Outcomes
The primary outcomes of interest were safety and workload. The primary safety outcome was the cumulative AE rate (moderate or severe) ≤day 14 and was calculated per arm as follows: (sum of moderate and severe AEs) / (total number of 2wT participants who had a clinic visit before or on day 14). Similar to the preceding RCT, the safety outcome of cumulative AE rate reported before or on the final study visit on day 14 included a range of 13 to 22 days after VMMC to provide a reasonable margin for participant delays [