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ng date 27 January 2021 Trial duration 6 months TRIAL REGISTRATION The trial has been prospectively registered in Clinical Trial Registry - India (ICMR- NIMS) Reference no. CTRI/2020/07/026791 (registered on 25 July 202]. The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The full protocol is attach