Authors’ contributions
DMN and BDS were responsible for the study’s rationale and generated the operating hypothesis for the study. DMN, PMB, ADS, MALS, LAG, NOC and BDS made major contributions for the protocol manuscript. DMN, KCM, PMB, ADS, MALS, LAG, NC and BDS contributed in intellectual, organizational and logistic frameworks for data collection, interventions’ rationale and implementation, allocation concealment, data assessors blinding and other important aspects of study workflow, together with critically reviewing the manuscript. All authors have read and approved the manuscript.