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Article History

Received: 23 September 2025

Accepted: 17 February 2026

First Online: 1 March 2026

Declarations

:

: The study was entirely funded by Sun Pharma Laboratories Limited. Authors Chirag Gupta, Avinash TS, Dushyant Shamlabhai Pawar, Abhay Khandekar, G. Ravindra Deshmukh, Vinay Kumar, Ajwani Vikky Ramesh, Shah Ishan Hemantkumar, and Patankar Suresh Balkrishna were the study investigators, and they have received a grant from the sponsor for conducting the study at their respective sites. Authors Dipesh Sonawane, Dipak Patil, Pravin Ghadge, and Suyog Mehta are full-time employees of Sun Pharma Laboratories Limited. Author Mandodari Rajurkar was a full-time employee of Sun Pharma Laboratories Limited during the conduct of the study and interpretation of the study data.

: Written informed consent was obtained from all participants prior to screening for the study.

: The study was reviewed and approved by the Institutional Ethics Committees at all participating study sites. These included Institutional Ethics Committee Jaipur National University Institute for Medical Science & Research Center, Institutional Ethics Committee Sparsh Hospital, Parth Hospital Ethics Committee, Riddhi Medical Nursing Home Institution Ethics Committee, Jasleen Hospital Ethics Committee, Ethics Committee GSVM Medical College, Anand Institutional Ethics Committee, Institutional Ethics Committee Dr. M. K. Shah Medical College and Research Center, and AMAI Trust Ace Hospital.