Composition of the data monitoring committee, its role and reporting structure {21a}
An independent DSMB with seven members including representatives of each study country has been assembled for this study. The details for the operation and responsibilities of the DSMB are defined in a DSMB Charter. The Charter delineates the composition, duties, responsibilities, and procedures of the DSMB, the data required at each meeting as well as any analyses that will be conducted.After each DSMB meeting, the Chairperson will issue a written report describing all recommendations