Power and Sample Size
The sample size was calculated based on the AE ascertainment (moderate or severe) occurring between the postoperative days 1 and 14. The noninferiority margin of −0.25% was set as the lower bound of a 95% CI for the maximum mean difference in the rate of cumulative AEs between the control and 2wT arms to conclude that 2wT is noninferior. This margin was set considering the mean AE rate of 0.5% in routine SSA VMMC programs at scale [