AUTHOR CONTRIBUTIONS Contribution: K.B.B.P., principal investigator of this trial, conceived and designed the study; E.V.D.P., M.T.D. and G.O.D. were sub-investigators. KBBP and EVDP contributed to the data interpretation and drafted… Click to show full abstract
AUTHOR CONTRIBUTIONS Contribution: K.B.B.P., principal investigator of this trial, conceived and designed the study; E.V.D.P., M.T.D. and G.O.D. were sub-investigators. KBBP and EVDP contributed to the data interpretation and drafted the manuscript. K.B.B.P., E.V.D.P., A.B.P.L., E.C.M., C.D.S. contributed to critical review and revision of the manuscript. ECM made the statistical analysis. A.B.P.L., M.T.D., G.O.D., J.V., M.A.S.S. participated in the site work, including the recruitment, follow-up, and data collection. A.B.P.L., B.R.V.R., V.M.O.P. and G.C.P.F. performed laboratory analyses. All authors approved the final version of the final manuscript and were responsible for the decision to submit for publication.
               
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