Study design and participants
ACTIVE-J was a multicenter, randomized, double-blind, parallel group, PBO-controlled, phase 3 trial in which patients were randomized 2:1 to receive 80 μg of ABL (daily subcutaneous self-injection) or PBO for 18 months (78 weeks). The study period spanned from the day of obtaining informed consent to the day of the last visit, defined as the week 78 visit, or the day of withdrawal from the study, or the last day of tests after withdrawal. The study participants, described previously in detail [