Subjects and baseline characteristics
The pooled population comprised 929 randomised subjects (471 subjects treated with 12 SQ-Bet and 458 subjects treated with placebo) aged 12 to 65 years. Of the population exposed to 12 SQ-Bet, 35 subjects (7%) were adolescents. All randomised subjects received at least 1 dose of IMP. A total of 832 subjects (90%) completed the trials. Overall, the treatment groups appeared to be similar (Table 1).
Of subjects exposed to 12 SQ-Bet, 88% were exposed for 24-41 weeks, and twelve percent for less than 24 weeks. The average treatment duration of the three phase-II/III trials varied between 23 and 32 weeks.