Statistical analysis
EVENTS, SECONDARY
On the basis of our own experienceData for the primary and secondary endpoints were analyzed with the intention-to-treat approach and per protocol. The intention-to-treat analysis included all randomly assigned patients who received at least one day of treatment. As the two analyses produced virtually the same results, only the intention-to-treat analysis is presented in detail. All patients who received at least one dose of treatment were included in the safety analysis. Main efficacy analyses and the proportion of treatment success at day 7 were compared between groups using a two-sided chi-squared test. Relative risks for study outcomes were calculated and reported with 95% confidence intervals. The incidences of events in secondary outcomes were compared using the chi-squared test, Fisher’s exact test or the Mann–Whitney test. Kaplan–Meier curves for survival were constructed and compared using the log-rank test. All analyses and data management were performed with R software, v.4.0.4 or later