Analyses
OI
The efficacy and safety analysis set were the same. Both were defined as participants who received at least 1 maintenance dose (third injection on week 9) of 300 mg or 100 mg of BUP-XR. The effects of BUP-XR maintenance dose (300 mg vs. 100 mg) on efficacy and safety outcomes were analyzed separately for OI and NIO. Baseline characteristics were summarized by the maintenance dose groups (BUP-XR 300 mg vs. 100 mg) for OI versus NIO populations.