Statistical analysis
MDD
REGRESSION, REMISSION
The analysis set included all randomized patients from ASPIRE I and ASPIRE II. The Kaplan–Meier product-limit method was used to estimate the median time (95% confidence interval [CI]) to remission of MDD from baseline. Univariate and multivariable Cox proportional hazards regression models were used to estimate hazard ratio (HR). The multivariable Cox hazards regression model included treatment and baseline score as covariates, and analysis center and SOC antidepressant treatment at baseline as stratification factors. For the number of days in remission, a Mann–Whitney U test was used to compare the median percent of days in remission between treatment arms. No adjustment for multiple comparisons was made.