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Primary (A, B) and secondary (C, D) efficacy endpoints for RCT and OLE phases (ITT analysis set). ap<0.05, bp<0.01, cp<0.001. For RCT period, baseline is day 1. For OLE periods, baseline is last available observation from the RCT period. CGI-S, Clinical Global Impressions–Severity; CI, confidence interval; ITT, intention to treat; OLE, open-label extension; RCT, randomized controlled trial; YMRS, Young Mania Rating Scale.
