Early termination
ADVERSE EVENTS
According to protocol, the trial would be terminated after the interim analysis in case of a statistically significant higher rate of adverse events in the intervention group without a clinically relevant increase in sensitivity. Furthermore, rules for efficacy (according to the Haybittle-Peto rule) and futility (based on the O’Brien & Fleming method) were incorporated in the study protocol. The results of the interim analysis at 50% (