Plans to give access to the full protocol, participant-level data, and statistical code {31c}
This study will comply with the NIH Public Access Policy, which ensures that the public has access to the published results of NIH-funded research. The study will also comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.As such, this study will:Register with ClinicalTrials.gov and submit results. We will submit primary outcome results from this trial to ClinicalTrials.gov.Publish results. We will make every attempt to publish results in peer-reviewed journals. We will submit all final peer-reviewed journal manuscripts from this study to the digital archive PubMed Central upon acceptance for publication.Deposit data for data sharing with other researchers. Within the bounds of relevant IRB approvals and guidelines for protection of personally identifiable data, we will deposit de-identified data from this study in an appropriate, NIH-approved data repository.