Contributors
AD
RECRUITMENT
MDS and PJC were principal investigators and RR and JMS the co-principal investigators. MDS and PJC designed the trial and the study protocol. MDS, HG, and PJC in collaboration with lead site investigators and local study teams led and participated in the site work, including the recruitment, follow-up, and data collection. MDS, HG, and PJC contributed to study supervision. MDS, HG, AD, and PJC contributed to the data analysis, data interpretation, and revision of the article. MDS, PJC, HG, and AD had access to the data, verified the data, and were responsible for the decision to submit the manuscript. AD was responsible for statistical analysis. The first draft of the manuscript was written by MDS, HG, and PJC. AD and JMS contributed to the critical review and revision of the article. All authors contributed to the review of the revision of the article and vouch for the accuracy and completeness of the data and the fidelity of the trial to the protocol. The corresponding author has full access to all the data in the study and had final responsibility for the decision to submit for publication.