Interim analyses {21b}
The data management and safety board (DSMB) will act as an advisory capacity to the Trial Steering Committee (TSC), to safeguard the interest of trial participants and to review the results of the interim analyses. It will also provide the TSC with recommendations on the continuation, premature closure of the trial or of single experimental treatment arms or extension of the study. The DSMB will meet at least every 6 months and more often if needed.