Contributors
SAM conceived the trial and is the national principal investigator. SAM, GK, CLC, VB, SCG, AJP, PLM and AI wrote the protocol and designed the trial. SAM, ALK, AI, CLC, VB, CT, PLM, and GK designed the trial and oversaw the conduct of the trial, database design and development, site selection and training, data collection, data cleaning, and interpretation of results. AI did the statistical analysis. ALK, LF, SDP, KD, SLB, QEB, EH?, and CB are trial site principal investigators and enrolled participants, collected data, and prepared the manuscript. KA, PKA, SB, AE, EH, AJ, LR, FP, CT, AT, and SVE oversaw the implementation of the trial at sites or collected data, or both. SIR, HK, VSM, NPM, TH, TM, NM, CKM, PLM generated and analysed the data. SAM, GK, SCG, PLM, and AI prepared the manuscript. SAM and AI accessed and verified the data. All authors had full access to all of the data in the study and had final responsibility for the decision to submit for publication.