Statistical analysis
suicidality
SECONDARY
No formal sample size calculations were performed for this study. There was no imputation for missing efficacy data and the observed data were used in statistical analyses.Safety analyses were performed on the safety analysis set which included all participants who received psilocybin. Descriptive statistics were used to analyze safety data including TEAEs, concomitant treatments, evaluations of vital signs, clinical laboratory tests, findings from 12-lead ECGs, and suicidality assessments (C-SSRS).Efficacy analyses were performed on the full analysis set which included all participants who received psilocybin and had at least one post-Baseline efficacy assessment. The primary efficacy end point (change from Baseline to Week 3 in the MADRS total score) was evaluated with the use of descriptive summaries using statistics for continuous variables. Similarly, the secondary and exploratory efficacy end points were also summarized descriptively.