Statistical analysis
Depression, Anxiety
SECONDARY, EVALUABLE
The safety set included all patients who received blinded study drug. The full analysis set (FAS) included all randomized patients in the safety set with a valid baseline and ≥1 postbaseline total score on at least one of the efficacy assessments (HAMD-17, Hamilton Rating Scale for Anxiety [HAM-A], Montgomery-Åsberg Depression Rating Scale [MADRS], or the 9-item Patient Health Questionnaire) or those with a valid baseline and ≥1 postbaseline value on the Clinical Global Impressions-Improvement score and/or Clinical Global Impression-Severity score.A sample size of 382 evaluable patients was determined to provide 90% power to detect a statistically significant difference in the primary endpoint using a two-sided alpha level of 0.05, assuming the true difference is 3 points and a standard deviation (SD) of 9 points. Evaluable patients were those who were randomized and received blinded study drug and had a valid baseline and ≥1 postbaseline HAMD-17 assessment.Continuous endpoints, including the primary and key secondary endpoints, were analyzed using a mixed effects model for repeated measures. Multiplicity adjustment of the key secondary endpoint was conducted by using the fixed sequence strategy [