Title 1 Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym ______1_______ Trial registration 2a Trial identifier and registry name. If not yet registered, name of intended registry ______1_______ 2b All items from the World Health Organization Trial Registration Data Set _Not applicable_ Protocol version 3 Date and version identifier _____1 & 4______ Funding 4 Sources and types of financial, material, and other support ___11______ Roles and responsibilities 5a Names, affiliations, and roles of protocol contributors _____10,11___ 5b Name and contact information for the trial sponsor _Not applicable__ 5c Role of study sponsor and funders, if any, in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication, including whether they will have ultimate authority over any of these activities ____10,11____ 5d Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint adjudication committee, data management team, and other individuals or groups overseeing the trial, if applicable (see Item 21a for data monitoring committee)