Author contributions
JMW contributed to the design of the analytic approach, and primarily led the development of the manuscript. RB was the principal investigator of the original trial and contributed to the development of the manuscript. LRS, CEDS, and TLP assisted with interpretation of results and contributed to the development of the manuscript. SS conducted the statistical analysis. EVP garnered funding to support the analysis in this study, conceptualized the aims and approach for this analysis, and co-led the development of the manuscript.