Placebo
Placebo
Placebo adolescents Placebo adolescents Placebo adults Placebo adults
12 SQ-Bet
12 SQ-Bet
12 SQ-Bet adolescents 12 SQ-Bet adolescents 12 SQ-Bet adults 12 SQ-Bet adults
(N=458) (N=458) (N=37) (N=37) (N=421) (N=421) (N=471) (N=471) (N=35) (N=35) (N=436) (N=436)
Subjects reporting N (%n) N (%n) N (n%) N (n%) N (%n) N (%n)
Treatment emergent AEs 289 (63%) 22 (59%) 267 (63%) 402 (85%) 29 (83%) 373 (86%)
AEs related to IMP 144 (31%) 10 (27%) 134 (32%) 373 (79%) 28 (80%) 345 (79%)
Severe treatment emergent AEs 12 (3%) 1 (3%) 11 (3%) 39 (8%) 2 (6%) 37 (8%)
Severe AEs related to IMP 2 (<1%) 1 (3%) 1 (<1%) 22 (5%) 1 (3%) 21 (5%)
Serious treatment emergent AEs 6 (1%) 6 (1%) 9 (2%) 9 (2%)
Serious AEs related to IMP 1 (<1%) 1 (<1%) 1 (<1%) 1 (<1%)
Treatment emergent AEs leading to discontinuation 11 (2%) 11 (3%) 39 (8%) 1 (3%) 38 (9%)
AEs related to IMP leading to discontinuation 8 (2%) 8 (2%) 33 (7%) 1 (3%) 32 (7%)