Statistical Analysis
ADVERSE EVENTS, SECONDARY
All analyses were specified a priori, and no interim analyses were conducted. Baseline characteristics were described using medians and IQRs for continuous variables and frequency and percentages for categorical variables.All analyses followed the intention-to-treat principle. The between-group difference in primary outcome was assessed using a 2-sided Fisher exact test. The estimated effect was reported as a relative risk difference with corresponding 95% CIs and For secondary analyses, the between-group differences in secondary outcomes were similarly assessed using a Fisher exact test and reported as relative risk differences with 95% CIs and Because adverse events were uncommon, these were reported in a descriptive way. Overall significance for all analyses was set at 