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Shruti Dharmadhikari, Prachi Ahire, Chintan Khandhedia, Neeraj Markandeywar, Amey Mane, and Suyog Mehta are employees of Sun Pharma. Prakadeesh Bharathi and Sadhna Joglekar were also employed by Sun Pharma during the study period. Prakadeesh Bharathi is not currently affiliated with any institution and declares no conflicts of interest relevant to the submitted work. Sadhna Joglekar is currently affiliated with Novartis. The views expressed in this article are her own and do not necessarily reflect the views or official position of Novartis.","order":1,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study was conducted in accordance with the approved protocol and adhered to applicable ethical, legal, and regulatory requirements, including the principles outlined in the Declaration of Helsinki (64th WMA General Assembly, 2013), International Council for Harmonisation Good Clinical Practice (ICH-GCP E6 R2), Indian GCP guidelines (CDSCO, 2004), New Drugs and Clinical Trials Rules (2019), and the Indian Council of Medical Research (ICMR) guidelines for biomedical research on human participants (2017). Ethics committee or institutional review board approvals were obtained independently from each participating site prior to study initiation. Details of the Ethics Committees\/Institutional Review Boards and their approval numbers are provided in the\n                      Supplementary File\n                      . Written informed consent was obtained from all participants before enrolment.","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}