 White Non-Hispanic/non- Latino28DEC2020 C4591001 1008 10081854 15 Male 164.47 42.73 15.8 Asian Non-Hispanic/non- Latino28DEC2020 C4591001 1008 10081855 14 Male 164.47 53.18 19.6 Asian Non-Hispanic/non- Latino28DEC2020 C4591001 1008 10081856 14 Female 157.48 53.55 21.5 White Non-Hispanic/non- Latino28DEC2020 C4591001 1008 10081857 13 Female 156.21 45.09 18.4 White Non-Hispanic/non- Latino28DEC2020 C4591001 1008 10081858 15 Male 170.18 64.36 22.2 White Non-Hispanic/non- Latino28DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 26 FDA-CBER-2022-5812-0223399 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1008 10081859 15 Female 168.91 68.18 23.8 White Non-Hispanic/non- Latino28DEC2020 C4591001 1008 10081860 14 Male 168.28 62 21.8 White Non-Hispanic/non- Latino28DEC2020 C4591001 1008 10081861 14 Male 167.64 52.82 18.8 White Non-Hispanic/non- Latino29DEC2020 C4591001 1008 10081862 12 Female 168.28 54.09 19.1 White Non-Hispanic/non- Latino29DEC2020 C4591001 1008 10081863 13 Female 160.02 42.82 16.7 Asian Non-Hispanic/non- Latino29DEC2020 C4591001 1008 10081864 12 Female 148.59 34.73 15.7 Asian Non-Hispanic/non- Latino29DEC2020 C4591001 1008 10081865 13 Female 163.2 55.73 20.9 White Non-Hispanic/non- Latino29DEC2020 C4591001 1008 10081866 13 Male 156.21 51.55 21.1 White Hispanic/Latino 29DEC2020 C4591001 1008 10081867 13 Female 160.02 50.64 19.7 White Hispanic/Latino 29DEC2020 C4591001 1008 10081868 15 Female 165.1 61.91 22.7 White Non-Hispanic/non- Latino29DEC2020 C4591001 1008 10081869 14 Female 166.37 68.27 24.6 White Non-Hispanic/non- Latino29DEC2020 C4591001 1008 10081870 14 Male 157.48 58 23.3 White Non-Hispanic/non- Latino29DEC2020 C4591001 1008 10081871 14 Female 180.34 77.64 23.8 White Non-Hispanic/non- Latino30DEC2020 C4591001 1008 10081872 15 Male 173.99 50.55 16.7 White Non-Hispanic/non- Latino30DEC2020 C4591001 1008 10081873 13 Female 157.48 63.36 25.5 Black or African American Hispanic/Latino 30DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 27 FDA-CBER-2022-5812-0223400 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1008 10081874# 12 Male 165.1 78 28.6 White Hispanic/Latino 30DEC2020 C4591001 1008 10081875 15 Female 170.18 59.36 20.5 White Hispanic/Latino 30DEC2020 C4591001 1008 10081876 12 Male 154.31 36.64 15.4 White Non-Hispanic/non- Latino30DEC2020 C4591001 1008 10081877 14 Male 179.07 63 19.6 White Non-Hispanic/non- Latino30DEC2020 C4591001 1008 10081878 15 Female 168.28 62.73 22.1 White Non-Hispanic/non- Latino30DEC2020 C4591001 1008 10081879# 14 Male 161.93 76.18 29 White Non-Hispanic/non- Latino30DEC2020 C4591001 1008 10081880 14 Female 163.83 48.73 18.1 White Non-Hispanic/non- Latino30DEC2020 C4591001 1008 10081881 12 Female 167.64 49.55 17.6 White Non-Hispanic/non- Latino30DEC2020 C4591001 1008 10081882 15 Male 190.5 74.36 20.4 White Non-Hispanic/non- Latino31DEC2020 C4591001 1008 10081883 15 Female 172.09 68.45 23.1 White Non-Hispanic/non- Latino31DEC2020 C4591001 1008 10081884# 15 Female 161.29 106.41 40.8 White Non-Hispanic/non- Latino31DEC2020 C4591001 1008 10081885 14 Male 149.86 36.55 16.2 White Hispanic/Latino 31DEC2020 C4591001 1008 10081886 12 Female 144.78 29 13.8 White Hispanic/Latino 31DEC2020 C4591001 1008 10081887 12 Female 165.1 43.91 16.1 White Non-Hispanic/non- Latino04JAN2021 C4591001 1008 10081888 14 Male 174.63 59.91 19.6 White Non-Hispanic/non- Latino04JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 28 FDA-CBER-2022-5812-0223401 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1008 10081889 14 Female 181.61 78.36 23.7 White Non-Hispanic/non- Latino04JAN2021 C4591001 1008 10081890# 13 Male 182.88 90.91 27.1 White Non-Hispanic/non- Latino04JAN2021 C4591001 1008 10081891 14 Male 165.74 56.27 20.4 White Non-Hispanic/non- Latino04JAN2021 C4591001 1008 10081892 14 Male 163.2 70.45 26.4 American Indian or Alaska Native Hispanic/Latino 04JAN2021 C4591001 1008 10081893 14 Female 160.02 66.18 25.8 White Non-Hispanic/non- Latino04JAN2021 C4591001 1008 10081894 13 Female 172.72 56.27 18.8 White Non-Hispanic/non- Latino04JAN2021 C4591001 1008 10081895 14 Female 157.48 40.91 16.5 White Non-Hispanic/non- Latino04JAN2021 C4591001 1008 10081896 15 Male 188.6 84.91 23.8 White Non-Hispanic/non- Latino04JAN2021 C4591001 1008 10081897 13 Female 160.02 44.45 17.3 White Non-Hispanic/non- Latino05JAN2021 C4591001 1008 10081898 12 Female 160.02 56.09 21.9 White Non-Hispanic/non- Latino05JAN2021 C4591001 1008 10081899 15 Female 167.64 68.36 24.3 White Non-Hispanic/non- Latino05JAN2021 C4591001 1008 10081900 13 Female 169.55 72.18 25.1 White Non-Hispanic/non- Latino05JAN2021 C4591001 1008 10081901# 15 Male 178.44 90.45 28.3 White Non-Hispanic/non- Latino05JAN2021 C4591001 1008 10081902 14 Male 177.8 67.45 21.3 White Non-Hispanic/non- Latino05JAN2021 C4591001 1008 10081903 12 Male 147.32 38.64 17.8 White Non-Hispanic/non- Latino05JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 29 FDA-CBER-2022-5812-0223402 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1008 10081904# 12 Male 168.28 82 28.9 White Non-Hispanic/non- Latino05JAN2021 C4591001 1008 10081905 15 Female 180.98 59.45 18.1 White Non-Hispanic/non- Latino06JAN2021 C4591001 1008 10081906 14 Female 158.75 58.64 23.2 Asian Non-Hispanic/non- Latino06JAN2021 C4591001 1008 10081907 14 Female 157.48 59.09 23.8 White Non-Hispanic/non- Latino06JAN2021 C4591001 1008 10081908 12 Female 167.64 53.45 19 White Non-Hispanic/non- Latino06JAN2021 C4591001 1008 10081909 14 Male 170.18 54.18 18.7 Asian Non-Hispanic/non- Latino06JAN2021 C4591001 1008 10081910 14 Male 171.45 54.91 18.6 White Non-Hispanic/non- Latino06JAN2021 C4591001 1008 10081911 14 Male 154.94 47.73 19.8 White Non-Hispanic/non- Latino06JAN2021 C4591001 1008 10081912 12 Male 152.4 57.09 24.5 White Non-Hispanic/non- Latino06JAN2021 C4591001 1008 10081913 13 Male 171.45 54.45 18.5 White Non-Hispanic/non- Latino06JAN2021 C4591001 1008 10081914# 14 Male 176.53 94.45 30.2 White Non-Hispanic/non- Latino06JAN2021 C4591001 1008 10081915 13 Female 149.86 57.64 25.6 White Non-Hispanic/non- Latino07JAN2021 C4591001 1008 10081916 15 Male 180.34 85.45 26.2 White Non-Hispanic/non- Latino07JAN2021 C4591001 1008 10081917 13 Male 174.63 71.27 23.3 White Non-Hispanic/non- Latino07JAN2021 C4591001 1008 10081918 12 Female 147.32 39.36 18.1 White Non-Hispanic/non- Latino07JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 30 FDA-CBER-2022-5812-0223403 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1008 10081919 14 Female 160.66 52.82 20.4 White Non-Hispanic/non- Latino07JAN2021 C4591001 1008 10081920 13 Female 166.37 59.36 21.4 White Non-Hispanic/non- Latino07JAN2021 C4591001 1008 10081921 15 Male 186.69 64.82 18.6 White Non-Hispanic/non- Latino07JAN2021 C4591001 1008 10081922 12 Male 151.13 46 20.1 White Non-Hispanic/non- Latino08JAN2021 C4591001 1008 10081923 12 Female 162.56 42.09 15.9 White Non-Hispanic/non- Latino08JAN2021 C4591001 1008 10081924 12 Female 160.02 41.27 16.1 White Non-Hispanic/non- Latino08JAN2021 C4591001 1008 10081925 13 Female 162.56 55.91 21.1 Black or African American Non-Hispanic/non- Latino08JAN2021 C4591001 1008 10081926 14 Female 162.56 47.27 17.8 Asian Non-Hispanic/non- Latino08JAN2021 C4591001 1008 10081927 14 Female 161.93 44.09 16.8 Asian Non-Hispanic/non- Latino08JAN2021 C4591001 1008 10081928# 13 Female 163.83 74.09 27.5 White Non-Hispanic/non- Latino08JAN2021 C4591001 1008 10081929 12 Female 151.13 41.55 18.1 White Non-Hispanic/non- Latino08JAN2021 C4591001 1008 10081930 12 Female 160.02 42.09 16.4 White Non-Hispanic/non- Latino11JAN2021 C4591001 1008 10081931 12 Male 157.48 55.5 22.3 Asian Non-Hispanic/non- Latino11JAN2021 C4591001 1008 10081932 14 Female 157.48 52.09 21 Asian Non-Hispanic/non- Latino11JAN2021 C4591001 1008 10081933 12 Male 165.1 49.36 18.1 White Non-Hispanic/non- Latino11JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 31 FDA-CBER-2022-5812-0223404 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1008 10081934 13 Female 145.42 36.64 17.3 White Non-Hispanic/non- Latino11JAN2021 C4591001 1008 10081935 15 Male 167.64 72.73 25.8 White Non-Hispanic/non- Latino11JAN2021 C4591001 1008 10081936 14 Male 165.1 54.09 19.8 White Non-Hispanic/non- Latino11JAN2021 C4591001 1008 10081937 13 Female 161.29 51.73 19.8 Asian Non-Hispanic/non- Latino11JAN2021 C4591001 1008 10081938 15 Female 171.45 69.18 23.5 White Non-Hispanic/non- Latino11JAN2021 C4591001 1008 10081940 14 Male 172.09 70.73 23.8 White Non-Hispanic/non- Latino12JAN2021 C4591001 1008 10081941 12 Female 155.58 41 16.9 Asian Non-Hispanic/non- Latino12JAN2021 C4591001 1008 10081942 15 Male 178.44 70.09 22 Asian Non-Hispanic/non- Latino12JAN2021 C4591001 1008 10081943 15 Male 180.34 63.45 19.5 White Non-Hispanic/non- Latino12JAN2021 C4591001 1009 10091204 13 Male 171.45 51.18 17.4 White Non-Hispanic/non- Latino15OCT2020 C4591001 1009 10091205 15 Male 160.02 52.55 20.5 White Non-Hispanic/non- Latino15OCT2020 C4591001 1009 10091208 15 Male 184.15 53.91 15.9 White Non-Hispanic/non- Latino15OCT2020 C4591001 1009 10091209 13 Female 149.86 43.27 19.2 White Non-Hispanic/non- Latino15OCT2020 C4591001 1009 10091212 13 Female 151.13 41.73 18.2 White Non-Hispanic/non- Latino16OCT2020 C4591001 1009 10091213 15 Male 179.07 58.55 18.2 White Non-Hispanic/non- Latino16OCT2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 32 FDA-CBER-2022-5812-0223405 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1009 10091216 12 Female 160.02 56.18 21.9 White Non-Hispanic/non- Latino16OCT2020 C4591001 1009 10091218 13 Female 162.56 59.91 22.6 White Non-Hispanic/non- Latino16OCT2020 C4591001 1009 10091220 15 Male 179.58 53.18 16.5 White Non-Hispanic/non- Latino19OCT2020 C4591001 1009 10091221 14 Female 162.56 47.73 18 White Non-Hispanic/non- Latino19OCT2020 C4591001 1009 10091223# 14 Male 161.29 70.91 27.2 White Non-Hispanic/non- Latino19OCT2020 C4591001 1009 10091226 15 Male 172.72 73.64 24.6 White Non-Hispanic/non- Latino20OCT2020 C4591001 1009 10091227 15 Male 172.72 58.18 19.5 White Non-Hispanic/non- Latino20OCT2020 C4591001 1009 10091229 12 Female 166.37 57 20.5 White Non-Hispanic/non- Latino20OCT2020 C4591001 1009 10091231 15 Male 167.64 57.82 20.5 Asian Non-Hispanic/non- Latino20OCT2020 C4591001 1009 10091233 12 Male 151.13 34.09 14.9 White Non-Hispanic/non- Latino21OCT2020 C4591001 1009 10091234 13 Male 162.56 50.64 19.1 White Hispanic/Latino 21OCT2020 C4591001 1009 10091237 14 Female 157.48 60.36 24.3 White Non-Hispanic/non- Latino21OCT2020 C4591001 1009 10091238 15 Male 180.34 65.91 20.2 White Non-Hispanic/non- Latino21OCT2020 C4591001 1009 10091240# 13 Male 162.56 68.64 25.9 White Non-Hispanic/non- Latino21OCT2020 C4591001 1009 10091246 13 Male 157.48 35 14.1 White Non-Hispanic/non- Latino22OCT2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 33 FDA-CBER-2022-5812-0223406 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1009 10091247 12 Male 170.18 70.18 24.2 White Non-Hispanic/non- Latino22OCT2020 C4591001 1009 10091249 15 Female 158.75 70.91 28.1 White Non-Hispanic/non- Latino22OCT2020 C4591001 1009 10091250 13 Female 161.29 54.09 20.7 White Non-Hispanic/non- Latino22OCT2020 C4591001 1009 10091265# 14 Male 181.61 119.27 36.1 White Non-Hispanic/non- Latino01DEC2020 C4591001 1009 10091266 15 Female 165.1 77.55 28.4 White Non-Hispanic/non- Latino01DEC2020 C4591001 1009 10091267 13 Male 144.78 49.82 23.7 White Non-Hispanic/non- Latino01DEC2020 C4591001 1009 10091269 15 Male 172.72 55.36 18.5 White Non-Hispanic/non- Latino01DEC2020 C4591001 1009 10091270 12 Male 157.48 49.55 19.9 White Non-Hispanic/non- Latino01DEC2020 C4591001 1009 10091272 12 Male 160.02 43.18 16.8 White Non-Hispanic/non- Latino02DEC2020 C4591001 1009 10091273 15 Male 167.64 40.36 14.3 White Non-Hispanic/non- Latino02DEC2020 C4591001 1009 10091274 12 Male 152.4 41.82 18 White Non-Hispanic/non- Latino02DEC2020 C4591001 1009 10091275 15 Male 180.34 63.73 19.6 White Non-Hispanic/non- Latino02DEC2020 C4591001 1009 10091277# 13 Male 166.37 82.27 29.7 White Hispanic/Latino 03DEC2020 C4591001 1009 10091280 12 Female 157.48 40.55 16.3 White Non-Hispanic/non- Latino03DEC2020 C4591001 1009 10091281 14 Male 163.83 42.73 15.9 White Non-Hispanic/non- Latino03DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 34 FDA-CBER-2022-5812-0223407 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1009 10091282 14 Male 180.34 65.45 20.1 White Non-Hispanic/non- Latino03DEC2020 C4591001 1009 10091283 13 Female 166.37 55.27 19.9 White Non-Hispanic/non- Latino03DEC2020 C4591001 1009 10091284 15 Male 179.07 58.55 18.2 White Non-Hispanic/non- Latino03DEC2020 C4591001 1009 10091287 15 Female 172.72 47.27 15.8 White Non-Hispanic/non- Latino04DEC2020 C4591001 1009 10091288 13 Male 162.56 49.09 18.5 White Non-Hispanic/non- Latino04DEC2020 C4591001 1009 10091289 13 Female 165.1 60.45 22.1 White Non-Hispanic/non- Latino04DEC2020 C4591001 1009 10091292 15 Male 175.26 62.55 20.3 White Non-Hispanic/non- Latino04DEC2020 C4591001 1009 10091293 14 Male 158.12 45.55 18.2 White Non-Hispanic/non- Latino04DEC2020 C4591001 1009 10091294 15 Female 170.18 51.55 17.8 White Hispanic/Latino 07DEC2020 C4591001 1009 10091295 12 Female 144.78 28.73 13.7 White Non-Hispanic/non- Latino07DEC2020 C4591001 1009 10091296 14 Male 171.45 58.73 19.9 White Non-Hispanic/non- Latino07DEC2020 C4591001 1009 10091297 14 Male 157.48 51.82 20.8 White Non-Hispanic/non- Latino07DEC2020 C4591001 1009 10091298 14 Male 170.18 66.91 23.1 White Non-Hispanic/non- Latino07DEC2020 C4591001 1009 10091300 13 Male 163.32 55.36 20.7 White Non-Hispanic/non- Latino07DEC2020 C4591001 1009 10091301 15 Female 165.74 58.64 21.3 White Non-Hispanic/non- Latino07DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 35 FDA-CBER-2022-5812-0223408 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1009 10091303 13 Female 162.56 48.55 18.3 White Hispanic/Latino 08DEC2020 C4591001 1009 10091304 13 Male 165.74 53.36 19.4 White Non-Hispanic/non- Latino08DEC2020 C4591001 1009 10091305 15 Female 170.18 61.27 21.1 White Non-Hispanic/non- Latino08DEC2020 C4591001 1009 10091306 14 Female 170.18 62.82 21.6 White Non-Hispanic/non- Latino08DEC2020 C4591001 1009 10091307# 15 Female 165.1 97 35.5 White Non-Hispanic/non- Latino09DEC2020 C4591001 1009 10091308 13 Male 166.37 43.36 15.6 White Non-Hispanic/non- Latino09DEC2020 C4591001 1009 10091309 13 Male 160.02 52.45 20.4 White Non-Hispanic/non- Latino09DEC2020 C4591001 1009 10091310 15 Female 162.56 61.64 23.3 White Non-Hispanic/non- Latino09DEC2020 C4591001 1009 10091311 13 Male 168.91 34.18 12 White Non-Hispanic/non- Latino09DEC2020 C4591001 1009 10091312 12 Male 157.48 45.91 18.5 White Non-Hispanic/non- Latino09DEC2020 C4591001 1009 10091313 15 Male 172.72 73.91 24.7 White Non-Hispanic/non- Latino09DEC2020 C4591001 1009 10091314 15 Male 180.34 60.64 18.6 White Non-Hispanic/non- Latino09DEC2020 C4591001 1009 10091315 13 Male 180.34 63.36 19.4 White Non-Hispanic/non- Latino09DEC2020 C4591001 1009 10091316 15 Male 177.8 66.82 21.1 White Non-Hispanic/non- Latino09DEC2020 C4591001 1009 10091317# 13 Female 153.67 67.45 28.5 White Non-Hispanic/non- Latino10DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 36 FDA-CBER-2022-5812-0223409 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1009 10091318 14 Female 170.18 52 17.9 White Non-Hispanic/non- Latino10DEC2020 C4591001 1009 10091319 15 Male 175.9 52.55 16.9 White Non-Hispanic/non- Latino10DEC2020 C4591001 1009 10091320 14 Male 168.91 61.18 21.4 White Hispanic/Latino 10DEC2020 C4591001 1009 10091321 12 Female 161.29 48.18 18.5 White Non-Hispanic/non- Latino10DEC2020 C4591001 1009 10091322 12 Male 154.94 42.36 17.6 White Non-Hispanic/non- Latino10DEC2020 C4591001 1009 10091323 15 Female 166.37 61.64 22.2 White Non-Hispanic/non- Latino10DEC2020 C4591001 1009 10091324 15 Female 177.8 71.73 22.6 White Non-Hispanic/non- Latino11DEC2020 C4591001 1009 10091325 12 Male 161.29 42.27 16.2 White Non-Hispanic/non- Latino11DEC2020 C4591001 1009 10091326 12 Female 167.64 47.64 16.9 White Non-Hispanic/non- Latino11DEC2020 C4591001 1009 10091328 13 Female 149.86 44 19.5 White Non-Hispanic/non- Latino11DEC2020 C4591001 1009 10091329 13 Female 154.94 57.82 24 White Non-Hispanic/non- Latino11DEC2020 C4591001 1009 10091330 13 Female 154.94 49.09 20.4 White Non-Hispanic/non- Latino11DEC2020 C4591001 1009 10091331 13 Female 167.64 61.91 22 White Non-Hispanic/non- Latino11DEC2020 C4591001 1009 10091332 15 Female 181.61 84.45 25.5 White Non-Hispanic/non- Latino11DEC2020 C4591001 1009 10091333 14 Male 175.26 71.73 23.3 White Non-Hispanic/non- Latino11DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 37 FDA-CBER-2022-5812-0223410 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1009 10091334 13 Female 149.86 47.18 21 White Non-Hispanic/non- Latino11DEC2020 C4591001 1009 10091335 15 Female 169.55 59.09 20.5 White Non-Hispanic/non- Latino11DEC2020 C4591001 1009 10091336 13 Male 158.24 49.09 19.6 White Non-Hispanic/non- Latino11DEC2020 C4591001 1009 10091337 12 Male 158.75 45.64 18.1 White Non-Hispanic/non- Latino14DEC2020 C4591001 1009 10091338 15 Female 171.45 52 17.7 White Non-Hispanic/non- Latino14DEC2020 C4591001 1009 10091339 14 Female 166.37 56.82 20.5 White Non-Hispanic/non- Latino14DEC2020 C4591001 1009 10091340# 15 Female 165.1 107.36 39.3 White Non-Hispanic/non- Latino14DEC2020 C4591001 1009 10091341 13 Male 153.67 38 16.1 White Non-Hispanic/non- Latino14DEC2020 C4591001 1009 10091342 15 Male 175.26 61.64 20 White Non-Hispanic/non- Latino14DEC2020 C4591001 1009 10091343 13 Female 142.24 40.45 20 White Non-Hispanic/non- Latino15DEC2020 C4591001 1009 10091344 15 Male 175.26 65.91 21.4 White Non-Hispanic/non- Latino15DEC2020 C4591001 1009 10091345# 12 Male 153.67 58 24.5 Multiracial Non-Hispanic/non- Latino15DEC2020 C4591001 1009 10091346 15 Male 172.72 79.55 26.6 Multiracial Non-Hispanic/non- Latino15DEC2020 C4591001 1009 10091347 13 Female 160.02 51.45 20.1 White Non-Hispanic/non- Latino15DEC2020 C4591001 1009 10091348 14 Female 162.56 59.18 22.3 White Non-Hispanic/non- Latino15DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 38 FDA-CBER-2022-5812-0223411 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1009 10091349 15 Female 160.02 56.73 22.1 White Non-Hispanic/non- Latino15DEC2020 C4591001 1009 10091350# 14 Female 160.02 71.27 27.8 White Non-Hispanic/non- Latino16DEC2020 C4591001 1009 10091351 12 Female 154.94 40.82 17 White Non-Hispanic/non- Latino16DEC2020 C4591001 1009 10091353 12 Female 149.86 46.36 20.6 White Non-Hispanic/non- Latino16DEC2020 C4591001 1009 10091354 14 Female 167.64 54.45 19.3 White Non-Hispanic/non- Latino16DEC2020 C4591001 1009 10091355 12 Male 151.13 40.36 17.6 White Non-Hispanic/non- Latino16DEC2020 C4591001 1009 10091356 13 Female 165.61 41.64 15.1 White Non-Hispanic/non- Latino16DEC2020 C4591001 1009 10091357# 15 Male 187.96 101.36 28.6 White Non-Hispanic/non- Latino17DEC2020 C4591001 1009 10091358 14 Female 158.75 44.55 17.6 White Non-Hispanic/non- Latino17DEC2020 C4591001 1009 10091359 13 Male 156.97 54.64 22.1 White Non-Hispanic/non- Latino17DEC2020 C4591001 1009 10091360 15 Female 156.21 67 27.4 White Non-Hispanic/non- Latino17DEC2020 C4591001 1009 10091361 13 Female 165.1 62.91 23 White Non-Hispanic/non- Latino17DEC2020 C4591001 1009 10091362 12 Male 172.72 53.27 17.8 White Non-Hispanic/non- Latino17DEC2020 C4591001 1009 10091363 14 Male 185.42 62.36 18.1 White Non-Hispanic/non- Latino17DEC2020 C4591001 1009 10091364# 12 Female 162.56 83.09 31.4 White Non-Hispanic/non- Latino17DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 39 FDA-CBER-2022-5812-0223412 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1009 10091365 12 Male 167.64 60.18 21.4 White Non-Hispanic/non- Latino17DEC2020 C4591001 1009 10091366 14 Female 170.82 72.18 24.7 White Non-Hispanic/non- Latino17DEC2020 C4591001 1009 10091369 12 Female 167.64 52 18.5 White Non-Hispanic/non- Latino18DEC2020 C4591001 1009 10091370 13 Female 168.91 48.27 16.9 White Hispanic/Latino 18DEC2020 C4591001 1009 10091371 13 Male 167.64 61.45 21.8 White Non-Hispanic/non- Latino18DEC2020 C4591001 1009 10091372 13 Male 167.64 64.73 23 White Non-Hispanic/non- Latino18DEC2020 C4591001 1009 10091373 14 Female 154.94 52.82 22 White Non-Hispanic/non- Latino18DEC2020 C4591001 1009 10091374 15 Male 153.67 60.55 25.6 White Non-Hispanic/non- Latino21DEC2020 C4591001 1009 10091375 13 Female 166.37 60.36 21.8 White Non-Hispanic/non- Latino21DEC2020 C4591001 1009 10091376# 12 Male 168.91 90.45 31.6 White Non-Hispanic/non- Latino21DEC2020 C4591001 1009 10091377 12 Male 160.02 47.82 18.6 White Non-Hispanic/non- Latino21DEC2020 C4591001 1009 10091378 14 Female 162.56 49.55 18.7 White Non-Hispanic/non- Latino21DEC2020 C4591001 1009 10091379 13 Female 157.48 42.64 17.2 White Non-Hispanic/non- Latino22DEC2020 C4591001 1009 10091380 14 Male 172.72 60.09 20.1 White Non-Hispanic/non- Latino29DEC2020 C4591001 1009 10091381 12 Female 151.13 39.36 17.2 White Non-Hispanic/non- Latino31DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 40 FDA-CBER-2022-5812-0223413 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1009 10091382 14 Female 160.02 71 27.7 White Hispanic/Latino 04JAN2021 C4591001 1009 10091383 15 Male 163.83 53.73 20 White Non-Hispanic/non- Latino05JAN2021 C4591001 1009 10091384 15 Female 167.64 51.73 18.4 White Non-Hispanic/non- Latino05JAN2021 C4591001 1009 10091385# 14 Male 158.24 70.27 28 White Non-Hispanic/non- Latino05JAN2021 C4591001 1009 10091386 14 Male 166.37 51.55 18.6 White Non-Hispanic/non- Latino06JAN2021 C4591001 1009 10091387 12 Male 173.99 57.64 19 White Non-Hispanic/non- Latino06JAN2021 C4591001 1009 10091388 13 Male 149.86 43 19.1 White Non-Hispanic/non- Latino06JAN2021 C4591001 1009 10091389 15 Male 165.1 58.73 21.5 White Hispanic/Latino 06JAN2021 C4591001 1009 10091390 14 Female 162.56 56.55 21.4 White Non-Hispanic/non- Latino07JAN2021 C4591001 1009 10091391 14 Male 170.18 52 17.9 White Non-Hispanic/non- Latino07JAN2021 C4591001 1009 10091392 12 Female 156.21 50.82 20.8 White Non-Hispanic/non- Latino07JAN2021 C4591001 1009 10091393 14 Male 171.45 59.45 20.2 White Non-Hispanic/non- Latino07JAN2021 C4591001 1009 10091394 15 Male 170.18 58.45 20.1 White Non-Hispanic/non- Latino07JAN2021 C4591001 1009 10091395 13 Male 161.29 46.27 17.7 White Non-Hispanic/non- Latino07JAN2021 C4591001 1009 10091396 15 Male 167.64 55.73 19.8 White Non-Hispanic/non- Latino07JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 41 FDA-CBER-2022-5812-0223414 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1009 10091398 15 Female 160.02 48.45 18.9 White Non-Hispanic/non- Latino07JAN2021 C4591001 1009 10091399 12 Female 152.4 38.86 16.7 White Non-Hispanic/non- Latino08JAN2021 C4591001 1009 10091400 12 Male 154.31 41.64 17.4 White Non-Hispanic/non- Latino08JAN2021 C4591001 1009 10091401 12 Male 151.13 40.18 17.6 White Non-Hispanic/non- Latino08JAN2021 C4591001 1009 10091402 14 Female 157.48 42.36 17 White Hispanic/Latino 08JAN2021 C4591001 1009 10091403# 15 Female 179.07 102.55 31.9 White Non-Hispanic/non- Latino08JAN2021 C4591001 1009 10091404 12 Female 149.86 40.32 17.9 White Non-Hispanic/non- Latino08JAN2021 C4591001 1009 10091405 15 Female 160.02 50 19.5 White Non-Hispanic/non- Latino08JAN2021 C4591001 1009 10091406 15 Male 173.99 53.18 17.5 White Non-Hispanic/non- Latino08JAN2021 C4591001 1009 10091407 13 Female 167.64 50.64 18 Asian Non-Hispanic/non- Latino11JAN2021 C4591001 1009 10091408 13 Female 166.37 42.45 15.3 White Non-Hispanic/non- Latino11JAN2021 C4591001 1009 10091409 14 Female 172.72 50 16.7 White Non-Hispanic/non- Latino11JAN2021 C4591001 1009 10091410 12 Female 161.29 45.36 17.4 White Non-Hispanic/non- Latino12JAN2021 C4591001 1009 10091411 15 Male 171.45 50.82 17.3 White Non-Hispanic/non- Latino12JAN2021 C4591001 1009 10091412 15 Male 165.1 52.27 19.1 White Non-Hispanic/non- Latino12JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 42 FDA-CBER-2022-5812-0223415 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1009 10091413 13 Female 156.21 50.91 20.8 White Non-Hispanic/non- Latino12JAN2021 C4591001 1009 10091414 14 Female 176.53 61.91 19.8 White Non-Hispanic/non- Latino12JAN2021 C4591001 1013 10131821# 14 Male 164.7 74.8 27.6 Black or African American Non-Hispanic/non- Latino30NOV2020 C4591001 1013 10131822 15 Female 160 54.8 21.4 Black or African American Non-Hispanic/non- Latino30NOV2020 C4591001 1013 10131823# 15 Female 160 118.2 46.2 Black or African American Non-Hispanic/non- Latino01DEC2020 C4591001 1013 10131824 14 Female 157.5 54.5 22 Black or African American Non-Hispanic/non- Latino01DEC2020 C4591001 1013 10131826 14 Male 167.6 56.2 20 White Hispanic/Latino 01DEC2020 C4591001 1013 10131828 14 Male 162.5 47 17.8 White Hispanic/Latino 02DEC2020 C4591001 1013 10131830 14 Female 172.1 57.2 19.3 White Non-Hispanic/non- Latino02DEC2020 C4591001 1013 10131835 14 Female 161.5 50.7 19.4 Black or African American Non-Hispanic/non- Latino02DEC2020 C4591001 1013 10131836# 12 Female 154 77.7 32.8 Black or African American Non-Hispanic/non- Latino02DEC2020 C4591001 1013 10131839 14 Female 167.6 53.35 19 White Non-Hispanic/non- Latino02DEC2020 C4591001 1013 10131841 13 Female 163 64.4 24.2 Black or African American Non-Hispanic/non- Latino02DEC2020 C4591001 1013 10131842 15 Female 157.5 51.9 20.9 Black or African American Non-Hispanic/non- Latino02DEC2020 C4591001 1013 10131843 14 Male 179.1 72 22.4 Black or African American Non-Hispanic/non- Latino02DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 43 FDA-CBER-2022-5812-0223416 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1013 10131844# 13 Male 164 69.15 25.7 Black or African American Non-Hispanic/non- Latino02DEC2020 C4591001 1013 10131845 12 Female 157.4 55.3 22.3 White Non-Hispanic/non- Latino03DEC2020 C4591001 1013 10131846 15 Male 178.4 76.9 24.2 White Non-Hispanic/non- Latino03DEC2020 C4591001 1013 10131848 12 Male 175.2 55 17.9 White Non-Hispanic/non- Latino03DEC2020 C4591001 1013 10131850 15 Female 170.1 75.8 26.2 White Non-Hispanic/non- Latino03DEC2020 C4591001 1013 10131851 15 Female 164 58.6 21.8 Multiracial Non-Hispanic/non- Latino07DEC2020 C4591001 1013 10131852 14 Female 162.5 52.6 19.9 White Non-Hispanic/non- Latino07DEC2020 C4591001 1013 10131855 14 Male 162 52.05 19.8 White Non-Hispanic/non- Latino08DEC2020 C4591001 1013 10131856 15 Male 180.5 71.05 21.8 White Non-Hispanic/non- Latino09DEC2020 C4591001 1013 10131858 13 Female 154.3 40.8 17.1 White Non-Hispanic/non- Latino09DEC2020 C4591001 1013 10131859 15 Male 171.1 50.5 17.3 White Non-Hispanic/non- Latino09DEC2020 C4591001 1013 10131860 13 Male 171.5 72.6 24.7 White Hispanic/Latino 09DEC2020 C4591001 1013 10131861 12 Male 153.4 39.6 16.8 Black or African American Non-Hispanic/non- Latino10DEC2020 C4591001 1013 10131862 13 Female 162.5 68 25.8 White Hispanic/Latino 10DEC2020 C4591001 1013 10131863 14 Female 164.8 48.5 17.9 White Non-Hispanic/non- Latino10DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 44 FDA-CBER-2022-5812-0223417 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1013 10131865# 13 Male 175.6 93.2 30.2 White Hispanic/Latino 14DEC2020 C4591001 1013 10131866# 15 Male 175.3 86.2 28.1 White Hispanic/Latino 14DEC2020 C4591001 1013 10131867 12 Male 152.4 40.8 17.6 Black or African American Non-Hispanic/non- Latino17DEC2020 C4591001 1013 10131868 13 Female 166 53.9 19.6 Multiracial Non-Hispanic/non- Latino21DEC2020 C4591001 1013 10131869 14 Male 162 45.8 17.5 White Non-Hispanic/non- Latino21DEC2020 C4591001 1013 10131870 15 Male 171 64.3 22 White Non-Hispanic/non- Latino21DEC2020 C4591001 1013 10131871 13 Male 161.6 47.6 18.2 Multiracial Non-Hispanic/non- Latino21DEC2020 C4591001 1013 10131872 12 Male 154.9 38.2 15.9 Multiracial Hispanic/Latino 21DEC2020 C4591001 1013 10131873# 13 Female 154 71 29.9 Asian Non-Hispanic/non- Latino22DEC2020 C4591001 1013 10131874# 12 Male 165 72 26.4 Asian Non-Hispanic/non- Latino22DEC2020 C4591001 1013 10131875 14 Male 160 49.8 19.5 Multiracial Non-Hispanic/non- Latino22DEC2020 C4591001 1013 10131876 15 Female 155 44.6 18.6 Asian Non-Hispanic/non- Latino22DEC2020 C4591001 1013 10131877 13 Male 162 65.15 24.8 White Non-Hispanic/non- Latino23DEC2020 C4591001 1013 10131878 12 Male 149.9 46 20.5 White Hispanic/Latino 23DEC2020 C4591001 1013 10131879 15 Male 178.3 54.7 17.2 White Hispanic/Latino 23DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 45 FDA-CBER-2022-5812-0223418 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1013 10131880# 14 Male 164.2 75.2 27.9 White Hispanic/Latino 23DEC2020 C4591001 1013 10131881 14 Male 170.4 53.8 18.5 White Non-Hispanic/non- Latino28DEC2020 C4591001 1013 10131882 15 Male 184 73.7 21.8 White Non-Hispanic/non- Latino30DEC2020 C4591001 1013 10131883 14 Female 157.7 40.5 16.3 White Non-Hispanic/non- Latino31DEC2020 C4591001 1013 10131884 14 Female 160 50 19.5 Asian Non-Hispanic/non- Latino07JAN2021 C4591001 1013 10131885 14 Female 160 43.9 17.1 White Hispanic/Latino 07JAN2021 C4591001 1013 10131886 12 Male 158.3 49.6 19.8 White Non-Hispanic/non- Latino07JAN2021 C4591001 1016 10161307# 13 Female 160.02 128.64 50.1 Black or African American Non-Hispanic/non- Latino15OCT2020 C4591001 1016 10161308 13 Male 175.26 51.91 16.9 White Non-Hispanic/non- Latino15OCT2020 C4591001 1016 10161309 14 Male 179.07 60.91 19 White Non-Hispanic/non- Latino15OCT2020 C4591001 1016 10161310 13 Male 165.1 60.82 22.3 White Non-Hispanic/non- Latino15OCT2020 C4591001 1016 10161311# 15 Male 168.91 87.73 30.7 White Hispanic/Latino 15OCT2020 C4591001 1016 10161314 13 Female 152.4 52.18 22.4 White Non-Hispanic/non- Latino16OCT2020 C4591001 1016 10161315 14 Female 158.75 57.05 22.6 White Non-Hispanic/non- Latino16OCT2020 C4591001 1016 10161316 15 Male 175.77 70 22.6 White Non-Hispanic/non- Latino16OCT2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 46 FDA-CBER-2022-5812-0223419 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1016 10161318# 14 Male 161.29 71 27.2 White Non-Hispanic/non- Latino16OCT2020 C4591001 1016 10161319# 12 Female 159.51 111.18 43.6 White Hispanic/Latino 16OCT2020 C4591001 1016 10161320 14 Male 168.91 68.18 23.8 White Non-Hispanic/non- Latino19OCT2020 C4591001 1016 10161322 14 Female 160.02 65.45 25.5 White Hispanic/Latino 19OCT2020 C4591001 1016 10161323 13 Female 165.1 67.82 24.8 Black or African American Non-Hispanic/non- Latino19OCT2020 C4591001 1016 10161324 15 Female 165.1 64.55 23.6 Black or African American Non-Hispanic/non- Latino19OCT2020 C4591001 1016 10161325 14 Female 170.18 79.55 27.4 White Non-Hispanic/non- Latino19OCT2020 C4591001 1016 10161326 14 Male 175.26 68.45 22.2 White Non-Hispanic/non- Latino20OCT2020 C4591001 1016 10161327 12 Male 170.18 52.73 18.2 White Non-Hispanic/non- Latino20OCT2020 C4591001 1016 10161329# 14 Male 176.53 108.18 34.6 White Non-Hispanic/non- Latino20OCT2020 C4591001 1016 10161330 13 Female 155.45 45.95 19 White Non-Hispanic/non- Latino20OCT2020 C4591001 1016 10161331 12 Female 161.29 65.27 25 White Non-Hispanic/non- Latino20OCT2020 C4591001 1016 10161332 14 Male 162.56 68.64 25.9 Black or African American Non-Hispanic/non- Latino21OCT2020 C4591001 1016 10161334 14 Female 177.8 78.73 24.8 White Non-Hispanic/non- Latino21OCT2020 C4591001 1016 10161335# 13 Female 170.18 101.73 35 White Non-Hispanic/non- Latino21OCT2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 47 FDA-CBER-2022-5812-0223420 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1016 10161336 15 Female 161.29 56 21.5 White Non-Hispanic/non- Latino21OCT2020 C4591001 1016 10161337 15 Female 162.56 53.91 20.4 White Non-Hispanic/non- Latino21OCT2020 C4591001 1016 10161338 12 Male 162.56 45 17 Black or African American Non-Hispanic/non- Latino22OCT2020 C4591001 1016 10161339 13 Male 160.02 49.09 19.1 White Non-Hispanic/non- Latino22OCT2020 C4591001 1016 10161340# 12 Male 163.83 84.64 31.5 White Non-Hispanic/non- Latino22OCT2020 C4591001 1016 10161343 14 Male 173.99 79.55 26.2 White Non-Hispanic/non- Latino22OCT2020 C4591001 1016 10161344 15 Female 152.4 51.36 22.1 White Non-Hispanic/non- Latino22OCT2020 C4591001 1016 10161350 14 Male 170.18 53.18 18.3 White Non-Hispanic/non- Latino30NOV2020 C4591001 1016 10161351 14 Female 162.05 55.82 21.2 White Non-Hispanic/non- Latino30NOV2020 C4591001 1016 10161352 15 Female 155.7 44.82 18.4 White Non-Hispanic/non- Latino30NOV2020 C4591001 1016 10161353 13 Female 147.32 33.45 15.4 White Non-Hispanic/non- Latino30NOV2020 C4591001 1016 10161354 14 Female 171.45 56.36 19.1 White Non-Hispanic/non- Latino02DEC2020 C4591001 1016 10161356 13 Male 163.83 55.82 20.8 White Hispanic/Latino 02DEC2020 C4591001 1016 10161357 12 Male 172.72 62.27 20.8 White Non-Hispanic/non- Latino02DEC2020 C4591001 1016 10161358 13 Male 172.72 56.27 18.8 White Non-Hispanic/non- Latino03DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 48 FDA-CBER-2022-5812-0223421 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1016 10161361 13 Male 167.64 48.91 17.4 White Non-Hispanic/non- Latino04DEC2020 C4591001 1016 10161362 12 Male 148.59 30.91 14 Black or African American Non-Hispanic/non- Latino04DEC2020 C4591001 1016 10161363 15 Female 162.56 59.64 22.5 White Non-Hispanic/non- Latino08DEC2020 C4591001 1016 10161364 15 Female 158.75 46.36 18.4 White Non-Hispanic/non- Latino09DEC2020 C4591001 1016 10161365# 13 Female 163.83 76.55 28.5 Multiracial Non-Hispanic/non- Latino10DEC2020 C4591001 1016 10161366 12 Male 162.56 65.82 24.9 White Non-Hispanic/non- Latino15DEC2020 C4591001 1016 10161367# 12 Female 165.1 87.36 32 White Non-Hispanic/non- Latino29DEC2020 C4591001 1016 10161368 12 Female 148.08 35 15.9 White Non-Hispanic/non- Latino30DEC2020 C4591001 1016 10161369 12 Female 140.97 37.55 18.9 White Hispanic/Latino 30DEC2020 C4591001 1016 10161370 15 Male 173.99 63.18 20.8 Multiracial Non-Hispanic/non- Latino04JAN2021 C4591001 1016 10161371 12 Female 167.64 55.45 19.7 White Non-Hispanic/non- Latino04JAN2021 C4591001 1016 10161372# 14 Female 162.56 75.64 28.6 White Non-Hispanic/non- Latino05JAN2021 C4591001 1016 10161373# 14 Female 160.02 75.09 29.3 White Non-Hispanic/non- Latino05JAN2021 C4591001 1016 10161374 13 Female 160.02 49.45 19.3 White Non-Hispanic/non- Latino06JAN2021 C4591001 1016 10161375 14 Female 165.1 46.73 17.1 White Non-Hispanic/non- Latino06JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 49 FDA-CBER-2022-5812-0223422 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1016 10161376 15 Female 168.91 70.36 24.6 White Non-Hispanic/non- Latino07JAN2021 C4591001 1016 10161377 13 Female 163.83 55.36 20.6 White Non-Hispanic/non- Latino07JAN2021 C4591001 1016 10161378 12 Male 153.16 37.27 15.9 White Non-Hispanic/non- Latino07JAN2021 C4591001 1016 10161379 13 Male 176.53 77.73 24.9 White Non-Hispanic/non- Latino07JAN2021 C4591001 1016 10161381 15 Male 184.91 70.09 20.5 White Non-Hispanic/non- Latino08JAN2021 C4591001 1016 10161382 12 Male 172.72 62.18 20.8 Asian Non-Hispanic/non- Latino08JAN2021 C4591001 1016 10161383 12 Male 175.26 71 23.1 Asian Non-Hispanic/non- Latino08JAN2021 C4591001 1016 10161384 13 Female 172.72 57 19.1 White Non-Hispanic/non- Latino08JAN2021 C4591001 1016 10161385 14 Male 177.29 53.64 17 Black or African American Non-Hispanic/non- Latino08JAN2021 C4591001 1016 10161386 13 Female 152.4 36.82 15.8 White Non-Hispanic/non- Latino08JAN2021 C4591001 1016 10161387# 14 Female 170.18 89.55 30.9 White Non-Hispanic/non- Latino08JAN2021 C4591001 1016 10161388# 15 Female 166.37 80.82 29.1 White Non-Hispanic/non- Latino11JAN2021 C4591001 1039 10391246 15 Male 183.5 71.8 21.3 White Non-Hispanic/non- Latino01DEC2020 C4591001 1039 10391247 12 Male 149 33.6 15.1 White Non-Hispanic/non- Latino01DEC2020 C4591001 1039 10391250 14 Female 167.5 60.6 21.6 White Non-Hispanic/non- Latino04DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 50 FDA-CBER-2022-5812-0223423 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1039 10391251 15 Female 165.6 53.5 19.5 Asian Non-Hispanic/non- Latino07DEC2020 C4591001 1039 10391252 15 Male 180.1 87.2 26.9 White Non-Hispanic/non- Latino07DEC2020 C4591001 1039 10391253# 12 Female 159.5 68.6 27 White Non-Hispanic/non- Latino07DEC2020 C4591001 1039 10391255 12 Male 174.1 73.6 24.3 White Non-Hispanic/non- Latino07DEC2020 C4591001 1039 10391256 12 Male 167.5 51.6 18.4 White Non-Hispanic/non- Latino07DEC2020 C4591001 1039 10391258 13 Female 167.5 75.8 27 White Non-Hispanic/non- Latino07DEC2020 C4591001 1039 10391259# 13 Male 168 77.5 27.5 White Non-Hispanic/non- Latino07DEC2020 C4591001 1039 10391260 14 Male 169.5 64.1 22.3 White Non-Hispanic/non- Latino07DEC2020 C4591001 1039 10391262 14 Female 158 51.3 20.5 White Hispanic/Latino 08DEC2020 C4591001 1039 10391263 13 Male 177.4 69.8 22.2 White Non-Hispanic/non- Latino08DEC2020 C4591001 1039 10391264 12 Female 158.5 43.8 17.4 Asian Hispanic/Latino 08DEC2020 C4591001 1039 10391265 12 Male 152.7 40.4 17.3 Asian Hispanic/Latino 08DEC2020 C4591001 1039 10391266 12 Male 158 39.1 15.7 White Non-Hispanic/non- Latino08DEC2020 C4591001 1039 10391267 15 Female 164.3 53.1 19.7 White Non-Hispanic/non- Latino08DEC2020 C4591001 1039 10391268 13 Female 160 47.1 18.4 White Non-Hispanic/non- Latino08DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 51 FDA-CBER-2022-5812-0223424 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1039 10391269 12 Male 162.1 45 17.1 White Non-Hispanic/non- Latino08DEC2020 C4591001 1039 10391270 13 Female 166.6 58.1 20.9 White Non-Hispanic/non- Latino09DEC2020 C4591001 1039 10391271 14 Female 169 63.6 22.3 White Non-Hispanic/non- Latino09DEC2020 C4591001 1039 10391272 12 Male 165.5 43.7 16 White Non-Hispanic/non- Latino09DEC2020 C4591001 1039 10391273 12 Female 165.5 45.2 16.5 White Non-Hispanic/non- Latino09DEC2020 C4591001 1039 10391274 13 Male 165.5 48.5 17.7 White Non-Hispanic/non- Latino16DEC2020 C4591001 1039 10391275 12 Male 160 40.4 15.8 White Hispanic/Latino 16DEC2020 C4591001 1039 10391276# 13 Male 174 82 27.1 Asian Non-Hispanic/non- Latino16DEC2020 C4591001 1039 10391277 14 Female 165.3 45.8 16.8 Black or African American Non-Hispanic/non- Latino16DEC2020 C4591001 1039 10391278 12 Male 152.3 39.4 17 White Non-Hispanic/non- Latino16DEC2020 C4591001 1039 10391279 14 Female 151 43.2 18.9 White Non-Hispanic/non- Latino16DEC2020 C4591001 1039 10391280# 13 Female 156.9 68.9 28 White Non-Hispanic/non- Latino17DEC2020 C4591001 1039 10391281# 15 Female 171.5 87.6 29.8 White Non-Hispanic/non- Latino17DEC2020 C4591001 1039 10391282 13 Male 165 48.1 17.7 White Hispanic/Latino 18DEC2020 C4591001 1039 10391283 15 Male 170.5 51.9 17.9 White Non-Hispanic/non- Latino18DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 52 FDA-CBER-2022-5812-0223425 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1039 10391284 13 Male 169 59.7 20.9 White Non-Hispanic/non- Latino18DEC2020 C4591001 1039 10391285 13 Female 156.1 40.8 16.7 White Non-Hispanic/non- Latino18DEC2020 C4591001 1039 10391286 13 Female 152.2 40.6 17.5 White Non-Hispanic/non- Latino18DEC2020 C4591001 1039 10391287 14 Female 161.5 54.2 20.8 White Non-Hispanic/non- Latino18DEC2020 C4591001 1039 10391289 15 Male 177.5 64.3 20.4 White Non-Hispanic/non- Latino18DEC2020 C4591001 1039 10391290 12 Female 155.5 41.8 17.3 White Non-Hispanic/non- Latino18DEC2020 C4591001 1039 10391291 15 Female 167.5 63.8 22.7 White Hispanic/Latino 18DEC2020 C4591001 1039 10391292 13 Female 169 64.1 22.4 White Non-Hispanic/non- Latino18DEC2020 C4591001 1039 10391293 14 Male 168 63.3 22.4 White Non-Hispanic/non- Latino21DEC2020 C4591001 1039 10391294 13 Male 167.5 46.6 16.6 Asian Non-Hispanic/non- Latino21DEC2020 C4591001 1039 10391295# 13 Female 159.5 78.1 30.7 White Non-Hispanic/non- Latino29DEC2020 C4591001 1039 10391296 13 Male 158.4 47.2 18.8 White Not reported 29DEC2020 C4591001 1039 10391297 13 Male 168.6 49.1 17.3 White Hispanic/Latino 29DEC2020 C4591001 1039 10391298 14 Male 186.2 75.2 21.7 White Non-Hispanic/non- Latino29DEC2020 C4591001 1039 10391299 15 Male 176.4 63.3 20.3 White Non-Hispanic/non- Latino29DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 53 FDA-CBER-2022-5812-0223426 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1039 10391300 12 Male 153.4 44.2 18.8 White Hispanic/Latino 29DEC2020 C4591001 1039 10391301 14 Male 154.5 45 18.9 White Hispanic/Latino 29DEC2020 C4591001 1039 10391302 14 Male 170.6 47.3 16.3 White Non-Hispanic/non- Latino29DEC2020 C4591001 1039 10391303 13 Male 162 64.4 24.5 White Non-Hispanic/non- Latino29DEC2020 C4591001 1039 10391304 13 Male 167 41.1 14.7 White Non-Hispanic/non- Latino29DEC2020 C4591001 1039 10391305 13 Male 169.5 55.7 19.4 White Non-Hispanic/non- Latino06JAN2021 C4591001 1039 10391306 12 Male 155.5 51.6 21.3 White Non-Hispanic/non- Latino06JAN2021 C4591001 1039 10391307 15 Female 169.7 61.2 21.3 White Non-Hispanic/non- Latino06JAN2021 C4591001 1039 10391308 13 Female 155.1 42 17.5 White Non-Hispanic/non- Latino06JAN2021 C4591001 1039 10391309 14 Male 172.2 52.7 17.8 Asian Non-Hispanic/non- Latino07JAN2021 C4591001 1039 10391310# 13 Male 158 73.1 29.3 White Hispanic/Latino 07JAN2021 C4591001 1039 10391311 15 Male 167 65.7 23.6 White Non-Hispanic/non- Latino07JAN2021 C4591001 1039 10391312 13 Male 171 59.3 20.3 White Hispanic/Latino 07JAN2021 C4591001 1039 10391313 14 Male 175 53.1 17.3 White Non-Hispanic/non- Latino07JAN2021 C4591001 1039 10391314 14 Female 167.4 65.9 23.5 Asian Non-Hispanic/non- Latino07JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 54 FDA-CBER-2022-5812-0223427 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1039 10391315 14 Male 172.5 49.3 16.6 White Non-Hispanic/non- Latino07JAN2021 C4591001 1039 10391316 12 Female 156 48.5 19.9 White Non-Hispanic/non- Latino07JAN2021 C4591001 1039 10391317 12 Male 168.6 66.2 23.3 Asian Non-Hispanic/non- Latino07JAN2021 C4591001 1039 10391318 15 Female 163 66.8 25.1 White Non-Hispanic/non- Latino07JAN2021 C4591001 1039 10391319 12 Male 156.1 55.5 22.8 White Non-Hispanic/non- Latino08JAN2021 C4591001 1039 10391320 12 Female 167.1 49.1 17.6 White Non-Hispanic/non- Latino08JAN2021 C4591001 1039 10391321 12 Female 166 43.5 15.8 White Non-Hispanic/non- Latino08JAN2021 C4591001 1039 10391322 15 Female 164 47.7 17.7 White Hispanic/Latino 08JAN2021 C4591001 1039 10391323 13 Female 164 63 23.4 White Non-Hispanic/non- Latino08JAN2021 C4591001 1039 10391324 12 Female 155.4 58.1 24.1 White Non-Hispanic/non- Latino08JAN2021 C4591001 1039 10391325 13 Female 155.8 42.1 17.3 Asian Non-Hispanic/non- Latino11JAN2021 C4591001 1039 10391326 15 Male 177.7 65.5 20.7 Asian Non-Hispanic/non- Latino11JAN2021 C4591001 1039 10391327 15 Male 169 59.4 20.8 White Hispanic/Latino 11JAN2021 C4591001 1039 10391328 14 Female 164 67.5 25.1 White Non-Hispanic/non- Latino11JAN2021 C4591001 1039 10391329# 13 Male 168.1 76.2 27 White Non-Hispanic/non- Latino11JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 55 FDA-CBER-2022-5812-0223428 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1039 10391330 15 Male 182 67 20.2 White Non-Hispanic/non- Latino11JAN2021 C4591001 1039 10391331 13 Male 160 42.5 16.6 White Non-Hispanic/non- Latino12JAN2021 C4591001 1039 10391332 13 Female 156 38.7 15.9 White Non-Hispanic/non- Latino12JAN2021 C4591001 1039 10391333 15 Male 171.6 72 24.5 White Hispanic/Latino 12JAN2021 C4591001 1039 10391334 12 Male 149.1 38.9 17.5 White Hispanic/Latino 12JAN2021 C4591001 1039 10391335 15 Male 175 54.3 17.7 White Non-Hispanic/non- Latino12JAN2021 C4591001 1039 10391336 14 Male 177.4 62.2 19.8 White Non-Hispanic/non- Latino12JAN2021 C4591001 1039 10391337 15 Male 182.4 84.7 25.5 White Hispanic/Latino 12JAN2021 C4591001 1039 10391338 15 Female 150 48.9 21.7 White Hispanic/Latino 12JAN2021 C4591001 1039 10391339 12 Female 149.5 40.7 18.2 White Hispanic/Latino 12JAN2021 C4591001 1044 10441251 14 Female 160 59.1 23.1 White Non-Hispanic/non- Latino30NOV2020 C4591001 1044 10441252 13 Male 167.6 45.9 16.3 White Non-Hispanic/non- Latino30NOV2020 C4591001 1044 10441253 13 Male 163.8 46.8 17.4 White Hispanic/Latino 30NOV2020 C4591001 1044 10441255# 12 Male 156.2 67.2 27.5 White Non-Hispanic/non- Latino01DEC2020 C4591001 1044 10441256 14 Male 167.6 60.1 21.4 White Non-Hispanic/non- Latino01DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 56 FDA-CBER-2022-5812-0223429 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1044 10441257 14 Female 159.4 55 21.6 White Non-Hispanic/non- Latino01DEC2020 C4591001 1044 10441259 12 Female 150.5 43.4 19.2 Asian Non-Hispanic/non- Latino01DEC2020 C4591001 1044 10441260 15 Male 172.7 72.9 24.4 White Non-Hispanic/non- Latino01DEC2020 C4591001 1044 10441261 14 Female 160 67.2 26.2 White Non-Hispanic/non- Latino01DEC2020 C4591001 1044 10441263 13 Male 165.1 53 19.4 White Non-Hispanic/non- Latino07DEC2020 C4591001 1044 10441264# 14 Female 167.6 98.3 35 White Non-Hispanic/non- Latino07DEC2020 C4591001 1044 10441265 14 Male 157.5 37 14.9 White Non-Hispanic/non- Latino07DEC2020 C4591001 1044 10441266 14 Female 165.1 74.2 27.2 White Non-Hispanic/non- Latino08DEC2020 C4591001 1044 10441267 14 Male 170.2 58.6 20.2 White Non-Hispanic/non- Latino08DEC2020 C4591001 1044 10441268# 15 Male 180.3 129.2 39.7 White Non-Hispanic/non- Latino08DEC2020 C4591001 1044 10441270 13 Female 148.6 38.6 17.5 Not reported Hispanic/Latino 08DEC2020 C4591001 1044 10441271 15 Female 183.5 51.7 15.4 White Non-Hispanic/non- Latino08DEC2020 C4591001 1044 10441273 12 Female 149.9 46.5 20.7 White Non-Hispanic/non- Latino08DEC2020 C4591001 1044 10441274 15 Male 170.2 66.3 22.9 White Non-Hispanic/non- Latino08DEC2020 C4591001 1044 10441275 12 Female 168.9 53.4 18.7 White Non-Hispanic/non- Latino09DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 57 FDA-CBER-2022-5812-0223430 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1044 10441276 14 Male 177.8 56.2 17.8 White Non-Hispanic/non- Latino09DEC2020 C4591001 1044 10441277 15 Female 172.7 49.7 16.7 White Non-Hispanic/non- Latino09DEC2020 C4591001 1044 10441278# 13 Female 168.9 87.1 30.5 White Non-Hispanic/non- Latino09DEC2020 C4591001 1044 10441279 15 Female 160 55.5 21.7 White Non-Hispanic/non- Latino09DEC2020 C4591001 1044 10441280 15 Male 175.3 70.5 22.9 White Non-Hispanic/non- Latino09DEC2020 C4591001 1044 10441281 15 Male 171.5 54.4 18.5 White Non-Hispanic/non- Latino09DEC2020 C4591001 1044 10441282 15 Male 180.3 66.5 20.5 White Non-Hispanic/non- Latino09DEC2020 C4591001 1044 10441283 14 Male 171.5 48.1 16.4 White Non-Hispanic/non- Latino10DEC2020 C4591001 1044 10441284 15 Male 179.1 68.7 21.4 White Non-Hispanic/non- Latino10DEC2020 C4591001 1044 10441285 15 Female 157.5 58 23.4 White Non-Hispanic/non- Latino10DEC2020 C4591001 1044 10441286 15 Female 163.8 62.1 23.1 White Non-Hispanic/non- Latino11DEC2020 C4591001 1044 10441288 12 Female 165.7 29 10.6 White Non-Hispanic/non- Latino16DEC2020 C4591001 1044 10441289 13 Female 157.5 37.8 15.2 White Non-Hispanic/non- Latino16DEC2020 C4591001 1044 10441290 12 Female 152.4 42.5 18.3 Asian Non-Hispanic/non- Latino16DEC2020 C4591001 1044 10441291 13 Male 160 46.6 18.2 White Non-Hispanic/non- Latino17DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 58 FDA-CBER-2022-5812-0223431 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1044 10441292 15 Male 172.7 51.9 17.4 White Non-Hispanic/non- Latino17DEC2020 C4591001 1044 10441293 12 Male 162.6 58.8 22.2 White Non-Hispanic/non- Latino17DEC2020 C4591001 1044 10441294 14 Male 181.6 63.3 19.2 White Non-Hispanic/non- Latino17DEC2020 C4591001 1044 10441295 12 Male 154.9 45.7 19 White Non-Hispanic/non- Latino18DEC2020 C4591001 1044 10441296 13 Male 161.3 56.8 21.8 White Non-Hispanic/non- Latino22DEC2020 C4591001 1044 10441297 14 Female 168.9 50.7 17.8 White Non-Hispanic/non- Latino23DEC2020 C4591001 1044 10441298 14 Female 161.3 39.6 15.2 White Non-Hispanic/non- Latino23DEC2020 C4591001 1044 10441299 15 Male 188 74.8 21.2 White Non-Hispanic/non- Latino28DEC2020 C4591001 1044 10441300# 15 Male 180.3 95.5 29.4 White Non-Hispanic/non- Latino28DEC2020 C4591001 1044 10441301 15 Female 165.1 49.9 18.3 White Non-Hispanic/non- Latino29DEC2020 C4591001 1044 10441302 14 Female 170.8 58.2 20 White Non-Hispanic/non- Latino29DEC2020 C4591001 1044 10441303 15 Male 188 60.3 17.1 White Non-Hispanic/non- Latino29DEC2020 C4591001 1044 10441304 15 Female 167.6 57.5 20.5 White Non-Hispanic/non- Latino29DEC2020 C4591001 1044 10441306 12 Male 158.1 57.3 22.9 White Non-Hispanic/non- Latino30DEC2020 C4591001 1044 10441307 14 Male 168.9 62 21.7 White Non-Hispanic/non- Latino30DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 59 FDA-CBER-2022-5812-0223432 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1044 10441308 12 Male 165.1 44.9 16.5 White Non-Hispanic/non- Latino30DEC2020 C4591001 1044 10441309# 12 Male 167.6 74.2 26.4 White Non-Hispanic/non- Latino30DEC2020 C4591001 1044 10441310 13 Male 162.6 51.9 19.6 White Non-Hispanic/non- Latino30DEC2020 C4591001 1044 10441311 12 Female 157.5 46.7 18.8 White Non-Hispanic/non- Latino04JAN2021 C4591001 1044 10441312 14 Male 167.6 48.4 17.2 White Non-Hispanic/non- Latino04JAN2021 C4591001 1044 10441313 14 Female 166.4 48.5 17.5 White Non-Hispanic/non- Latino04JAN2021 C4591001 1044 10441314 14 Female 165.1 56.3 20.7 White Non-Hispanic/non- Latino04JAN2021 C4591001 1044 10441315 14 Female 172.7 56 18.8 White Non-Hispanic/non- Latino04JAN2021 C4591001 1044 10441316 15 Male 177.8 67.4 21.3 White Hispanic/Latino 04JAN2021 C4591001 1044 10441317 13 Female 167.6 51.5 18.3 White Non-Hispanic/non- Latino04JAN2021 C4591001 1044 10441318 14 Female 172.7 52.3 17.5 Black or African American Non-Hispanic/non- Latino05JAN2021 C4591001 1044 10441319 12 Male 172.7 53.3 17.9 Black or African American Non-Hispanic/non- Latino05JAN2021 C4591001 1044 10441320 15 Male 177.8 65.8 20.8 White Non-Hispanic/non- Latino05JAN2021 C4591001 1044 10441321# 14 Male 160 78.3 30.6 White Non-Hispanic/non- Latino05JAN2021 C4591001 1044 10441322# 14 Male 160 83.6 32.7 Asian Non-Hispanic/non- Latino05JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 60 FDA-CBER-2022-5812-0223433 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1044 10441323 15 Male 182.9 65.2 19.5 White Non-Hispanic/non- Latino05JAN2021 C4591001 1044 10441324 15 Female 168.9 59.6 20.9 White Non-Hispanic/non- Latino05JAN2021 C4591001 1044 10441325 12 Male 165.1 55.4 20.3 White Non-Hispanic/non- Latino05JAN2021 C4591001 1044 10441326 13 Female 157.5 40.8 16.4 White Non-Hispanic/non- Latino06JAN2021 C4591001 1044 10441327 15 Female 170.2 62.1 21.4 White Non-Hispanic/non- Latino06JAN2021 C4591001 1044 10441328 15 Female 160 60.1 23.5 White Non-Hispanic/non- Latino06JAN2021 C4591001 1044 10441329 12 Female 163.8 55.1 20.5 White Non-Hispanic/non- Latino06JAN2021 C4591001 1044 10441330 14 Female 159.8 44.9 17.6 White Non-Hispanic/non- Latino06JAN2021 C4591001 1044 10441331 12 Male 162.6 43.1 16.3 White Non-Hispanic/non- Latino06JAN2021 C4591001 1044 10441332 15 Male 173.4 58.6 19.5 White Non-Hispanic/non- Latino06JAN2021 C4591001 1044 10441333 13 Male 160 38.1 14.9 White Non-Hispanic/non- Latino06JAN2021 C4591001 1044 10441334 12 Female 157.5 45 18.1 White Hispanic/Latino 07JAN2021 C4591001 1044 10441335 15 Female 161.9 60.1 22.9 White Hispanic/Latino 07JAN2021 C4591001 1044 10441336 12 Female 157.5 41.3 16.6 Asian Non-Hispanic/non- Latino07JAN2021 C4591001 1044 10441337 13 Male 152.4 36.8 15.8 White Non-Hispanic/non- Latino08JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 61 FDA-CBER-2022-5812-0223434 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1044 10441338 13 Female 170.2 44.7 15.4 White Non-Hispanic/non- Latino08JAN2021 C4591001 1044 10441339 15 Female 171.5 55.1 18.7 Asian Non-Hispanic/non- Latino08JAN2021 C4591001 1044 10441340 13 Male 157.5 57.9 23.3 White Non-Hispanic/non- Latino08JAN2021 C4591001 1044 10441341 14 Male 165.1 49.4 18.1 White Non-Hispanic/non- Latino08JAN2021 C4591001 1044 10441342 13 Male 170.2 42.5 14.7 White Non-Hispanic/non- Latino09JAN2021 C4591001 1044 10441343 14 Male 162.6 39.9 15.1 Asian Non-Hispanic/non- Latino09JAN2021 C4591001 1044 10441344 15 Male 165.1 69.8 25.6 Asian Non-Hispanic/non- Latino09JAN2021 C4591001 1044 10441345 12 Female 157.5 38.3 15.4 White Non-Hispanic/non- Latino09JAN2021 C4591001 1044 10441346 12 Male 160 53.5 20.9 White Non-Hispanic/non- Latino09JAN2021 C4591001 1044 10441347 14 Female 157.5 59.1 23.8 White Non-Hispanic/non- Latino09JAN2021 C4591001 1044 10441348 13 Male 157.5 36.1 14.6 White Non-Hispanic/non- Latino09JAN2021 C4591001 1044 10441349 13 Male 170.2 72.2 24.9 White Non-Hispanic/non- Latino09JAN2021 C4591001 1044 10441350 15 Female 157.5 54.7 22.1 Asian Non-Hispanic/non- Latino09JAN2021 C4591001 1044 10441351 15 Male 180.3 81.3 25 White Non-Hispanic/non- Latino10JAN2021 C4591001 1044 10441352 15 Female 162.6 54 20.4 White Hispanic/Latino 10JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 62 FDA-CBER-2022-5812-0223435 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1044 10441353 13 Female 165.1 58.9 21.6 White Non-Hispanic/non- Latino10JAN2021 C4591001 1044 10441354 13 Female 160 42.9 16.8 White Non-Hispanic/non- Latino10JAN2021 C4591001 1044 10441355 14 Female 163.8 55.4 20.6 Asian Non-Hispanic/non- Latino10JAN2021 C4591001 1044 10441356 12 Male 163.8 42.4 15.8 White Non-Hispanic/non- Latino10JAN2021 C4591001 1044 10441357 13 Male 148.6 39.2 17.8 White Hispanic/Latino 10JAN2021 C4591001 1044 10441358 14 Male 174 45.4 15 Asian Non-Hispanic/non- Latino10JAN2021 C4591001 1044 10441359 15 Female 166.4 61.1 22.1 White Non-Hispanic/non- Latino11JAN2021 C4591001 1044 10441360 13 Male 177.8 55.9 17.7 White Non-Hispanic/non- Latino11JAN2021 C4591001 1044 10441361 15 Male 183.5 60.2 17.9 White Non-Hispanic/non- Latino11JAN2021 C4591001 1044 10441362 14 Male 182.9 54.2 16.2 White Non-Hispanic/non- Latino11JAN2021 C4591001 1044 10441363 13 Female 174 59.2 19.6 White Non-Hispanic/non- Latino11JAN2021 C4591001 1044 10441364 15 Female 156.2 61.5 25.2 White Non-Hispanic/non- Latino11JAN2021 C4591001 1044 10441365 15 Female 163.2 54.8 20.6 White Non-Hispanic/non- Latino11JAN2021 C4591001 1044 10441366 15 Male 176.5 57.8 18.6 White Non-Hispanic/non- Latino11JAN2021 C4591001 1044 10441367# 12 Male 154.9 92 38.3 White Non-Hispanic/non- Latino11JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 63 FDA-CBER-2022-5812-0223436 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1044 10441368 15 Female 162.6 56.2 21.3 White Non-Hispanic/non- Latino11JAN2021 C4591001 1044 10441369# 12 Male 154.9 80.6 33.6 White Non-Hispanic/non- Latino11JAN2021 C4591001 1044 10441370 15 Male 175.3 54.2 17.6 White Non-Hispanic/non- Latino11JAN2021 C4591001 1044 10441371 15 Female 160 55 21.5 White Non-Hispanic/non- Latino11JAN2021 C4591001 1044 10441372 13 Male 167.6 65.1 23.2 White Non-Hispanic/non- Latino11JAN2021 C4591001 1044 10441373 14 Female 156.2 43.9 18 White Non-Hispanic/non- Latino12JAN2021 C4591001 1044 10441374 15 Male 174 53.4 17.6 White Hispanic/Latino 12JAN2021 C4591001 1044 10441375 13 Female 154.9 44.2 18.4 White Non-Hispanic/non- Latino12JAN2021 C4591001 1044 10441376 15 Male 162.6 47.4 17.9 White Non-Hispanic/non- Latino12JAN2021 C4591001 1044 10441377 12 Female 165.1 49.9 18.3 White Non-Hispanic/non- Latino12JAN2021 C4591001 1044 10441378 12 Female 152.4 40.5 17.4 White Non-Hispanic/non- Latino12JAN2021 C4591001 1044 10441379 15 Male 168.9 54.5 19.1 White Non-Hispanic/non- Latino12JAN2021 C4591001 1044 10441380 13 Male 165.1 44.2 16.2 White Non-Hispanic/non- Latino12JAN2021 C4591001 1044 10441381 12 Male 167.6 42.9 15.3 White Non-Hispanic/non- Latino12JAN2021 C4591001 1044 10441382 13 Female 160 51.6 20.2 White Non-Hispanic/non- Latino12JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 64 FDA-CBER-2022-5812-0223437 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1044 10441383 14 Male 175.3 61.3 19.9 White Non-Hispanic/non- Latino12JAN2021 C4591001 1044 10441384# 13 Male 174 96.8 32 White Non-Hispanic/non- Latino12JAN2021 C4591001 1057 10571376 13 Male 167.2 55.2 19.7 White Non-Hispanic/non- Latino07DEC2020 C4591001 1057 10571377 13 Female 159.2 49.8 19.6 White Non-Hispanic/non- Latino07DEC2020 C4591001 1057 10571378# 12 Female 161.3 85.8 33 White Non-Hispanic/non- Latino07DEC2020 C4591001 1057 10571379 14 Female 163.5 63.5 23.8 Asian Non-Hispanic/non- Latino07DEC2020 C4591001 1057 10571380 13 Female 157.1 43 17.4 White Non-Hispanic/non- Latino08DEC2020 C4591001 1057 10571382 13 Female 151.7 52.6 22.9 Black or African American Non-Hispanic/non- Latino08DEC2020 C4591001 1057 10571383 14 Female 160.5 59.5 23.1 White Non-Hispanic/non- Latino08DEC2020 C4591001 1057 10571384 15 Male 155.2 44 18.3 White Non-Hispanic/non- Latino08DEC2020 C4591001 1057 10571385 15 Female 174.5 61.5 20.2 White Non-Hispanic/non- Latino08DEC2020 C4591001 1057 10571386# 14 Male 171.5 115.8 39.4 Black or African American Non-Hispanic/non- Latino08DEC2020 C4591001 1057 10571387 14 Female 158.2 59.9 23.9 White Non-Hispanic/non- Latino09DEC2020 C4591001 1057 10571388 14 Male 166 45 16.3 White Non-Hispanic/non- Latino09DEC2020 C4591001 1057 10571389 12 Female 165.5 48.5 17.7 White Non-Hispanic/non- Latino09DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 65 FDA-CBER-2022-5812-0223438 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1057 10571390 15 Male 173 79.5 26.6 White Non-Hispanic/non- Latino09DEC2020 C4591001 1057 10571391 15 Male 178.3 66 20.8 White Non-Hispanic/non- Latino09DEC2020 C4591001 1057 10571392 15 Female 165.8 55.9 20.3 White Non-Hispanic/non- Latino09DEC2020 C4591001 1057 10571393 15 Female 161.5 42 16.1 White Non-Hispanic/non- Latino09DEC2020 C4591001 1057 10571394 15 Female 155.6 64.5 26.6 White Non-Hispanic/non- Latino09DEC2020 C4591001 1057 10571395 13 Female 163 71.2 26.8 Black or African American Non-Hispanic/non- Latino09DEC2020 C4591001 1057 10571396 13 Male 161 44 17 Black or African American Non-Hispanic/non- Latino10DEC2020 C4591001 1057 10571397 14 Female 161.5 63.2 24.2 White Non-Hispanic/non- Latino10DEC2020 C4591001 1057 10571398 14 Male 180 64 19.8 White Non-Hispanic/non- Latino10DEC2020 C4591001 1057 10571399# 12 Male 160 66.5 26 White Non-Hispanic/non- Latino10DEC2020 C4591001 1057 10571400 13 Male 168 59.5 21.1 Black or African American Non-Hispanic/non- Latino11DEC2020 C4591001 1057 10571401 13 Female 172.7 70.9 23.8 White Non-Hispanic/non- Latino11DEC2020 C4591001 1057 10571402# 15 Female 169 86 30.1 White Non-Hispanic/non- Latino14DEC2020 C4591001 1057 10571403 12 Male 154.5 41.3 17.3 White Non-Hispanic/non- Latino14DEC2020 C4591001 1057 10571404 13 Female 155.3 64 26.5 White Non-Hispanic/non- Latino16DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 66 FDA-CBER-2022-5812-0223439 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1057 10571405 15 Male 175.8 63.1 20.4 White Non-Hispanic/non- Latino16DEC2020 C4591001 1057 10571406 13 Male 166.8 55.2 19.8 White Non-Hispanic/non- Latino16DEC2020 C4591001 1057 10571407 15 Male 171.9 53.3 18 White Non-Hispanic/non- Latino17DEC2020 C4591001 1057 10571408 14 Male 176.7 58.2 18.6 White Non-Hispanic/non- Latino17DEC2020 C4591001 1057 10571409 12 Male 146.8 33.3 15.5 White Non-Hispanic/non- Latino17DEC2020 C4591001 1057 10571410 12 Male 147.8 34.2 15.7 Asian Non-Hispanic/non- Latino17DEC2020 C4591001 1057 10571411 15 Female 155.8 47 19.4 White Non-Hispanic/non- Latino17DEC2020 C4591001 1057 10571412 13 Male 165.4 54.8 20 White Non-Hispanic/non- Latino17DEC2020 C4591001 1057 10571414 15 Female 163.2 47.9 18 Multiracial Hispanic/Latino 21DEC2020 C4591001 1057 10571415 14 Female 163 42.5 16 White Non-Hispanic/non- Latino21DEC2020 C4591001 1057 10571416 14 Male 161 55.3 21.3 White Non-Hispanic/non- Latino21DEC2020 C4591001 1057 10571417# 14 Female 158 70.1 28.1 White Non-Hispanic/non- Latino21DEC2020 C4591001 1057 10571418# 14 Female 161.5 114.8 44 White Non-Hispanic/non- Latino22DEC2020 C4591001 1057 10571419 14 Male 173.8 67 22.2 White Non-Hispanic/non- Latino22DEC2020 C4591001 1057 10571420 14 Male 171.2 56.5 19.3 White Non-Hispanic/non- Latino23DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 67 FDA-CBER-2022-5812-0223440 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1057 10571421# 15 Male 166.7 111.5 40.1 Black or African American Non-Hispanic/non- Latino23DEC2020 C4591001 1057 10571422# 14 Male 175 119 38.9 White Non-Hispanic/non- Latino23DEC2020 C4591001 1057 10571423 15 Male 175.2 78.3 25.5 Black or African American Hispanic/Latino 24DEC2020 C4591001 1057 10571424# 12 Male 172.6 80 26.9 Black or African American Hispanic/Latino 24DEC2020 C4591001 1057 10571425 13 Female 157.8 41 16.5 White Non-Hispanic/non- Latino24DEC2020 C4591001 1057 10571426 12 Female 148 36.6 16.7 White Hispanic/Latino 24DEC2020 C4591001 1057 10571427 12 Female 148.5 31.6 14.3 White Hispanic/Latino 24DEC2020 C4591001 1057 10571428 14 Male 154.5 37.8 15.8 White Hispanic/Latino 24DEC2020 C4591001 1057 10571429 15 Female 162.9 56.2 21.2 White Hispanic/Latino 24DEC2020 C4591001 1057 10571430# 12 Female 172.6 104.3 35 Black or African American Non-Hispanic/non- Latino29DEC2020 C4591001 1057 10571431 13 Male 161 49.3 19 White Non-Hispanic/non- Latino30DEC2020 C4591001 1057 10571432 12 Female 155.1 33.1 13.8 White Non-Hispanic/non- Latino30DEC2020 C4591001 1057 10571433 12 Female 166 67.5 24.5 Black or African American Non-Hispanic/non- Latino30DEC2020 C4591001 1057 10571434# 13 Male 159 92.5 36.6 Multiracial Non-Hispanic/non- Latino31DEC2020 C4591001 1057 10571435# 12 Male 156.2 69.3 28.4 Black or African American Hispanic/Latino 04JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 68 FDA-CBER-2022-5812-0223441 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1057 10571436 14 Female 165 60 22 Black or African American Hispanic/Latino 04JAN2021 C4591001 1057 10571437 15 Male 173.5 64.5 21.4 White Non-Hispanic/non- Latino04JAN2021 C4591001 1057 10571438 13 Female 172.3 71.6 24.1 White Non-Hispanic/non- Latino04JAN2021 C4591001 1057 10571439 14 Female 163.4 48.1 18 White Non-Hispanic/non- Latino06JAN2021 C4591001 1057 10571440 12 Male 166.5 47.7 17.2 White Non-Hispanic/non- Latino06JAN2021 C4591001 1057 10571441 13 Male 162.2 51.7 19.7 Asian Non-Hispanic/non- Latino06JAN2021 C4591001 1057 10571442 13 Male 168 62.3 22.1 Black or African American Non-Hispanic/non- Latino07JAN2021 C4591001 1057 10571443 12 Female 169.6 68 23.6 White Non-Hispanic/non- Latino08JAN2021 C4591001 1057 10571444 14 Female 168.6 58.2 20.5 White Non-Hispanic/non- Latino08JAN2021 C4591001 1057 10571445 15 Male 183.5 88.2 26.2 White Non-Hispanic/non- Latino11JAN2021 C4591001 1057 10571446 13 Female 168.4 55.1 19.4 White Non-Hispanic/non- Latino11JAN2021 C4591001 1057 10571447# 15 Male 189.5 115.3 32.1 White Non-Hispanic/non- Latino11JAN2021 C4591001 1057 10571448 13 Female 167 67 24 White Non-Hispanic/non- Latino11JAN2021 C4591001 1057 10571449 12 Male 169.5 37 12.9 White Non-Hispanic/non- Latino12JAN2021 C4591001 1057 10571450 13 Male 176 62.7 20.2 White Non-Hispanic/non- Latino12JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 69 FDA-CBER-2022-5812-0223442 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1057 10571451 12 Female 177.4 55.1 17.5 White Non-Hispanic/non- Latino12JAN2021 C4591001 1057 10571452 12 Female 168.5 63.5 22.4 White Non-Hispanic/non- Latino12JAN2021 C4591001 1057 10571453 13 Male 169.5 57.6 20 White Non-Hispanic/non- Latino12JAN2021 C4591001 1057 10571454 13 Female 160 46.4 18.1 White Non-Hispanic/non- Latino12JAN2021 C4591001 1066 10661394 14 Male 168.91 58.27 20.4 White Non-Hispanic/non- Latino01DEC2020 C4591001 1066 10661395# 12 Male 161.29 101.09 38.8 White Non-Hispanic/non- Latino01DEC2020 C4591001 1066 10661397 14 Male 180.34 60.64 18.6 White Non-Hispanic/non- Latino01DEC2020 C4591001 1066 10661401 14 Male 172.72 57.86 19.4 White Non-Hispanic/non- Latino02DEC2020 C4591001 1066 10661402 14 Female 162.56 54.36 20.5 White Non-Hispanic/non- Latino02DEC2020 C4591001 1066 10661403 14 Male 158.75 53.27 21.1 White Non-Hispanic/non- Latino03DEC2020 C4591001 1066 10661404 12 Female 160.02 58.5 22.8 White Non-Hispanic/non- Latino03DEC2020 C4591001 1066 10661405 13 Male 157.48 40.09 16.1 White Non-Hispanic/non- Latino03DEC2020 C4591001 1066 10661407 15 Female 177.8 62.27 19.7 White Non-Hispanic/non- Latino04DEC2020 C4591001 1066 10661408 15 Female 175.9 65.32 21.1 White Non-Hispanic/non- Latino08DEC2020 C4591001 1066 10661409 12 Male 148.59 33.73 15.2 White Non-Hispanic/non- Latino08DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 70 FDA-CBER-2022-5812-0223443 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1066 10661410 13 Female 162.56 60.09 22.7 White Non-Hispanic/non- Latino09DEC2020 C4591001 1066 10661411 15 Male 168.91 65.64 23 White Non-Hispanic/non- Latino09DEC2020 C4591001 1066 10661412 14 Female 154.94 56.41 23.4 White Non-Hispanic/non- Latino09DEC2020 C4591001 1066 10661414# 15 Male 160.02 76.45 29.8 White Hispanic/Latino 14DEC2020 C4591001 1066 10661415# 14 Female 165.1 93.45 34.2 White Hispanic/Latino 14DEC2020 C4591001 1066 10661416 12 Male 151.13 37.09 16.2 White Non-Hispanic/non- Latino15DEC2020 C4591001 1066 10661417 12 Male 149.86 43.18 19.2 White Non-Hispanic/non- Latino16DEC2020 C4591001 1066 10661418 14 Male 187.96 77.73 22 White Non-Hispanic/non- Latino16DEC2020 C4591001 1066 10661419 14 Female 157.48 42.27 17 Multiracial Non-Hispanic/non- Latino16DEC2020 C4591001 1066 10661420 15 Female 172.72 61.45 20.6 White Hispanic/Latino 17DEC2020 C4591001 1066 10661421 14 Male 160.02 53.27 20.8 White Non-Hispanic/non- Latino22DEC2020 C4591001 1066 10661422 12 Male 160.02 53.05 20.7 White Non-Hispanic/non- Latino22DEC2020 C4591001 1066 10661423# 14 Male 179.71 87.55 27 White Hispanic/Latino 30DEC2020 C4591001 1066 10661424 14 Male 166.37 52.73 19 Native Hawaiian or other Pacific Islande rHispanic/Latino 30DEC2020 C4591001 1066 10661425 14 Female 163.2 53.18 19.9 White Non-Hispanic/non- Latino05JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 71 FDA-CBER-2022-5812-0223444 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1066 10661426 15 Male 173.99 54 17.8 Multiracial Non-Hispanic/non- Latino06JAN2021 C4591001 1066 10661427 15 Male 180.34 64.36 19.7 White Non-Hispanic/non- Latino06JAN2021 C4591001 1066 10661428 15 Female 165.1 59.14 21.6 Black or African American Non-Hispanic/non- Latino06JAN2021 C4591001 1066 10661429 12 Male 154.94 52.73 21.9 White Non-Hispanic/non- Latino06JAN2021 C4591001 1066 10661430# 13 Male 173.99 91.73 30.2 White Non-Hispanic/non- Latino07JAN2021 C4591001 1066 10661431 15 Female 175.26 74.73 24.3 White Non-Hispanic/non- Latino07JAN2021 C4591001 1066 10661432 14 Female 161.93 58.27 22.2 White Non-Hispanic/non- Latino07JAN2021 C4591001 1066 10661433 12 Female 152.4 56.59 24.3 White Non-Hispanic/non- Latino07JAN2021 C4591001 1066 10661434 15 Male 165.1 53.18 19.5 White Non-Hispanic/non- Latino12JAN2021 C4591001 1066 10661435 13 Female 157.48 42.64 17.2 White Non-Hispanic/non- Latino12JAN2021 C4591001 1077 10771274 14 Female 163.83 63.64 23.7 White Non-Hispanic/non- Latino03DEC2020 C4591001 1077 10771275 13 Male 160.02 41.45 16.2 White Non-Hispanic/non- Latino03DEC2020 C4591001 1077 10771277 13 Male 158.75 39.64 15.7 White Non-Hispanic/non- Latino04DEC2020 C4591001 1077 10771278 13 Male 165.1 47.09 17.2 White Non-Hispanic/non- Latino04DEC2020 C4591001 1077 10771279 13 Male 163.07 48.73 18.3 White Non-Hispanic/non- Latino14DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 72 FDA-CBER-2022-5812-0223445 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1077 10771280 14 Female 163.83 50.36 18.7 White Non-Hispanic/non- Latino14DEC2020 C4591001 1077 10771281 14 Male 168 70.8 25.1 White Non-Hispanic/non- Latino14DEC2020 C4591001 1077 10771282 14 Male 180.34 67.09 20.6 White Non-Hispanic/non- Latino14DEC2020 C4591001 1077 10771283 13 Male 167 62.7 22.5 White Non-Hispanic/non- Latino15DEC2020 C4591001 1077 10771284 15 Male 187 78.7 22.5 White Non-Hispanic/non- Latino15DEC2020 C4591001 1077 10771285 14 Female 160.02 57.55 22.4 White Non-Hispanic/non- Latino15DEC2020 C4591001 1077 10771286 14 Female 170 62.8 21.7 White Non-Hispanic/non- Latino15DEC2020 C4591001 1077 10771287 15 Male 172.72 60.45 20.2 White Non-Hispanic/non- Latino15DEC2020 C4591001 1077 10771288 15 Male 180.34 72.73 22.3 Black or African American Non-Hispanic/non- Latino16DEC2020 C4591001 1077 10771289 14 Female 175.26 54.09 17.6 White Non-Hispanic/non- Latino18DEC2020 C4591001 1077 10771290 14 Female 170.18 58.91 20.3 White Non-Hispanic/non- Latino18DEC2020 C4591001 1077 10771291 15 Male 167.64 55.36 19.7 White Non-Hispanic/non- Latino18DEC2020 C4591001 1077 10771292 14 Male 167.64 48.55 17.2 White Non-Hispanic/non- Latino18DEC2020 C4591001 1077 10771294 14 Male 167 48.9 17.5 White Non-Hispanic/non- Latino28DEC2020 C4591001 1077 10771295 15 Male 172.5 70 23.5 White Non-Hispanic/non- Latino28DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 73 FDA-CBER-2022-5812-0223446 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1077 10771296 13 Male 161 42.2 16.3 White Non-Hispanic/non- Latino29DEC2020 C4591001 1077 10771297# 12 Female 148 57.7 26.3 White Non-Hispanic/non- Latino06JAN2021 C4591001 1077 10771298 14 Male 166.37 50.36 18.2 White Non-Hispanic/non- Latino07JAN2021 C4591001 1077 10771299 13 Male 150.5 34.4 15.2 White Non-Hispanic/non- Latino07JAN2021 C4591001 1077 10771300 15 Female 158 62.4 25 White Non-Hispanic/non- Latino07JAN2021 C4591001 1084 10841541# 14 Male 174 84.7 28 White Non-Hispanic/non- Latino11DEC2020 C4591001 1084 10841542 15 Female 149 54.3 24.5 Asian Non-Hispanic/non- Latino11DEC2020 C4591001 1084 10841543 12 Male 160 45 17.6 White Non-Hispanic/non- Latino18DEC2020 C4591001 1084 10841544 15 Male 175.3 59.4 19.3 White Non-Hispanic/non- Latino18DEC2020 C4591001 1084 10841545 12 Female 158 51.5 20.6 White Non-Hispanic/non- Latino18DEC2020 C4591001 1084 10841546 14 Female 158 41.2 16.5 White Non-Hispanic/non- Latino18DEC2020 C4591001 1084 10841547# 15 Male 171 92.3 31.6 White Hispanic/Latino 21DEC2020 C4591001 1084 10841548 13 Female 159.5 53.9 21.2 White Non-Hispanic/non- Latino21DEC2020 C4591001 1084 10841549# 14 Male 171 78 26.7 White Hispanic/Latino 21DEC2020 C4591001 1084 10841550 15 Male 167 54.1 19.4 White Non-Hispanic/non- Latino21DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 74 FDA-CBER-2022-5812-0223447 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1084 10841551 13 Male 158 48.4 19.4 White Non-Hispanic/non- Latino21DEC2020 C4591001 1084 10841552 13 Male 164.5 48.1 17.8 White Non-Hispanic/non- Latino21DEC2020 C4591001 1084 10841553 15 Male 166.7 60.5 21.8 White Non-Hispanic/non- Latino21DEC2020 C4591001 1084 10841555 13 Male 176.9 67.8 21.7 White Non-Hispanic/non- Latino21DEC2020 C4591001 1084 10841556 15 Female 167.5 75.5 26.9 White Non-Hispanic/non- Latino28DEC2020 C4591001 1084 10841557# 13 Female 160 88.8 34.7 White Non-Hispanic/non- Latino28DEC2020 C4591001 1084 10841558# 15 Female 164 124.1 46.1 White Non-Hispanic/non- Latino28DEC2020 C4591001 1084 10841559# 13 Male 159 98.2 38.8 White Non-Hispanic/non- Latino28DEC2020 C4591001 1084 10841560 15 Male 177.9 58.6 18.5 White Hispanic/Latino 28DEC2020 C4591001 1084 10841561 15 Female 168 69.9 24.8 White Non-Hispanic/non- Latino28DEC2020 C4591001 1084 10841562 12 Male 170 65.2 22.6 White Non-Hispanic/non- Latino28DEC2020 C4591001 1084 10841563 13 Female 152 42.5 18.4 White Hispanic/Latino 30DEC2020 C4591001 1084 10841564 12 Male 153 53.1 22.7 White Hispanic/Latino 30DEC2020 C4591001 1084 10841565 14 Female 157 52 21.1 White Non-Hispanic/non- Latino30DEC2020 C4591001 1084 10841566 15 Male 175 69.5 22.7 Asian Non-Hispanic/non- Latino30DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 75 FDA-CBER-2022-5812-0223448 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1084 10841567 14 Female 168.5 54.3 19.1 Asian Non-Hispanic/non- Latino30DEC2020 C4591001 1084 10841568 15 Male 181.5 78.6 23.9 White Hispanic/Latino 30DEC2020 C4591001 1084 10841569 14 Female 161 48.8 18.8 White Hispanic/Latino 30DEC2020 C4591001 1084 10841570 13 Male 172.6 44.9 15.1 White Hispanic/Latino 30DEC2020 C4591001 1084 10841571 15 Female 164.2 58.3 21.6 Asian Non-Hispanic/non- Latino30DEC2020 C4591001 1084 10841572 13 Female 161.6 56.1 21.5 White Hispanic/Latino 04JAN2021 C4591001 1084 10841573 12 Female 150.6 58 25.6 White Hispanic/Latino 04JAN2021 C4591001 1084 10841574# 12 Male 160.4 73.6 28.6 White Hispanic/Latino 04JAN2021 C4591001 1084 10841575 15 Male 168.5 46 16.2 Asian Hispanic/Latino 04JAN2021 C4591001 1084 10841576 15 Male 173 62.5 20.9 White Non-Hispanic/non- Latino06JAN2021 C4591001 1084 10841577 15 Female 159 60 23.7 White Non-Hispanic/non- Latino06JAN2021 C4591001 1084 10841578 13 Male 150 42.1 18.7 White Non-Hispanic/non- Latino06JAN2021 C4591001 1084 10841579 13 Female 161 59.2 22.8 White Non-Hispanic/non- Latino06JAN2021 C4591001 1084 10841580 12 Female 160 53.5 20.9 White Non-Hispanic/non- Latino06JAN2021 C4591001 1084 10841581 14 Male 175 63.4 20.7 White Non-Hispanic/non- Latino06JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 76 FDA-CBER-2022-5812-0223449 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1084 10841582 12 Male 154 42 17.7 Asian Hispanic/Latino 06JAN2021 C4591001 1084 10841583# 15 Female 162.5 77.7 29.4 White Non-Hispanic/non- Latino08JAN2021 C4591001 1084 10841584# 14 Female 158.9 71.2 28.2 White Hispanic/Latino 08JAN2021 C4591001 1084 10841586# 15 Male 182 112.3 33.9 White Hispanic/Latino 08JAN2021 C4591001 1084 10841587 12 Male 147.6 31.6 14.5 White Non-Hispanic/non- Latino08JAN2021 C4591001 1084 10841588# 14 Female 153.9 80.6 34 White Hispanic/Latino 08JAN2021 C4591001 1084 10841589# 15 Male 169.5 95.6 33.3 White Hispanic/Latino 08JAN2021 C4591001 1084 10841590 15 Male 172 58.8 19.9 White Non-Hispanic/non- Latino08JAN2021 C4591001 1084 10841591 12 Female 161 46.7 18 White Non-Hispanic/non- Latino08JAN2021 C4591001 1084 10841592 14 Female 161 42.2 16.3 Asian Non-Hispanic/non- Latino08JAN2021 C4591001 1084 10841593 12 Male 158.3 45.6 18.2 White Non-Hispanic/non- Latino08JAN2021 C4591001 1084 10841594 12 Male 169.1 52.8 18.5 White Non-Hispanic/non- Latino08JAN2021 C4591001 1084 10841595 13 Female 152 56.4 24.4 White Hispanic/Latino 08JAN2021 C4591001 1084 10841596 14 Female 159.1 50.5 20 White Hispanic/Latino 08JAN2021 C4591001 1084 10841597# 15 Male 170.6 79.95 27.5 White Hispanic/Latino 08JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 77 FDA-CBER-2022-5812-0223450 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1091 10911394 15 Female 174 69.5 23 White Non-Hispanic/non- Latino02DEC2020 C4591001 1091 10911395 14 Male 171.5 51.5 17.5 White Non-Hispanic/non- Latino02DEC2020 C4591001 1091 10911396 15 Female 154.9 50.6 21.1 White Non-Hispanic/non- Latino02DEC2020 C4591001 1091 10911399 14 Male 182.6 60.5 18.1 White Non-Hispanic/non- Latino04DEC2020 C4591001 1091 10911400 14 Female 152.6 61.1 26.2 White Non-Hispanic/non- Latino04DEC2020 C4591001 1091 10911402 12 Female 153.7 48.1 20.4 White Non-Hispanic/non- Latino07DEC2020 C4591001 1091 10911403 15 Male 166.4 48.2 17.4 Black or African American Non-Hispanic/non- Latino07DEC2020 C4591001 1091 10911404# 13 Female 175.3 86.9 28.3 White Non-Hispanic/non- Latino07DEC2020 C4591001 1091 10911405 12 Male 157.5 56.7 22.9 White Non-Hispanic/non- Latino07DEC2020 C4591001 1091 10911406 14 Male 157.5 46.1 18.6 White Non-Hispanic/non- Latino07DEC2020 C4591001 1091 10911407 12 Male 160.5 45.4 17.6 White Non-Hispanic/non- Latino08DEC2020 C4591001 1091 10911408 15 Male 174 69.2 22.9 White Non-Hispanic/non- Latino08DEC2020 C4591001 1091 10911409 14 Female 154.2 43.9 18.5 Asian Non-Hispanic/non- Latino09DEC2020 C4591001 1091 10911410 12 Female 150.9 39.4 17.3 White Non-Hispanic/non- Latino09DEC2020 C4591001 1091 10911411 15 Male 173.2 54.2 18.1 White Non-Hispanic/non- Latino09DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 78 FDA-CBER-2022-5812-0223451 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1091 10911412# 15 Female 162.6 79 29.9 Multiracial Non-Hispanic/non- Latino09DEC2020 C4591001 1091 10911413 12 Male 160.7 57.1 22.1 White Non-Hispanic/non- Latino09DEC2020 C4591001 1091 10911414# 14 Male 162.3 71.9 27.3 White Non-Hispanic/non- Latino09DEC2020 C4591001 1091 10911415 15 Female 158.8 52.4 20.8 Asian Non-Hispanic/non- Latino10DEC2020 C4591001 1091 10911416 15 Male 176.5 60.1 19.3 White Non-Hispanic/non- Latino10DEC2020 C4591001 1091 10911417 13 Female 172.7 59.5 19.9 White Non-Hispanic/non- Latino10DEC2020 C4591001 1091 10911418 14 Male 160.7 48.6 18.8 White Non-Hispanic/non- Latino10DEC2020 C4591001 1091 10911419 13 Female 161.3 39.9 15.3 White Non-Hispanic/non- Latino10DEC2020 C4591001 1091 10911420 12 Female 130.2 41.7 24.6 White Hispanic/Latino 10DEC2020 C4591001 1091 10911421 15 Male 167 52.2 18.7 White Non-Hispanic/non- Latino10DEC2020 C4591001 1091 10911422 15 Female 168.9 55.2 19.3 White Non-Hispanic/non- Latino14DEC2020 C4591001 1091 10911423 14 Female 158.8 48.5 19.2 Black or African American Non-Hispanic/non- Latino14DEC2020 C4591001 1091 10911424 14 Male 179.1 62.5 19.5 White Non-Hispanic/non- Latino15DEC2020 C4591001 1091 10911425 12 Female 157.5 53.6 21.6 White Non-Hispanic/non- Latino15DEC2020 C4591001 1091 10911426 13 Female 167.6 50.6 18 White Non-Hispanic/non- Latino16DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 79 FDA-CBER-2022-5812-0223452 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1091 10911427 12 Male 149.6 36.6 16.4 White Non-Hispanic/non- Latino16DEC2020 C4591001 1091 10911428 13 Female 152.7 43 18.4 White Non-Hispanic/non- Latino16DEC2020 C4591001 1091 10911429 15 Male 177.8 74 23.4 White Non-Hispanic/non- Latino16DEC2020 C4591001 1091 10911430 13 Female 156.2 44 18 White Non-Hispanic/non- Latino16DEC2020 C4591001 1091 10911431# 13 Male 165.1 71.3 26.2 White Non-Hispanic/non- Latino17DEC2020 C4591001 1091 10911432 12 Female 144.8 32.4 15.5 White Non-Hispanic/non- Latino17DEC2020 C4591001 1091 10911433 14 Male 173.2 57.2 19.1 White Hispanic/Latino 17DEC2020 C4591001 1091 10911434 14 Male 160 44.9 17.5 Black or African American Non-Hispanic/non- Latino17DEC2020 C4591001 1091 10911435 12 Male 163.8 46.1 17.2 White Non-Hispanic/non- Latino17DEC2020 C4591001 1091 10911436 14 Male 175.3 53.8 17.5 White Non-Hispanic/non- Latino17DEC2020 C4591001 1091 10911437 13 Male 174 47.5 15.7 White Non-Hispanic/non- Latino17DEC2020 C4591001 1091 10911438 12 Male 160 51.2 20 Asian Non-Hispanic/non- Latino18DEC2020 C4591001 1091 10911439 14 Male 161.3 50 19.2 White Non-Hispanic/non- Latino18DEC2020 C4591001 1091 10911440 13 Female 160 40.6 15.9 White Non-Hispanic/non- Latino18DEC2020 C4591001 1091 10911441 13 Female 158.1 36.6 14.6 White Non-Hispanic/non- Latino18DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 80 FDA-CBER-2022-5812-0223453 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1091 10911442 15 Female 175.3 71.6 23.3 White Non-Hispanic/non- Latino18DEC2020 C4591001 1091 10911443 12 Male 154.9 51.1 21.3 Asian Non-Hispanic/non- Latino21DEC2020 C4591001 1091 10911444 15 Male 180.3 68 20.9 White Non-Hispanic/non- Latino21DEC2020 C4591001 1091 10911445 13 Male 182.9 62 18.5 Asian Non-Hispanic/non- Latino21DEC2020 C4591001 1091 10911446# 12 Male 161.3 66.8 25.7 White Non-Hispanic/non- Latino22DEC2020 C4591001 1091 10911447 15 Male 158.8 48.1 19.1 White Non-Hispanic/non- Latino22DEC2020 C4591001 1091 10911448 13 Male 156.2 39 16 White Non-Hispanic/non- Latino22DEC2020 C4591001 1091 10911449 13 Male 172.7 56.8 19 White Non-Hispanic/non- Latino22DEC2020 C4591001 1091 10911450 13 Male 160 51.9 20.3 Multiracial Non-Hispanic/non- Latino22DEC2020 C4591001 1091 10911452 14 Female 174 76.7 25.3 White Non-Hispanic/non- Latino22DEC2020 C4591001 1091 10911453 15 Female 153.7 54.6 23.1 Asian Non-Hispanic/non- Latino22DEC2020 C4591001 1091 10911454 14 Male 181.6 62.6 19 Multiracial Non-Hispanic/non- Latino28DEC2020 C4591001 1091 10911455 12 Female 159.3 52.1 20.5 White Non-Hispanic/non- Latino29DEC2020 C4591001 1091 10911456# 13 Female 160 69.5 27.1 White Non-Hispanic/non- Latino29DEC2020 C4591001 1091 10911457 13 Female 158.8 61 24.2 White Non-Hispanic/non- Latino29DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 81 FDA-CBER-2022-5812-0223454 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1091 10911458 14 Male 165.1 50.2 18.4 White Non-Hispanic/non- Latino29DEC2020 C4591001 1091 10911459 14 Male 165.1 50.9 18.7 White Non-Hispanic/non- Latino29DEC2020 C4591001 1091 10911460 13 Female 164.3 54 20 Black or African American Non-Hispanic/non- Latino30DEC2020 C4591001 1091 10911461 14 Female 149.9 54 24 Asian Non-Hispanic/non- Latino30DEC2020 C4591001 1091 10911462# 15 Male 179.1 95.3 29.7 White Non-Hispanic/non- Latino04JAN2021 C4591001 1091 10911463 15 Male 182.9 64.7 19.3 White Non-Hispanic/non- Latino04JAN2021 C4591001 1091 10911464 13 Female 167.6 48 17.1 White Non-Hispanic/non- Latino04JAN2021 C4591001 1091 10911465 15 Female 164.6 45.9 16.9 White Non-Hispanic/non- Latino05JAN2021 C4591001 1091 10911466 13 Male 168.9 62.9 22 White Non-Hispanic/non- Latino11JAN2021 C4591001 1123 11231422 15 Male 187 80.3 23 White Non-Hispanic/non- Latino01DEC2020 C4591001 1123 11231425# 14 Female 167 88.4 31.7 White Non-Hispanic/non- Latino02DEC2020 C4591001 1123 11231428 12 Male 154 40.5 17.1 White Non-Hispanic/non- Latino03DEC2020 C4591001 1123 11231431 13 Male 165 51 18.7 White Non-Hispanic/non- Latino04DEC2020 C4591001 1123 11231432 14 Male 170 63.3 21.9 White Non-Hispanic/non- Latino04DEC2020 C4591001 1123 11231434 12 Female 160 55.2 21.6 White Hispanic/Latino 07DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 82 FDA-CBER-2022-5812-0223455 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1123 11231438 14 Female 162.5 59.1 22.4 American Indian or Alaska Native Hispanic/Latino 08DEC2020 C4591001 1123 11231439# 12 Female 166 101 36.7 American Indian or Alaska Native Hispanic/Latino 08DEC2020 C4591001 1123 11231440# 13 Male 171.5 79.5 27 White Non-Hispanic/non- Latino09DEC2020 C4591001 1123 11231441# 14 Male 170 77.4 26.8 Black or African American Hispanic/Latino 09DEC2020 C4591001 1123 11231442# 12 Male 164 86.5 32.2 White Non-Hispanic/non- Latino09DEC2020 C4591001 1123 11231443 14 Female 163 61.1 23 White Non-Hispanic/non- Latino09DEC2020 C4591001 1123 11231445 12 Female 147 36.7 17 White Non-Hispanic/non- Latino09DEC2020 C4591001 1123 11231446 14 Male 174.5 56 18.4 White Non-Hispanic/non- Latino09DEC2020 C4591001 1123 11231447 13 Male 149 43.6 19.6 White Non-Hispanic/non- Latino10DEC2020 C4591001 1123 11231448# 13 Male 170 117 40.5 Black or African American Non-Hispanic/non- Latino11DEC2020 C4591001 1123 11231449# 15 Female 135.2 64 35 White Non-Hispanic/non- Latino11DEC2020 C4591001 1123 11231450 15 Male 179 68.5 21.4 Black or African American Non-Hispanic/non- Latino11DEC2020 C4591001 1123 11231451# 12 Male 164.1 68.9 25.6 White Non-Hispanic/non- Latino15DEC2020 C4591001 1123 11231452 15 Female 164 58.5 21.8 White Non-Hispanic/non- Latino15DEC2020 C4591001 1123 11231453# 12 Male 167 69.2 24.8 White Non-Hispanic/non- Latino15DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 83 FDA-CBER-2022-5812-0223456 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1123 11231454 15 Female 171 50.8 17.4 White Non-Hispanic/non- Latino15DEC2020 C4591001 1123 11231455 13 Female 166.5 61.7 22.3 White Non-Hispanic/non- Latino15DEC2020 C4591001 1123 11231456 13 Female 158.1 58.1 23.2 White Non-Hispanic/non- Latino16DEC2020 C4591001 1123 11231457 15 Female 158.5 38.6 15.4 White Non-Hispanic/non- Latino16DEC2020 C4591001 1123 11231458 12 Female 161 62.9 24.3 White Hispanic/Latino 16DEC2020 C4591001 1123 11231459 15 Female 165 75.4 27.7 White Non-Hispanic/non- Latino16DEC2020 C4591001 1123 11231460 15 Female 164 58 21.6 White Non-Hispanic/non- Latino17DEC2020 C4591001 1123 11231461 15 Male 201 80.9 20 White Non-Hispanic/non- Latino17DEC2020 C4591001 1123 11231462 12 Male 157.5 51 20.6 White Non-Hispanic/non- Latino17DEC2020 C4591001 1123 11231463 14 Female 171 47.9 16.4 White Non-Hispanic/non- Latino18DEC2020 C4591001 1123 11231465 14 Female 165.5 51.1 18.7 White Non-Hispanic/non- Latino18DEC2020 C4591001 1123 11231466 13 Female 155 34.9 14.5 White Non-Hispanic/non- Latino18DEC2020 C4591001 1123 11231467 13 Male 159.2 51.2 20.2 White Non-Hispanic/non- Latino21DEC2020 C4591001 1123 11231468 15 Female 167.5 74.7 26.6 White Non-Hispanic/non- Latino21DEC2020 C4591001 1123 11231469 14 Female 164 64.6 24 White Non-Hispanic/non- Latino21DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 84 FDA-CBER-2022-5812-0223457 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1123 11231470 13 Female 159 60.6 24 White Non-Hispanic/non- Latino21DEC2020 C4591001 1123 11231472 15 Female 165 47.4 17.4 White Non-Hispanic/non- Latino21DEC2020 C4591001 1123 11231473 15 Female 163 54 20.3 White Non-Hispanic/non- Latino21DEC2020 C4591001 1123 11231474 12 Female 162.5 61.1 23.1 White Non-Hispanic/non- Latino21DEC2020 C4591001 1123 11231475 14 Male 174 72.5 23.9 White Non-Hispanic/non- Latino21DEC2020 C4591001 1123 11231476 13 Female 164.5 44.5 16.4 White Non-Hispanic/non- Latino21DEC2020 C4591001 1123 11231477 12 Female 148.5 39.9 18.1 White Non-Hispanic/non- Latino21DEC2020 C4591001 1123 11231478 13 Female 156.5 54.4 22.2 White Non-Hispanic/non- Latino21DEC2020 C4591001 1123 11231479 14 Female 170.5 62.2 21.4 White Non-Hispanic/non- Latino21DEC2020 C4591001 1123 11231481 15 Female 172.5 49.7 16.7 White Non-Hispanic/non- Latino21DEC2020 C4591001 1123 11231482 13 Male 162.5 51.6 19.5 White Non-Hispanic/non- Latino22DEC2020 C4591001 1123 11231483 12 Female 167 53.6 19.2 Multiracial Non-Hispanic/non- Latino22DEC2020 C4591001 1123 11231484 14 Female 158 38.8 15.5 White Non-Hispanic/non- Latino22DEC2020 C4591001 1123 11231485 13 Female 165 47 17.3 White Non-Hispanic/non- Latino22DEC2020 C4591001 1123 11231486 14 Female 163.2 53.5 20.1 White Non-Hispanic/non- Latino22DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 85 FDA-CBER-2022-5812-0223458 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1123 11231487 14 Male 170 72.7 25.2 White Non-Hispanic/non- Latino22DEC2020 C4591001 1123 11231488 12 Female 159 44.7 17.7 White Non-Hispanic/non- Latino22DEC2020 C4591001 1123 11231489 13 Male 160 43.8 17.1 White Non-Hispanic/non- Latino22DEC2020 C4591001 1123 11231491 14 Male 174.1 49.9 16.5 White Non-Hispanic/non- Latino22DEC2020 C4591001 1123 11231492# 15 Male 188 99 28 White Non-Hispanic/non- Latino23DEC2020 C4591001 1123 11231493# 14 Male 184 107.5 31.8 White Non-Hispanic/non- Latino23DEC2020 C4591001 1123 11231494 13 Female 164.5 51.1 18.9 White Non-Hispanic/non- Latino23DEC2020 C4591001 1123 11231495 15 Male 192.3 84.7 22.9 White Non-Hispanic/non- Latino23DEC2020 C4591001 1123 11231496 13 Female 166.2 46.6 16.9 White Non-Hispanic/non- Latino23DEC2020 C4591001 1123 11231497 13 Male 180 76.1 23.5 White Non-Hispanic/non- Latino23DEC2020 C4591001 1123 11231499 12 Male 165.5 59.2 21.6 White Non-Hispanic/non- Latino28DEC2020 C4591001 1123 11231500 14 Male 177.6 65.6 20.8 White Non-Hispanic/non- Latino28DEC2020 C4591001 1123 11231501 12 Female 167 67.1 24.1 White Non-Hispanic/non- Latino28DEC2020 C4591001 1123 11231502 14 Female 176 59.9 19.3 White Non-Hispanic/non- Latino28DEC2020 C4591001 1123 11231503 13 Female 155 38.2 15.9 White Non-Hispanic/non- Latino28DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 86 FDA-CBER-2022-5812-0223459 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1123 11231504 15 Male 178 62.7 19.8 White Non-Hispanic/non- Latino28DEC2020 C4591001 1123 11231505 12 Female 164.5 49.9 18.4 White Non-Hispanic/non- Latino28DEC2020 C4591001 1123 11231506 12 Female 160 55.9 21.8 White Non-Hispanic/non- Latino28DEC2020 C4591001 1123 11231507 14 Female 162.5 50.7 19.2 White Non-Hispanic/non- Latino28DEC2020 C4591001 1123 11231508 13 Female 165 51.5 18.9 White Non-Hispanic/non- Latino28DEC2020 C4591001 1123 11231509 12 Female 161.5 51.4 19.7 White Non-Hispanic/non- Latino29DEC2020 C4591001 1123 11231510 13 Female 165 52 19.1 White Non-Hispanic/non- Latino29DEC2020 C4591001 1123 11231511 13 Male 170 57.1 19.8 White Non-Hispanic/non- Latino30DEC2020 C4591001 1123 11231512 13 Female 163.5 52.9 19.8 White Non-Hispanic/non- Latino30DEC2020 C4591001 1123 11231513 12 Male 156 43.7 18 White Non-Hispanic/non- Latino30DEC2020 C4591001 1123 11231514 15 Male 180 60.4 18.6 White Non-Hispanic/non- Latino30DEC2020 C4591001 1123 11231515 14 Male 171.5 56.4 19.2 White Non-Hispanic/non- Latino30DEC2020 C4591001 1123 11231516 13 Male 177 78.7 25.1 White Non-Hispanic/non- Latino30DEC2020 C4591001 1123 11231517 15 Male 177 56.5 18 White Non-Hispanic/non- Latino30DEC2020 C4591001 1123 11231518# 15 Male 185 107.1 31.3 White Non-Hispanic/non- Latino30DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 87 FDA-CBER-2022-5812-0223460 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1123 11231519# 12 Female 154.9 84.1 35.1 White Non-Hispanic/non- Latino30DEC2020 C4591001 1123 11231520 12 Male 160 38.3 15 White Non-Hispanic/non- Latino30DEC2020 C4591001 1123 11231521 12 Female 147.3 37.7 17.4 White Non-Hispanic/non- Latino30DEC2020 C4591001 1123 11231522 15 Male 162.5 40.4 15.3 White Non-Hispanic/non- Latino05JAN2021 C4591001 1123 11231523 12 Male 155 33.3 13.9 White Non-Hispanic/non- Latino05JAN2021 C4591001 1123 11231524 14 Male 178 59 18.6 White Non-Hispanic/non- Latino05JAN2021 C4591001 1123 11231525 14 Female 170 68 23.5 White Non-Hispanic/non- Latino07JAN2021 C4591001 1123 11231526# 14 Female 165 78.2 28.7 White Non-Hispanic/non- Latino08JAN2021 C4591001 1124 11241236 13 Female 160.02 63.18 24.6 Asian Non-Hispanic/non- Latino14DEC2020 C4591001 1124 11241238 13 Male 165.1 52.27 19.1 White Non-Hispanic/non- Latino14DEC2020 C4591001 1124 11241239 12 Male 165.1 36.36 13.3 White Non-Hispanic/non- Latino14DEC2020 C4591001 1124 11241240 15 Female 167.64 61.36 21.8 White Non-Hispanic/non- Latino14DEC2020 C4591001 1124 11241241 13 Male 152.4 50 21.5 White Non-Hispanic/non- Latino14DEC2020 C4591001 1124 11241242# 14 Male 177.8 97.73 30.8 White Non-Hispanic/non- Latino14DEC2020 C4591001 1124 11241243# 13 Male 165.1 94.09 34.4 White Non-Hispanic/non- Latino15DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 88 FDA-CBER-2022-5812-0223461 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1124 11241244 12 Female 152.4 42 18 White Non-Hispanic/non- Latino15DEC2020 C4591001 1124 11241245 14 Female 162.56 54.55 20.6 White Non-Hispanic/non- Latino15DEC2020 C4591001 1124 11241246 12 Female 152.4 43.64 18.7 White Non-Hispanic/non- Latino15DEC2020 C4591001 1124 11241247# 13 Male 162.56 75 28.3 White Non-Hispanic/non- Latino16DEC2020 C4591001 1124 11241248 13 Female 152.4 50 21.5 White Non-Hispanic/non- Latino16DEC2020 C4591001 1124 11241249 14 Male 162.56 43.64 16.5 White Non-Hispanic/non- Latino16DEC2020 C4591001 1124 11241250 12 Female 157.48 43.18 17.4 White Non-Hispanic/non- Latino17DEC2020 C4591001 1124 11241251 15 Female 154.94 52.73 21.9 White Non-Hispanic/non- Latino18DEC2020 C4591001 1124 11241252 13 Male 147.32 38.64 17.8 White Non-Hispanic/non- Latino18DEC2020 C4591001 1124 11241253 12 Female 160.02 40 15.6 White Non-Hispanic/non- Latino18DEC2020 C4591001 1124 11241254 14 Male 172.72 50 16.7 White Non-Hispanic/non- Latino18DEC2020 C4591001 1124 11241255 13 Female 152.4 49.55 21.3 White Non-Hispanic/non- Latino18DEC2020 C4591001 1124 11241256 12 Male 154.94 44.09 18.3 White Non-Hispanic/non- Latino21DEC2020 C4591001 1124 11241257 13 Female 149.86 37.27 16.6 White Non-Hispanic/non- Latino22DEC2020 C4591001 1124 11241258 14 Female 162.56 73 27.6 White Non-Hispanic/non- Latino23DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 89 FDA-CBER-2022-5812-0223462 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1124 11241259# 13 Female 165.1 72.09 26.4 White Non-Hispanic/non- Latino23DEC2020 C4591001 1124 11241260# 13 Male 162.56 75.09 28.4 White Non-Hispanic/non- Latino23DEC2020 C4591001 1124 11241261 13 Male 149.86 40.91 18.2 White Non-Hispanic/non- Latino23DEC2020 C4591001 1124 11241262 15 Female 175.26 61 19.8 White Non-Hispanic/non- Latino23DEC2020 C4591001 1124 11241263 13 Female 162.56 57.27 21.6 White Non-Hispanic/non- Latino29DEC2020 C4591001 1124 11241264 14 Male 154.94 42.82 17.8 White Non-Hispanic/non- Latino29DEC2020 C4591001 1124 11241265 14 Female 165.1 56.82 20.8 White Non-Hispanic/non- Latino29DEC2020 C4591001 1124 11241266 12 Male 147.32 39.09 18 White Non-Hispanic/non- Latino29DEC2020 C4591001 1124 11241267 12 Male 149.86 39.09 17.4 White Non-Hispanic/non- Latino29DEC2020 C4591001 1124 11241268 14 Female 157.48 63.64 25.6 White Non-Hispanic/non- Latino04JAN2021 C4591001 1124 11241269 15 Male 177.8 54.45 17.2 White Non-Hispanic/non- Latino04JAN2021 C4591001 1124 11241270 15 Female 154.94 54.55 22.7 White Non-Hispanic/non- Latino05JAN2021 C4591001 1124 11241271 12 Male 167.64 57.36 20.4 White Non-Hispanic/non- Latino05JAN2021 C4591001 1124 11241272 12 Male 142.24 37.27 18.4 White Non-Hispanic/non- Latino05JAN2021 C4591001 1124 11241273 12 Female 149.86 48.36 21.5 White Non-Hispanic/non- Latino06JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 90 FDA-CBER-2022-5812-0223463 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1124 11241274 15 Male 167.64 47.55 16.9 White Non-Hispanic/non- Latino06JAN2021 C4591001 1124 11241275 13 Male 161.29 41.18 15.8 White Non-Hispanic/non- Latino08JAN2021 C4591001 1125 11251241 15 Female 165.1 69.09 25.3 White Non-Hispanic/non- Latino07DEC2020 C4591001 1125 11251242 15 Female 168.9 57.1 20 White Non-Hispanic/non- Latino07DEC2020 C4591001 1125 11251244 13 Female 152.4 41.36 17.8 White Non-Hispanic/non- Latino08DEC2020 C4591001 1125 11251246# 13 Female 170.18 91.36 31.5 White Hispanic/Latino 10DEC2020 C4591001 1125 11251248 15 Male 180.34 75 23 White Non-Hispanic/non- Latino11DEC2020 C4591001 1125 11251249 14 Female 170.18 64.55 22.2 White Non-Hispanic/non- Latino11DEC2020 C4591001 1125 11251250# 12 Male 153.67 60 25.4 White Non-Hispanic/non- Latino14DEC2020 C4591001 1125 11251251 13 Female 167.6 64.8 23.1 White Non-Hispanic/non- Latino14DEC2020 C4591001 1125 11251252 13 Male 170.18 72.73 25.1 White Non-Hispanic/non- Latino16DEC2020 C4591001 1125 11251253 12 Male 162.56 47.73 18 White Non-Hispanic/non- Latino16DEC2020 C4591001 1125 11251254 13 Male 172.72 56.36 18.9 White Non-Hispanic/non- Latino28DEC2020 C4591001 1125 11251255 12 Male 156.21 55.45 22.7 White Non-Hispanic/non- Latino06JAN2021 C4591001 1126 11261229 14 Male 172.7 55.5 18.6 White Non-Hispanic/non- Latino30NOV2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 91 FDA-CBER-2022-5812-0223464 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1126 11261230 13 Male 175.3 68.4 22.3 White Non-Hispanic/non- Latino30NOV2020 C4591001 1126 11261233 14 Male 165.7 44.4 16.2 White Non-Hispanic/non- Latino01DEC2020 C4591001 1126 11261235 12 Female 155 47.7 19.9 White Non-Hispanic/non- Latino01DEC2020 C4591001 1126 11261239 15 Female 157.5 61 24.6 White Non-Hispanic/non- Latino02DEC2020 C4591001 1126 11261240 15 Male 167.6 56 19.9 White Non-Hispanic/non- Latino02DEC2020 C4591001 1126 11261241 13 Male 152.4 38.55 16.6 White Non-Hispanic/non- Latino02DEC2020 C4591001 1126 11261243# 14 Male 148.6 64 29 White Non-Hispanic/non- Latino02DEC2020 C4591001 1126 11261246 13 Male 148.6 43 19.5 White Non-Hispanic/non- Latino02DEC2020 C4591001 1126 11261249 15 Male 172.1 49 16.5 White Non-Hispanic/non- Latino02DEC2020 C4591001 1126 11261250 12 Male 146.1 31.4 14.7 White Non-Hispanic/non- Latino02DEC2020 C4591001 1126 11261253 13 Male 163.2 55.8 21 White Non-Hispanic/non- Latino03DEC2020 C4591001 1126 11261254 15 Male 175.89 53.07 17.2 White Non-Hispanic/non- Latino03DEC2020 C4591001 1126 11261255 15 Male 175.89 53.97 17.4 White Non-Hispanic/non- Latino03DEC2020 C4591001 1126 11261258 13 Female 165.1 68.03 25 Multiracial Non-Hispanic/non- Latino03DEC2020 C4591001 1126 11261262 15 Female 157.48 54.43 21.9 White Non-Hispanic/non- Latino04DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 92 FDA-CBER-2022-5812-0223465 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1126 11261263 15 Male 169 55 19.3 White Non-Hispanic/non- Latino04DEC2020 C4591001 1126 11261264 13 Female 164.46 43.86 16.2 White Non-Hispanic/non- Latino04DEC2020 C4591001 1126 11261265 14 Male 150.5 37 16.3 White Non-Hispanic/non- Latino14DEC2020 C4591001 1126 11261266 12 Female 145.4 36 17 White Non-Hispanic/non- Latino14DEC2020 C4591001 1126 11261267 13 Male 162.56 47.03 17.8 White Non-Hispanic/non- Latino14DEC2020 C4591001 1126 11261268 13 Female 140.6 33 16.7 White Non-Hispanic/non- Latino14DEC2020 C4591001 1126 11261269 15 Female 173.4 56.7 18.9 White Non-Hispanic/non- Latino14DEC2020 C4591001 1126 11261270 15 Male 182.8 57.1 17.1 White Non-Hispanic/non- Latino14DEC2020 C4591001 1126 11261271 15 Male 172.2 58.5 19.7 White Non-Hispanic/non- Latino14DEC2020 C4591001 1126 11261273 13 Female 167.6 56.6 20.1 White Non-Hispanic/non- Latino14DEC2020 C4591001 1126 11261274 15 Female 162.5 62.5 23.7 White Non-Hispanic/non- Latino15DEC2020 C4591001 1126 11261275 15 Female 159.4 59.1 23.3 White Hispanic/Latino 15DEC2020 C4591001 1126 11261276 15 Male 176.4 84.8 27.3 White Hispanic/Latino 15DEC2020 C4591001 1126 11261277 15 Female 162.5 48.2 18.3 White Non-Hispanic/non- Latino15DEC2020 C4591001 1126 11261278 15 Female 162 51.6 19.7 White Non-Hispanic/non- Latino15DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 93 FDA-CBER-2022-5812-0223466 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1126 11261279 15 Male 165.1 61 22.4 White Hispanic/Latino 16DEC2020 C4591001 1126 11261280 12 Male 135.3 31.4 17.2 White Hispanic/Latino 16DEC2020 C4591001 1126 11261281 12 Male 160 38.5 15 Asian Non-Hispanic/non- Latino16DEC2020 C4591001 1126 11261282 13 Female 158.8 40 15.9 Asian Non-Hispanic/non- Latino16DEC2020 C4591001 1126 11261283 13 Female 157.4 37.6 15.2 Asian Non-Hispanic/non- Latino16DEC2020 C4591001 1126 11261284 13 Female 163.2 52 19.5 Asian Non-Hispanic/non- Latino16DEC2020 C4591001 1126 11261285# 14 Male 170.1 83.9 29 White Hispanic/Latino 16DEC2020 C4591001 1126 11261286 13 Male 170.1 46.7 16.1 White Hispanic/Latino 16DEC2020 C4591001 1126 11261287 15 Male 182.8 68.4 20.5 White Hispanic/Latino 16DEC2020 C4591001 1126 11261288 13 Male 141.5 35 17.5 White Non-Hispanic/non- Latino16DEC2020 C4591001 1126 11261289 14 Female 160.02 64.2 25.1 White Non-Hispanic/non- Latino17DEC2020 C4591001 1126 11261290# 12 Male 149.8 60.3 26.9 Not reported Not reported 17DEC2020 C4591001 1126 11261291 13 Female 157.48 49 19.8 White Hispanic/Latino 17DEC2020 C4591001 1126 11261292 12 Female 154.9 47.1 19.6 Asian Non-Hispanic/non- Latino17DEC2020 C4591001 1126 11261293# 14 Female 164.46 95.7 35.4 White Hispanic/Latino 18DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 94 FDA-CBER-2022-5812-0223467 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1126 11261294 13 Female 154.92 62.522 26.1 White Hispanic/Latino 18DEC2020 C4591001 1126 11261295 14 Male 162.5 51.2 19.4 Asian Non-Hispanic/non- Latino18DEC2020 C4591001 1126 11261296 15 Male 177.8 66.6 21.1 White Hispanic/Latino 18DEC2020 C4591001 1126 11261297 13 Male 167 67.8 24.3 White Hispanic/Latino 18DEC2020 C4591001 1126 11261298 14 Male 160 39.9 15.6 White Non-Hispanic/non- Latino18DEC2020 C4591001 1126 11261299 14 Male 167.6 58.6 20.9 White Non-Hispanic/non- Latino21DEC2020 C4591001 1126 11261300 13 Male 173.9 59.1 19.5 Asian Non-Hispanic/non- Latino22DEC2020 C4591001 1126 11261301 15 Female 163.83 59.87 22.3 White Non-Hispanic/non- Latino22DEC2020 C4591001 1126 11261302 14 Male 162.5 51.7 19.6 White Non-Hispanic/non- Latino23DEC2020 C4591001 1126 11261303# 15 Female 167 88 31.6 White Non-Hispanic/non- Latino29DEC2020 C4591001 1126 11261304 13 Male 177.8 68 21.5 White Non-Hispanic/non- Latino29DEC2020 C4591001 1126 11261305 15 Male 177.8 66.6 21.1 White Non-Hispanic/non- Latino30DEC2020 C4591001 1126 11261306 12 Male 165.1 61.2 22.5 White Non-Hispanic/non- Latino30DEC2020 C4591001 1126 11261307 14 Female 162.5 69.3 26.2 White Non-Hispanic/non- Latino04JAN2021 C4591001 1126 11261308 12 Male 147.3 47.1 21.7 White Non-Hispanic/non- Latino04JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 95 FDA-CBER-2022-5812-0223468 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1126 11261309 12 Male 148.5 41.7 18.9 White Non-Hispanic/non- Latino04JAN2021 C4591001 1126 11261310# 15 Male 176.5 113.3 36.4 White Non-Hispanic/non- Latino05JAN2021 C4591001 1126 11261311# 13 Male 157.4 68 27.4 White Non-Hispanic/non- Latino05JAN2021 C4591001 1126 11261312 14 Female 171.4 58.5 19.9 White Hispanic/Latino 05JAN2021 C4591001 1126 11261313 15 Female 170.1 62.1 21.5 Asian Non-Hispanic/non- Latino06JAN2021 C4591001 1126 11261314 13 Male 144.78 34.3 16.4 White Non-Hispanic/non- Latino06JAN2021 C4591001 1126 11261315 13 Female 157 45.2 18.3 Asian Non-Hispanic/non- Latino06JAN2021 C4591001 1126 11261316 15 Female 180.3 60.7 18.7 White Non-Hispanic/non- Latino07JAN2021 C4591001 1126 11261317 12 Female 165.1 58.5 21.5 White Non-Hispanic/non- Latino07JAN2021 C4591001 1126 11261318 12 Female 144.7 38.1 18.2 White Hispanic/Latino 07JAN2021 C4591001 1126 11261319# 14 Male 180.3 89.3 27.5 White Non-Hispanic/non- Latino07JAN2021 C4591001 1126 11261320 12 Female 165.1 58.5 21.5 White Non-Hispanic/non- Latino07JAN2021 C4591001 1126 11261321 13 Male 137 28.6 15.2 Asian Non-Hispanic/non- Latino07JAN2021 C4591001 1126 11261322 13 Male 140 29.4 15 Asian Non-Hispanic/non- Latino07JAN2021 C4591001 1126 11261323 15 Female 170.18 59.4 20.5 Asian Non-Hispanic/non- Latino08JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 96 FDA-CBER-2022-5812-0223469 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1126 11261324 12 Male 175.2 60.3 19.6 Asian Non-Hispanic/non- Latino08JAN2021 C4591001 1126 11261325 12 Female 163.83 50.7 18.9 White Hispanic/Latino 08JAN2021 C4591001 1131 11311275 14 Female 156.4 48.1 19.7 White Non-Hispanic/non- Latino04DEC2020 C4591001 1131 11311277 14 Male 172.4 54.6 18.4 White Non-Hispanic/non- Latino08DEC2020 C4591001 1131 11311278 14 Female 165.7 45.6 16.6 White Non-Hispanic/non- Latino08DEC2020 C4591001 1131 11311280 13 Female 166.4 50.5 18.2 White Non-Hispanic/non- Latino17DEC2020 C4591001 1131 11311281# 15 Female 157.5 79.4 32 White Non-Hispanic/non- Latino21DEC2020 C4591001 1131 11311282 15 Female 176.5 89.4 28.7 White Non-Hispanic/non- Latino22DEC2020 C4591001 1131 11311283 15 Male 180.4 73.3 22.5 White Non-Hispanic/non- Latino22DEC2020 C4591001 1131 11311285 14 Female 167.4 49.4 17.6 White Non-Hispanic/non- Latino23DEC2020 C4591001 1131 11311286 14 Male 174.1 54.5 18 White Non-Hispanic/non- Latino29DEC2020 C4591001 1131 11311287 12 Female 156.3 47.5 19.4 Black or African American Non-Hispanic/non- Latino29DEC2020 C4591001 1131 11311288 12 Female 159.9 55.3 21.6 Black or African American Non-Hispanic/non- Latino29DEC2020 C4591001 1131 11311289 15 Female 162.4 48 18.2 White Non-Hispanic/non- Latino30DEC2020 C4591001 1131 11311290 15 Female 161.9 53.3 20.3 White Non-Hispanic/non- Latino30DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 97 FDA-CBER-2022-5812-0223470 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1131 11311291 15 Female 170.7 68.4 23.5 White Non-Hispanic/non- Latino30DEC2020 C4591001 1131 11311292 15 Female 162.3 67.1 25.5 White Non-Hispanic/non- Latino04JAN2021 C4591001 1131 11311293 12 Female 151.2 39.8 17.4 White Non-Hispanic/non- Latino04JAN2021 C4591001 1131 11311294 13 Female 161.9 40.1 15.3 White Non-Hispanic/non- Latino05JAN2021 C4591001 1131 11311295 15 Female 165.7 63.6 23.2 White Non-Hispanic/non- Latino07JAN2021 C4591001 1131 11311296 15 Female 162.5 58.3 22.1 White Non-Hispanic/non- Latino08JAN2021 C4591001 1131 11311297 13 Male 161.9 52.8 20.1 White Non-Hispanic/non- Latino08JAN2021 C4591001 1131 11311298 14 Male 161.9 52.8 20.1 White Non-Hispanic/non- Latino08JAN2021 C4591001 1131 11311299 15 Male 167.5 67 23.9 White Non-Hispanic/non- Latino08JAN2021 C4591001 1131 11311300 13 Female 161.3 60.7 23.3 White Non-Hispanic/non- Latino08JAN2021 C4591001 1131 11311301 13 Male 161.2 45.5 17.5 White Non-Hispanic/non- Latino11JAN2021 C4591001 1131 11311302 15 Female 168.9 49.1 17.2 White Non-Hispanic/non- Latino11JAN2021 C4591001 1139 11391144 13 Male 163.83 44.82 16.7 White Non-Hispanic/non- Latino01DEC2020 C4591001 1139 11391145 12 Female 159.51 38.91 15.3 White Non-Hispanic/non- Latino01DEC2020 C4591001 1139 11391151 14 Male 172.72 54.55 18.2 White Non-Hispanic/non- Latino04DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 98 FDA-CBER-2022-5812-0223471 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1139 11391152 15 Female 173.99 53.36 17.6 White Non-Hispanic/non- Latino04DEC2020 C4591001 1139 11391154 12 Female 172.72 54.55 18.2 White Non-Hispanic/non- Latino04DEC2020 C4591001 1139 11391155 15 Male 186.18 65 18.7 White Non-Hispanic/non- Latino04DEC2020 C4591001 1139 11391156 14 Female 165.1 59.82 21.9 White Non-Hispanic/non- Latino07DEC2020 C4591001 1139 11391157 15 Male 179.07 70.09 21.8 Multiracial Non-Hispanic/non- Latino08DEC2020 C4591001 1139 11391158 13 Female 170.18 63.64 21.9 Multiracial Non-Hispanic/non- Latino08DEC2020 C4591001 1139 11391159 14 Female 167.64 58.73 20.9 White Non-Hispanic/non- Latino08DEC2020 C4591001 1139 11391161 14 Female 168.91 59.45 20.8 White Non-Hispanic/non- Latino08DEC2020 C4591001 1139 11391162 15 Male 188.47 67.55 19 White Non-Hispanic/non- Latino08DEC2020 C4591001 1139 11391163 13 Male 160.02 61.18 23.8 White Non-Hispanic/non- Latino08DEC2020 C4591001 1139 11391165 15 Male 172.21 57.82 19.5 White Non-Hispanic/non- Latino11DEC2020 C4591001 1139 11391166 15 Male 184.4 68.45 20.1 White Non-Hispanic/non- Latino11DEC2020 C4591001 1139 11391168 15 Male 179.58 67.45 20.9 White Non-Hispanic/non- Latino11DEC2020 C4591001 1139 11391169 15 Male 167.13 53.73 19.2 Asian Non-Hispanic/non- Latino15DEC2020 C4591001 1139 11391170# 13 Male 175.26 86.91 28.2 Asian Non-Hispanic/non- Latino15DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 99 FDA-CBER-2022-5812-0223472 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1139 11391171 15 Male 173.23 54.45 18.1 White Non-Hispanic/non- Latino15DEC2020 C4591001 1139 11391172 14 Female 167.64 45.45 16.1 White Non-Hispanic/non- Latino15DEC2020 C4591001 1139 11391173# 13 Female 156.97 71.45 28.9 White Hispanic/Latino 15DEC2020 C4591001 1139 11391174 15 Female 167.64 78.64 27.9 White Hispanic/Latino 15DEC2020 C4591001 1139 11391175 14 Female 154.94 45.45 18.9 Multiracial Non-Hispanic/non- Latino15DEC2020 C4591001 1139 11391177 15 Female 161.8 54.45 20.8 White Non-Hispanic/non- Latino17DEC2020 C4591001 1139 11391178 13 Female 157.48 48 19.3 White Non-Hispanic/non- Latino18DEC2020 C4591001 1139 11391179 15 Male 178.05 78.82 24.8 White Non-Hispanic/non- Latino18DEC2020 C4591001 1139 11391180 14 Female 175.26 56.82 18.5 White Non-Hispanic/non- Latino18DEC2020 C4591001 1139 11391181 15 Male 185.42 68 19.7 White Non-Hispanic/non- Latino18DEC2020 C4591001 1139 11391182 13 Female 153.67 42.45 17.9 White Non-Hispanic/non- Latino18DEC2020 C4591001 1139 11391183 14 Female 171.45 62.73 21.3 White Non-Hispanic/non- Latino18DEC2020 C4591001 1139 11391185 12 Male 151.13 41.36 18.1 White Non-Hispanic/non- Latino18DEC2020 C4591001 1139 11391186 14 Male 171.45 50.82 17.3 White Non-Hispanic/non- Latino21DEC2020 C4591001 1139 11391187 14 Male 170.18 60.36 20.8 Multiracial Non-Hispanic/non- Latino21DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 100 FDA-CBER-2022-5812-0223473 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1139 11391188 15 Female 161.29 53.73 20.6 White Non-Hispanic/non- Latino21DEC2020 C4591001 1139 11391189 13 Female 152.4 37.45 16.1 White Non-Hispanic/non- Latino21DEC2020 C4591001 1139 11391190 14 Male 182.12 51.73 15.6 White Non-Hispanic/non- Latino21DEC2020 C4591001 1139 11391191 13 Male 156.21 41.64 17 White Non-Hispanic/non- Latino21DEC2020 C4591001 1139 11391192 15 Male 170.18 44.59 15.4 White Non-Hispanic/non- Latino21DEC2020 C4591001 1139 11391193 12 Female 151.13 40.18 17.6 Multiracial Non-Hispanic/non- Latino21DEC2020 C4591001 1139 11391195 13 Male 171.96 55.09 18.6 White Non-Hispanic/non- Latino21DEC2020 C4591001 1139 11391196 15 Male 185.93 63.91 18.4 White Non-Hispanic/non- Latino21DEC2020 C4591001 1139 11391197 15 Male 168.15 57.09 20.1 White Non-Hispanic/non- Latino22DEC2020 C4591001 1139 11391198 15 Male 171.45 63.36 21.5 White Non-Hispanic/non- Latino22DEC2020 C4591001 1139 11391199 13 Male 167.64 49.55 17.6 White Non-Hispanic/non- Latino22DEC2020 C4591001 1139 11391200 12 Male 154.18 37.45 15.7 Asian Non-Hispanic/non- Latino22DEC2020 C4591001 1139 11391201 15 Male 170.18 62.73 21.6 White Non-Hispanic/non- Latino22DEC2020 C4591001 1139 11391202 12 Female 156.21 44.55 18.2 White Non-Hispanic/non- Latino22DEC2020 C4591001 1139 11391203 15 Female 166.88 54.18 19.4 White Non-Hispanic/non- Latino22DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 101 FDA-CBER-2022-5812-0223474 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1139 11391204 13 Male 156.21 43.09 17.6 White Non-Hispanic/non- Latino22DEC2020 C4591001 1139 11391205 15 Female 162.56 68.36 25.8 White Non-Hispanic/non- Latino22DEC2020 C4591001 1139 11391206 14 Male 153.67 35.73 15.1 White Non-Hispanic/non- Latino22DEC2020 C4591001 1139 11391207 12 Male 156.21 42.55 17.4 White Non-Hispanic/non- Latino22DEC2020 C4591001 1139 11391208 14 Female 165.1 46.36 17 White Non-Hispanic/non- Latino22DEC2020 C4591001 1139 11391209 12 Male 159.51 45.27 17.8 White Non-Hispanic/non- Latino22DEC2020 C4591001 1139 11391210 14 Male 166.37 61.91 22.3 White Non-Hispanic/non- Latino28DEC2020 C4591001 1139 11391211 15 Female 166.62 53.91 19.4 White Non-Hispanic/non- Latino28DEC2020 C4591001 1139 11391212 15 Female 161.29 52.82 20.3 White Non-Hispanic/non- Latino28DEC2020 C4591001 1139 11391213 14 Male 167.64 43.91 15.6 White Non-Hispanic/non- Latino28DEC2020 C4591001 1139 11391214 15 Female 167.13 74.27 26.5 Multiracial Non-Hispanic/non- Latino28DEC2020 C4591001 1139 11391215 14 Female 162.56 51.45 19.4 White Non-Hispanic/non- Latino29DEC2020 C4591001 1139 11391216 14 Female 167.64 59.09 21 White Non-Hispanic/non- Latino29DEC2020 C4591001 1139 11391217 13 Male 171.45 61.36 20.8 White Non-Hispanic/non- Latino29DEC2020 C4591001 1139 11391218 14 Female 166.88 40.45 14.5 White Non-Hispanic/non- Latino29DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 102 FDA-CBER-2022-5812-0223475 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1139 11391219 13 Female 164.34 57.18 21.1 White Non-Hispanic/non- Latino29DEC2020 C4591001 1139 11391220# 13 Female 173.99 86.36 28.5 White Non-Hispanic/non- Latino29DEC2020 C4591001 1139 11391221 14 Female 166.37 67.18 24.2 White Non-Hispanic/non- Latino04JAN2021 C4591001 1139 11391222 13 Male 170.18 53.82 18.5 White Non-Hispanic/non- Latino04JAN2021 C4591001 1139 11391223 13 Female 167.64 52.82 18.8 White Non-Hispanic/non- Latino04JAN2021 C4591001 1139 11391224 13 Male 159.26 48 18.9 White Non-Hispanic/non- Latino04JAN2021 C4591001 1139 11391225 12 Female 161.29 53.27 20.4 White Non-Hispanic/non- Latino04JAN2021 C4591001 1139 11391226 13 Female 147.32 43 19.8 White Non-Hispanic/non- Latino05JAN2021 C4591001 1139 11391227 13 Female 152.4 47.09 20.2 White Non-Hispanic/non- Latino05JAN2021 C4591001 1139 11391228 13 Male 179.07 63.82 19.9 White Hispanic/Latino 05JAN2021 C4591001 1139 11391229 14 Female 161.29 43.55 16.7 Asian Non-Hispanic/non- Latino05JAN2021 C4591001 1139 11391230 14 Female 178.31 68.36 21.5 White Non-Hispanic/non- Latino05JAN2021 C4591001 1139 11391231 15 Female 163.83 59.64 22.2 White Non-Hispanic/non- Latino05JAN2021 C4591001 1139 11391232 15 Female 147.32 41.64 19.1 White Non-Hispanic/non- Latino05JAN2021 C4591001 1139 11391233 15 Female 152.91 49.36 21.1 White Non-Hispanic/non- Latino05JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 103 FDA-CBER-2022-5812-0223476 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1139 11391235 15 Female 166.37 54.55 19.7 White Non-Hispanic/non- Latino05JAN2021 C4591001 1139 11391236 15 Female 165.1 60.45 22.1 Multiracial Non-Hispanic/non- Latino05JAN2021 C4591001 1139 11391237 12 Male 166.37 47.55 17.1 Black or African American Non-Hispanic/non- Latino07JAN2021 C4591001 1139 11391238# 13 Female 142.24 62.36 30.8 White Non-Hispanic/non- Latino07JAN2021 C4591001 1139 11391239 13 Male 165.1 43.18 15.8 White Non-Hispanic/non- Latino07JAN2021 C4591001 1139 11391240 12 Female 170.18 57.45 19.8 White Non-Hispanic/non- Latino08JAN2021 C4591001 1139 11391241 15 Male 178.31 78.45 24.6 Asian Non-Hispanic/non- Latino08JAN2021 C4591001 1139 11391242 15 Female 156.21 46.91 19.2 White Non-Hispanic/non- Latino08JAN2021 C4591001 1139 11391243 12 Female 167.13 47.91 17.1 White Non-Hispanic/non- Latino08JAN2021 C4591001 1139 11391244 14 Female 165.86 48.82 17.7 White Non-Hispanic/non- Latino08JAN2021 C4591001 1139 11391245# 14 Male 170.18 86.18 29.7 White Non-Hispanic/non- Latino08JAN2021 C4591001 1139 11391246 15 Male 179.07 71.82 22.3 White Non-Hispanic/non- Latino08JAN2021 C4591001 1139 11391247 15 Male 175.01 73 23.8 White Non-Hispanic/non- Latino08JAN2021 C4591001 1139 11391248# 15 Male 193.04 123.64 33.1 White Non-Hispanic/non- Latino08JAN2021 C4591001 1139 11391249 14 Female 171.45 62.45 21.2 White Non-Hispanic/non- Latino11JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 104 FDA-CBER-2022-5812-0223477 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1139 11391250 15 Female 160.02 51.82 20.2 White Non-Hispanic/non- Latino11JAN2021 C4591001 1139 11391251 13 Female 159.51 59.27 23.2 White Non-Hispanic/non- Latino11JAN2021 C4591001 1139 11391252 12 Female 160.02 48.55 18.9 White Non-Hispanic/non- Latino11JAN2021 C4591001 1139 11391253 14 Female 158.75 55.45 22 White Non-Hispanic/non- Latino11JAN2021 C4591001 1139 11391254 12 Male 149.86 37.64 16.7 White Non-Hispanic/non- Latino11JAN2021 C4591001 1139 11391255 14 Female 161.29 55.73 21.4 White Hispanic/Latino 11JAN2021 C4591001 1139 11391256 14 Female 161.29 44.64 17.1 White Non-Hispanic/non- Latino12JAN2021 C4591001 1139 11391257 12 Female 157.23 43.82 17.7 White Non-Hispanic/non- Latino12JAN2021 C4591001 1139 11391258 12 Male 151.13 39.73 17.4 Asian Non-Hispanic/non- Latino12JAN2021 C4591001 1139 11391259 12 Female 153.67 52.27 22.1 White Non-Hispanic/non- Latino12JAN2021 C4591001 1139 11391260 14 Female 162.56 53.91 20.4 White Non-Hispanic/non- Latino12JAN2021 C4591001 1139 11391261 15 Female 162.56 47.18 17.8 White Non-Hispanic/non- Latino12JAN2021 C4591001 1139 11391262 15 Male 165.1 50.55 18.5 White Non-Hispanic/non- Latino12JAN2021 C4591001 1139 11391263 15 Female 167.89 50.27 17.8 White Non-Hispanic/non- Latino12JAN2021 C4591001 1140 11401323# 12 Female 154.94 71.55 29.7 White Non-Hispanic/non- Latino10DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 105 FDA-CBER-2022-5812-0223478 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1140 11401324 14 Male 177.8 64.73 20.4 White Non-Hispanic/non- Latino10DEC2020 C4591001 1140 11401325 14 Male 165.1 69.09 25.3 White Non-Hispanic/non- Latino10DEC2020 C4591001 1140 11401326 12 Male 148.59 42.27 19.1 White Non-Hispanic/non- Latino10DEC2020 C4591001 1140 11401327 13 Female 166.37 55.27 19.9 White Non-Hispanic/non- Latino11DEC2020 C4591001 1140 11401328# 15 Female 156.21 76 31.1 White Non-Hispanic/non- Latino14DEC2020 C4591001 1140 11401329 14 Male 171.45 58.64 19.9 White Non-Hispanic/non- Latino14DEC2020 C4591001 1140 11401330 12 Male 141.61 30.45 15.2 White Non-Hispanic/non- Latino15DEC2020 C4591001 1140 11401331 14 Male 183.59 66.36 19.6 White Non-Hispanic/non- Latino16DEC2020 C4591001 1140 11401332 13 Female 172.72 60 20.1 White Non-Hispanic/non- Latino16DEC2020 C4591001 1140 11401333 15 Male 181 81 24.7 White Non-Hispanic/non- Latino16DEC2020 C4591001 1140 11401334 13 Female 167.89 66.45 23.5 White Non-Hispanic/non- Latino16DEC2020 C4591001 1140 11401335 14 Female 156.85 53.18 21.6 White Non-Hispanic/non- Latino17DEC2020 C4591001 1140 11401336 13 Female 156.9 53 21.5 White Non-Hispanic/non- Latino17DEC2020 C4591001 1140 11401337 15 Female 171.45 75 25.5 White Non-Hispanic/non- Latino17DEC2020 C4591001 1140 11401338 15 Female 162.56 49.91 18.8 White Non-Hispanic/non- Latino17DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 106 FDA-CBER-2022-5812-0223479 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1140 11401340 12 Female 160.02 53.45 20.8 White Non-Hispanic/non- Latino21DEC2020 C4591001 1140 11401343# 13 Female 146.05 70.82 33.1 American Indian or Alaska Native Non-Hispanic/non- Latino21DEC2020 C4591001 1140 11401344 13 Female 153.67 58 24.5 Multiracial Non-Hispanic/non- Latino21DEC2020 C4591001 1140 11401345 15 Male 180.39 61.45 18.8 White Non-Hispanic/non- Latino22DEC2020 C4591001 1140 11401347# 13 Male 182.91 105.45 31.5 White Non-Hispanic/non- Latino22DEC2020 C4591001 1140 11401348 12 Female 166.37 65.64 23.7 White Non-Hispanic/non- Latino22DEC2020 C4591001 1140 11401349 14 Female 165.4 49.55 18.1 White Non-Hispanic/non- Latino22DEC2020 C4591001 1140 11401350 15 Female 154.94 48.82 20.3 White Non-Hispanic/non- Latino22DEC2020 C4591001 1140 11401351 13 Male 162.61 62.27 23.5 White Non-Hispanic/non- Latino22DEC2020 C4591001 1140 11401352 15 Male 167.64 54.27 19.3 White Non-Hispanic/non- Latino22DEC2020 C4591001 1140 11401353# 12 Male 162 69.45 26.4 White Non-Hispanic/non- Latino22DEC2020 C4591001 1140 11401354 15 Female 162.56 49.27 18.6 White Non-Hispanic/non- Latino23DEC2020 C4591001 1140 11401356 14 Female 153.7 54.36 23 Multiracial Non-Hispanic/non- Latino23DEC2020 C4591001 1140 11401357 15 Female 156.9 64.91 26.3 White Non-Hispanic/non- Latino23DEC2020 C4591001 1140 11401358 13 Female 141.99 30.36 15 White Non-Hispanic/non- Latino23DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 107 FDA-CBER-2022-5812-0223480 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1140 11401359 14 Male 170.82 53.27 18.2 Asian Non-Hispanic/non- Latino23DEC2020 C4591001 1140 11401361# 14 Female 171.45 91.91 31.2 White Non-Hispanic/non- Latino28DEC2020 C4591001 1140 11401362 14 Male 179.1 61.55 19.1 White Non-Hispanic/non- Latino28DEC2020 C4591001 1140 11401363 13 Male 162.56 53.82 20.3 White Non-Hispanic/non- Latino28DEC2020 C4591001 1140 11401364 14 Male 172.8 51.91 17.3 White Non-Hispanic/non- Latino28DEC2020 C4591001 1140 11401365 15 Male 180.34 88.73 27.2 White Non-Hispanic/non- Latino28DEC2020 C4591001 1140 11401366# 13 Female 160.1 71.91 28 White Non-Hispanic/non- Latino28DEC2020 C4591001 1140 11401367 12 Female 142.24 34.55 17 White Non-Hispanic/non- Latino28DEC2020 C4591001 1140 11401369 14 Female 173.99 61.55 20.3 White Non-Hispanic/non- Latino29DEC2020 C4591001 1140 11401370 14 Male 158.8 47.73 18.9 White Non-Hispanic/non- Latino29DEC2020 C4591001 1140 11401371 12 Male 155.58 36.73 15.1 White Non-Hispanic/non- Latino29DEC2020 C4591001 1140 11401372 13 Female 155.6 39 16.1 White Non-Hispanic/non- Latino29DEC2020 C4591001 1140 11401373 14 Female 161.29 54.18 20.8 White Non-Hispanic/non- Latino29DEC2020 C4591001 1140 11401374 14 Female 159.39 56.09 22 White Non-Hispanic/non- Latino29DEC2020 C4591001 1140 11401375 15 Female 147.32 43.09 19.8 White Non-Hispanic/non- Latino29DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 108 FDA-CBER-2022-5812-0223481 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1140 11401376 14 Female 166.12 56.27 20.3 White Non-Hispanic/non- Latino29DEC2020 C4591001 1140 11401377 12 Female 158.19 56.45 22.5 White Non-Hispanic/non- Latino29DEC2020 C4591001 1140 11401378 13 Male 176.61 75.64 24.2 White Non-Hispanic/non- Latino29DEC2020 C4591001 1140 11401379 12 Male 148.59 39 17.6 Black or African American Non-Hispanic/non- Latino30DEC2020 C4591001 1140 11401380 15 Female 163.2 59.27 22.2 White Non-Hispanic/non- Latino30DEC2020 C4591001 1140 11401381# 14 Male 161.29 74.55 28.6 White Non-Hispanic/non- Latino30DEC2020 C4591001 1140 11401382 15 Female 153.7 51.64 21.8 White Non-Hispanic/non- Latino30DEC2020 C4591001 1140 11401383 14 Male 162.56 55.82 21.1 White Non-Hispanic/non- Latino30DEC2020 C4591001 1140 11401384 14 Female 160.1 62.09 24.2 White Non-Hispanic/non- Latino30DEC2020 C4591001 1140 11401385 12 Female 165.4 54.36 19.8 White Non-Hispanic/non- Latino30DEC2020 C4591001 1140 11401386 15 Male 177.19 61 19.4 White Non-Hispanic/non- Latino30DEC2020 C4591001 1140 11401387# 12 Male 153.7 65.64 27.7 White Non-Hispanic/non- Latino30DEC2020 C4591001 1140 11401388 15 Male 172.8 74.64 24.9 White Non-Hispanic/non- Latino05JAN2021 C4591001 1140 11401389# 13 Female 162.61 73.82 27.9 White Non-Hispanic/non- Latino05JAN2021 C4591001 1140 11401390 15 Male 175.77 80.18 25.9 White Non-Hispanic/non- Latino05JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 109 FDA-CBER-2022-5812-0223482 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1140 11401391 12 Female 158.8 53.64 21.2 Multiracial Non-Hispanic/non- Latino06JAN2021 C4591001 1140 11401392 15 Male 163.58 60.64 22.6 White Hispanic/Latino 06JAN2021 C4591001 1140 11401393 14 Male 166.12 53.73 19.4 White Non-Hispanic/non- Latino06JAN2021 C4591001 1140 11401394# 15 Male 186.94 105.73 30.2 White Non-Hispanic/non- Latino06JAN2021 C4591001 1140 11401395 12 Female 161.29 50 19.2 White Non-Hispanic/non- Latino07JAN2021 C4591001 1140 11401396 12 Female 165.4 69.27 25.3 White Non-Hispanic/non- Latino07JAN2021 C4591001 1140 11401397 13 Female 160.1 51.82 20.2 White Non-Hispanic/non- Latino08JAN2021 C4591001 1140 11401398# 14 Male 171.5 81 27.5 White Non-Hispanic/non- Latino08JAN2021 C4591001 1140 11401399 15 Male 178.05 67.64 21.3 White Non-Hispanic/non- Latino08JAN2021 C4591001 1140 11401400 13 Male 157.51 39.45 15.9 White Non-Hispanic/non- Latino08JAN2021 C4591001 1140 11401401 15 Male 180.34 53.64 16.5 White Non-Hispanic/non- Latino08JAN2021 C4591001 1140 11401402 12 Female 151.79 33.91 14.7 White Non-Hispanic/non- Latino08JAN2021 C4591001 1140 11401403 12 Female 157.99 46.45 18.6 White Non-Hispanic/non- Latino08JAN2021 C4591001 1142 11421318 15 Male 167.64 75.09 26.7 White Non-Hispanic/non- Latino01DEC2020 C4591001 1142 11421319# 12 Female 154.94 85.64 35.6 White Hispanic/Latino 01DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 110 FDA-CBER-2022-5812-0223483 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1142 11421321# 12 Male 162.56 94.91 35.8 Black or African American Hispanic/Latino 02DEC2020 C4591001 1142 11421323# 13 Male 172.72 95 31.8 White Non-Hispanic/non- Latino03DEC2020 C4591001 1142 11421324 12 Male 138.43 29.05 15.1 White Hispanic/Latino 03DEC2020 C4591001 1142 11421325 13 Female 167.64 50.86 18.1 White Hispanic/Latino 03DEC2020 C4591001 1142 11421326 12 Female 154.94 39.36 16.4 White Non-Hispanic/non- Latino03DEC2020 C4591001 1142 11421327 12 Male 153.67 43.68 18.5 White Hispanic/Latino 03DEC2020 C4591001 1142 11421329 14 Female 172.72 70.77 23.7 White Hispanic/Latino 04DEC2020 C4591001 1142 11421330 13 Male 152.4 56.5 24.3 White Hispanic/Latino 04DEC2020 C4591001 1142 11421333 13 Male 162.56 48.05 18.1 Not reported Hispanic/Latino 18DEC2020 C4591001 1142 11421335 13 Female 162.56 70 26.4 White Non-Hispanic/non- Latino04DEC2020 C4591001 1142 11421340 13 Female 165.1 52.82 19.3 White Non-Hispanic/non- Latino07DEC2020 C4591001 1142 11421341# 14 Male 167.64 84.45 30 White Non-Hispanic/non- Latino07DEC2020 C4591001 1142 11421342 15 Male 175.26 64.36 20.9 White Non-Hispanic/non- Latino07DEC2020 C4591001 1142 11421343 14 Female 161.93 63.91 24.3 Multiracial Non-Hispanic/non- Latino08DEC2020 C4591001 1142 11421344 13 Female 156.21 50.91 20.8 Not reported Hispanic/Latino 08DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 111 FDA-CBER-2022-5812-0223484 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1142 11421345 15 Female 158.75 70.41 27.9 Not reported Hispanic/Latino 08DEC2020 C4591001 1142 11421346 13 Female 168.91 63.36 22.2 White Non-Hispanic/non- Latino10DEC2020 C4591001 1142 11421348 12 Male 177.8 60.59 19.1 White Non-Hispanic/non- Latino10DEC2020 C4591001 1142 11421349 15 Male 170.18 51.86 17.9 White Hispanic/Latino 10DEC2020 C4591001 1142 11421350 13 Male 172.72 71.82 24 Black or African American Non-Hispanic/non- Latino10DEC2020 C4591001 1142 11421351# 15 Female 170.18 86.36 29.8 White Non-Hispanic/non- Latino11DEC2020 C4591001 1142 11421352 13 Male 162.56 56.36 21.3 White Non-Hispanic/non- Latino11DEC2020 C4591001 1142 11421353 14 Male 171.45 58.95 20 White Hispanic/Latino 11DEC2020 C4591001 1142 11421354 14 Female 167.64 56.05 19.9 Black or African American Non-Hispanic/non- Latino11DEC2020 C4591001 1142 11421355# 12 Male 170.18 81.73 28.2 Multiracial Non-Hispanic/non- Latino14DEC2020 C4591001 1142 11421356 14 Female 161.29 61.95 23.8 Black or African American Non-Hispanic/non- Latino14DEC2020 C4591001 1142 11421358 13 Female 157.48 56.91 22.9 Black or African American Non-Hispanic/non- Latino15DEC2020 C4591001 1142 11421359# 15 Male 162.56 100 37.8 Multiracial Non-Hispanic/non- Latino15DEC2020 C4591001 1142 11421360# 13 Male 162.56 87.77 33.1 Black or African American Non-Hispanic/non- Latino15DEC2020 C4591001 1142 11421361 12 Male 149.86 43.05 19.1 White Hispanic/Latino 16DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 112 FDA-CBER-2022-5812-0223485 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1142 11421362 13 Female 160.02 51.23 20 White Non-Hispanic/non- Latino16DEC2020 C4591001 1142 11421363 13 Male 165.1 49.18 18 White Non-Hispanic/non- Latino16DEC2020 C4591001 1142 11421364 12 Female 153.67 46.59 19.7 White Non-Hispanic/non- Latino18DEC2020 C4591001 1142 11421365 12 Male 154.94 42.77 17.8 White Non-Hispanic/non- Latino18DEC2020 C4591001 1142 11421366 15 Male 162.56 65.05 24.6 White Non-Hispanic/non- Latino21DEC2020 C4591001 1142 11421367 12 Male 149.86 43.36 19.3 White Non-Hispanic/non- Latino21DEC2020 C4591001 1142 11421368 12 Male 165.1 49.27 18 White Non-Hispanic/non- Latino21DEC2020 C4591001 1142 11421369 13 Female 160.02 53.14 20.7 White Hispanic/Latino 21DEC2020 C4591001 1142 11421370 13 Female 165.1 69.14 25.3 White Non-Hispanic/non- Latino21DEC2020 C4591001 1142 11421371 13 Male 173.99 57.59 19 White Non-Hispanic/non- Latino21DEC2020 C4591001 1142 11421372# 13 Male 154.94 69.91 29.1 White Non-Hispanic/non- Latino22DEC2020 C4591001 1142 11421373# 15 Male 180.34 109.09 33.5 Black or African American Non-Hispanic/non- Latino22DEC2020 C4591001 1142 11421374 14 Female 165.1 64.23 23.5 Black or African American Non-Hispanic/non- Latino22DEC2020 C4591001 1142 11421375# 12 Male 175.26 93.64 30.4 White Non-Hispanic/non- Latino22DEC2020 C4591001 1142 11421376# 12 Female 163.83 75.41 28 White Non-Hispanic/non- Latino22DEC2020 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 113 FDA-CBER-2022-5812-0223486 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1142 11421377 14 Female 158.75 53.68 21.3 White Hispanic/Latino 22DEC2020 C4591001 1142 11421379 13 Male 162.56 45.55 17.2 White Non-Hispanic/non- Latino28DEC2020 C4591001 1142 11421380 15 Male 162.56 54.14 20.4 Asian Non-Hispanic/non- Latino28DEC2020 C4591001 1142 11421383 15 Male 184.15 79.36 23.4 White Non-Hispanic/non- Latino29DEC2020 C4591001 1142 11421384 13 Female 162.56 48.5 18.3 Not reported Hispanic/Latino 29DEC2020 C4591001 1142 11421385 15 Male 170.18 65.82 22.7 Not reported Hispanic/Latino 31DEC2020 C4591001 1142 11421386 13 Male 162.56 44.77 16.9 Not reported Hispanic/Latino 31DEC2020 C4591001 1142 11421388# 15 Male 172.72 120.91 40.4 White Non-Hispanic/non- Latino05JAN2021 C4591001 1142 11421389 14 Male 163.83 58.09 21.6 White Hispanic/Latino 06JAN2021 C4591001 1142 11421390 13 Female 140.97 50.64 25.4 White Non-Hispanic/non- Latino06JAN2021 C4591001 1142 11421391 13 Male 158.75 40.55 16.1 White Non-Hispanic/non- Latino06JAN2021 C4591001 1142 11421392 15 Male 175.26 50.64 16.4 White Non-Hispanic/non- Latino08JAN2021 C4591001 1142 11421393 13 Male 162.56 67.73 25.6 White Non-Hispanic/non- Latino08JAN2021 C4591001 1142 11421394 14 Male 162.56 58.18 22 Not reported Hispanic/Latino 11JAN2021 C4591001 1142 11421395 13 Male 171.45 48.68 16.5 Multiracial Hispanic/Latino 11JAN2021 090177e196ac915a\Final\Final On: 31-Mar-2021 13:05 (GMT) Page 114 FDA-CBER-2022-5812-0223487 16.2.4.1 Listing of Demographic Characteristics – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Age (Years) Sex Height (cm) Weight (kg) Body Mass Index (BMI) (kg/m2) Race Ethnicity Informed Consent Date (Screening) C4591001 1142 11421396 15 Female 149.86 38.05 16.9 White Non-Hispanic/non- Latino11JAN2021 C4591001 1147 11471261 13 Female 165.7 56.05 20.4 White Non-Hispanic/non- Latino01DEC2020 C4591001 1147 11471262 14 Female 165.2 65.15 23.9 White Non-Hispanic/non- Latino01DEC2020 C4591001 1147 11471263 12 Male 149.9 45.1 20.1 White Non-Hispanic/non- Latino05DEC2020 C4591001 1147 11471264 14 Male 184.4 76.95 22.6 White Non-Hispanic/non- Latino05DEC2020 C4591001 1147 11471268 12 Female 157.48 58.2 23.5 White Non-Hispanic/non- Latino05DEC2020 C4591001 1147 11471269 15 Female 170.4 51.75 17.8 White Non-Hispanic/non- Latino05DEC2020 C4591001 1147 11471270 15 Female 168.2 54.4 19.2 White Non-Hispanic/non- Latino05DEC2020 C4591001 1147 11471271 15 Female 165.1 54.7 20.1 White Non-Hispanic/non- Latino05DEC2020 C4591001 1147 11471273# 13 Female 176.3 89.2 28.7 Black or African American Non-Hispanic/non- Latino05DEC2020 C4591001 1147 11471274 12 Female 155.96 44.84 18.4 White Non-Hispanic/non- Latino05DEC2020 C4591001 1147 11471275 13 Female 174.5 65.3 21.4 Black or African American Non-Hispanic/non- Latino05DEC2020 C4591001 1147 11471277# 15 Female 161.1 75.1 28.9 White Non-Hispanic/non- Latino08DEC2020 C4591001 1147 11471278 13 Male 160.02 48. …[truncated]