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Authors
Xavier, Arun M.
Varma R, Balagopal
K, Radhamany
Janakiram, Chandrashekar
King, Nigel
Alexander, Sherene
Rai, Kavita
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Funding
Funding for this research was provided by:
Grand-in-Aid scheme, Department of Health Research (DHR) of the Indian Council of Medical Research (R.11015/15/2023-GIA/HR, R.11015/15/2023-GIA/HR, R.11015/15/2023-GIA/HR, R.11015/15/2023-GIA/HR, R.11015/15/2023-GIA/HR, R.11015/15/2023-GIA/HR)
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Article History
Received: 24 August 2024
Accepted: 26 June 2025
First Online: 30 July 2025
Declarations
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: This trial will adhere to the principles outlined in the Declaration of Helsinki and the guidelines established by the Indian Council of Medical Research. The Principal Investigator will provide an Annual Progress Report throughout the clinical trial and a final report at its conclusion to the IRB at AIMS. The final data sets will never be accessed or handled by any unauthorized individuals.The study received ethics approval from the Institutional Ethics Review Committee, and any amendments to the study protocol will be conveyed to the ERC. The participants will be informed of the aim and methods of the study through videos and direct discussion with the principal investigator. A signed informed consent form that provides full study disclosures will be obtained from the participants at enrolment. The privacy and confidentiality of the participants will be strictly maintained during and after the trial phases. Participant information will be stored as the participant ID instead of personal information.
: The authors declare no competing interests.
