Composition of the data monitoring committee, its role and reporting structure {21a}
RECRUITMENT
Due to the low risk of the study, a formal data monitoring committee was not formed. There are no formal stopping rules for the trial because there are no anticipated problems that are detrimental to all participants. The principal investigators will review all data collection forms and electronic databases on an ongoing basis for data completeness and accuracy as well as protocol compliance. The research assistant will report weekly on recruitment, participants retained, and whether any issues with confidentiality or unexpected participant or data issues have arisen.