Reproducible research
The protocol for this study will be published on ClinicalTrials.gov at the completion of the study. The dataset and statistical code will be available by request to the investigative team.TrialRecruitment for this trial began on February 1, 2022. We anticipate enrollment to be completed by the end of 2023. At the time this manuscript is being written, protocol version 2.0 from 11/15/2022 is in use.