Trial Sequential Analysis of the effects of simeprevir versus placebo or no intervention on risk of serious adverse events. The analysis was based on a proportion in the control group (Pc) of 8.4%, a relative risk reduction (RRR) of 20%, and alfa of 2.5%, a beta of 20%, and a diversity of 0%. The cumulative Z‐curve crosses the naive type I error level of 5%, but does not cross the trial monitoring boundary for benefit.