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Article History

Received: 12 August 2024

Accepted: 21 November 2024

First Online: 22 February 2025

Declarations

:

: PA, BKJ, JS, SSB, VM, SKC and AB are full time employees of Dr Reddy’s Laboratories Ltd. The authors VK, MSV, MK, AK and OG are the trial investigators and they declared that no competing interests exist. The authors VK, MSV, MK, AK and OG entered into a contract for the patient recruitment and clinical conduct of the study at their respective sites.

: The study was conducted in compliance with the ethical principles that originate in the Declaration of Helsinki and the International Conference on Harmonization (ICH) guidelines for good clinical practice (GCP). The study was approved by institutional ethics committee of each participating centers. Written informed consent was obtained from each patient prior to screening on the approved informed consent form (ICF). Patients received a defined conveyance allowance in the study but were not compensated in other manner. All authors had access to all data and take full responsibility for the submission.

: The authors are solely responsible for the data and the contents of the paper. In no way, the Honorary Editor-in-Chief, Editorial Board Members, the Indian Society of Gastroenterology or the printer/publishers are responsible for the results/findings and content of this article