Availability of data and materials
Given concerns about confidentiality and waiver of consent, datasets generated for the present study will not be made publicly available. Access to the full final protocol, deidentified data, and statistical analysis will be made available from the study principal investigator upon reasonable request after the publication of primary trial results. The protocol described herein was registered with ClinicalTrials.gov on 25 March 2019 (No. NCT03892967). Primary findings from this study will be reported to ClinicalTrials.gov.