Composition of the data monitoring committee, its role and reporting structure
An independent board of senior researchers who have no competing interests will be appointed as the data safety monitoring committee. The data safety monitoring committee will review and evaluate the accumulated study data for participants’ safety and study progress on a monthly basis. They will serve in an individual capacity and provide their expertise and recommendations throughout the study and will be responsible for making recommendations to the research team concerning the continuation, modification, or termination of the trial.