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Article History

Received: 8 October 2025

Accepted: 11 December 2025

First Online: 23 January 2026

Declarations

:

: Deven Parmar is an employee of Zydus Therapeutics Inc., USA. Lokesh Bathula, Sandip Kirtane, Bhargav Darji, and Maulik Doshi are employees of Zydus Lifesciences Ltd. Mudit Bansal, Punit Singh, Ruchi K Mehta, Rohit Sanjay Laul, Parth Rana, Urmil Shah, Rajpal Vohra, Shachi Desai, Sharad Bhomaj, Sourabh Patwardhan, Jaishri Murli Manoher, Anjali Sapar, Sandeep Parwal, Ajay Kartik Amabde, Rahul Shroff, Sribhargava Natesh, Rupak Kanti Biswas, Lional Raj D, Bibhuti P Sinha, Minija C K, Ekta Patel, Ashish Kamble, Pramod Bhende, Sandeep Patil, Anup Shah, Ritesh Narula, and Bandana Kumari have nothing to disclose.

: The study protocol was duly approved by the institutional ethics committees (IECs) of the respective study sites and by the Central Drugs Standard Control Organization (CDSCO), in compliance with the New Drugs and Clinical Trials Rules, 2019. A detailed list of study sites along with their respective IECs is provided in the Supplementary Material. The study was conducted in accordance with the ethical principles of Declaration of Helsinki, Good Clinical Practice (GCP) guidelines of CDSCO, Ethical guidelines for Biomedical Research on Human Participants by the Indian Council of Medical Research (ICMR), and other relevant regulatory guidelines. Written informed consent was obtained from all participants prior to enrolment.