Statistical methods
depressive symptoms
ADVERSE EVENTS, EVENTS, REMISSION
The number (percentage) of participants with adverse events, including events of clinical interest, serious adverse events, and adverse events leading to premature discontinuation of study drug were summarized by preferred term. Descriptive statistics were provided for other safety parameters.Descriptive statistics and frequency distributions were used to summarize the efficacy data. Efficacy endpoints for both the induction and optimization/maintenance phases comprise the following: change from baseline in depressive symptoms (MADRS and PHQ-9), including response (≥50% improvement from baseline) and remission (MADRS total score ≤ 12; PHQ-9 total score < 5 [