Data monitoring committee
deaths
ADVERSE EVENTS, RECRUITMENT
An independent Data Monitoring Committee (DMC) has been established, that consists of two medical scientists and one statistician with longstanding experience in clinical trials. The DMC’s function is to monitor the study’s course and if necessary, make recommendations to the coordinating or principal investigator for study continuation, modification or discontinuation. The DMC members will be informed about patient recruitment, adherence to the protocol, observed serious adverse events and deaths by receiving the development safety update reports (DSURs) at regular intervals.