Ethics approval and consent to participate {24}
IRD
The RCT has approval from each individual site in India, Pakistan, and an exemption letter from the UK. Written, informed consent will be obtained from all participants at each site.• Institutional Ethics Committee of SCARF (India)• Queen Mary Ethics of Research Committee (UK)• IRD’s Independent Institutional Review Board (IRD_IRB_2021_01_005) (Pakistan)• Karwan-e-Hayat Management Committee (Institutional Approval) (Pakistan)• Jinnah Postgraduate Medical Centre Research Committee (NO.F.2-81/2021-GENL/60224/JPMC) (Pakistan)• Aga Khan’s Ethics Research Committee (2021-5933-17533) (Pakistan)• National BioEthics Committee, Pakistan (NBC-774) (Pakistan)