Plans to give access to the full protocol, participant level-data, and statistical code {31c}
The study’s protocol will be published in a peer-reviewed journal, and it will be submitted, alongside the manuscript reporting the main results of the trial, following trial completion. The study will also comply with the NIH’s Data Management and Sharing Policy. In addition, this trial has been registered at ClinicalTrials.gov (NCT05219110), and the record will be updated in accordance with their policies. The statistical code used to analyze study data will be shared upon reasonable request. The data and supporting information will be made available and will remain open access in the public domain within 3 years following completion of the study protocol by the last enrolled participant.