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e key elements of the full protocol. Protocol version1.0 Recruitment start June 3rd, 2020 (Ongoing) Recruitment finish (expected) October 31st, 2020 TRIAL REGISTRATION Clinical Trial Registry of India (CTRI) CTRI/2020/06/025575 . Registration on 03 June 2020 FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of t