Authors’ contributions
AEC, HRT and WLL drafted the original manuscript. WLL is the lead investigator who designed the trial, and is responsible for sequential randomization of participants and oversight of data collection and analysis. WLL is responsible for reporting significant protocol modifications to the IRB and the ClinicalTrials.gov trial registry. HRT, ST and WLL drafted IRB documents. LJ is the lead biostatistician. AEC, HRT, LJ and WLL will have access to the final trial dataset. WLL will be responsible for dissemination of de-identified study results at professional meetings and through research publications. Eligible co-authors are individuals who participated in study design and/or participant enrollment. All authors contributed edits, reviewed and approved the final manuscript.