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Article History

Received: 17 May 2021

Accepted: 18 August 2022

First Online: 6 September 2022

Declarations

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: Ethical approval was obtained from the Institutional Review Board in each participating country and at each research location before the start of the study. Information sheets and consent forms were made available in the major South Asian languages. Multilingual translators were available as required. Each participant provided informed consent. People unwilling or unable to provide consent were excluded from the study.<i>India</i>• Max Healthcare Institutional Ethic Committee (ref: CT/MSSH/SKT-2/ENDO/IEC/14–40, date 22/04/16).• Indian Council for Medical Research (ICMR, ref: 55/7/Indo-Foreign-Diab/2014-NCD-II, date 08/02/2016).<i>Pakistan</i>• Punjab Institute of Cardiology Ethical Committee (ref: rtpgme-research-047, date 09/04/16).• Services Institute of Medical Sciences Institutional Review Board (ref: IRB/2016/222/SIMS, date 12/03/16).<i>Sri Lanka</i>• University of Colombo Ethics Review Committee (ref: EC-16–063, date 23/05/16).• University of Kelaniya Ethics Review Committee (ref: P/62/05/2016, date 11/05/16).<i>UK</i>• West Midlands—Solihull Research Ethics Committee (ref: 16/WM/0171, date 14/04/2016).<i>Trial registration</i>• EudraCT 2016–001350-18. Registered on 14 April 2016• ClinicalTrials.gov NCT02949739. Registered on 31 October 2016,, First posted 31/10/2016.

: Not applicable, no datasets are included in this SAP.

: The authors declare that they have no competing interests.