The Executive Committee will approve the final trial design and protocol. This committee will also be responsible for reviewing the final results, determining the methods of presentation and publication, and selection of secondary projects and publications. Members of the committee will include the PI and persons who will organize this study. The Data Safety Monitoring Board (DSMB) will review the safety data from this study and make recommendations based on safety analyses of serious adverse events and protocol deviation. The Clinical Events Committee will meet regularly to review and adjudicate all clinical events that occur throughout the study period. The statistical analysis will be performed according to the prespecified analysis plan as described in the study protocol.