Statistical Analysis
CVD, SECONDARY, EVENT
The trial’s statistical analysis plan is available in Analysis of the primary safety end point and event-based secondary end points used a discrete-time proportional hazards modelChanges over time in IPSSs, PSA levels, and hormone levels were analyzed using linear mixed-effects models with fixed effects for treatment, visit, treatment × visit interaction, baseline value, CVD status, and a random-subject effect using an unstructured covariance. Least-squares means estimates, 95% CIs, and The study was powered to establish noninferiority for the MACE end point within a noninferiority margin of an upper confidence limit of the HR less than 1.5. Approximately 6000 individuals were to be recruited to accrue 256 MACEs (90% power) under the initial assumptions of annual event rate, accrual rate, and discontinuation rate.