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Article History

Accepted: 8 April 2025

First Online: 27 May 2025

Declarations

:

: All the authors wish to acknowledge Synergen Bio Private Ltd for CRO support for the study.

: This research was conducted collaboratively by all authors. The study design, statistical analysis, and protocol writing were undertaken collectively by all the authors. All the authors oversaw the study analyses, managed literature searches, and contributed to the initial draft of the manuscript. All authors have read and agreed to the published version of the manuscript.

: This study was funded by Glenmark Pharmaceuticals Ltd, India.

: The data presented in this study are available on request from the corresponding author.

: All authors are employees of Glenmark Pharmaceutical Ltd.

: The study was conducted as per the ICMR Ethical Guidelines for Biomedical Research on Human Subjects, ICH-GCP Guidelines and in accordance with the Declaration of Helsinki and G.S.R. 227(E) New Drugs and Clinical Trials Rules, 2019 and Guidelines for Bioavailability and Bioequivalence Studies, Central Drugs Standard Control Organization, March 2005. Ethical approval IECSSHl 70123 was received on 17 th Jan 2023 from the Institutional Ethics Committee (Sai Sneh hospital and diagnostic centre, Pune, India).

: Informed consent was obtained from all the particpants enrolled in the study.

: Informed consent was obtained from all the patients involved in the study.