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Article History

Received: 6 February 2022

Accepted: 15 November 2022

First Online: 14 December 2022

Declarations

:

: This trial has been approved by the Melbourne Health Human Research Ethics Committee (HREC/62646/MH-2020), with initial approval given April 3, 2020. Additional ethics approvals have been given by Northern B Health and Disability Ethics Committee in New Zealand (20/NTB/75), Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC-2020-3713), Tasmania Health and Medical Human Research Ethics Committee (ref 21640), and the St John of God Health Care Human Research Ethics Committee (ref 1662). In India, ethics approval is given at each participating site with the initial approval given by the Institutional Ethics Committee, The George Institute for Global Health (Ref 13/2020). The current protocol is v5.0, approved 17 August 2021. The overall study sponsor is the University of Melbourne (). The sponsor has no role in the protocol design and study conduct and is not involved in decisions regarding release of study results.

: Not applicable.

: The authors declare that they have no competing interests.