Composition of the coordinating center and trial steering committee {5d}
ADVERSE EVENTS, RECRUITMENT
The coordinating center and trial steering committee is composed of 3 study physicians and one study coordinator that will oversee patient recruitment and enrolment, the progression of recruitment, evaluation of adverse events, and monitoring of subject drop-out. The committee will convene one every 2 weeks during the study during which one participant of the committee will give a presentation with all current data regarding the trial. After completion of the study, the committee will become the data management team and assess completion of data collection and will prepare the data files for analyses.