Chatterjee, Sanjoy https://orcid.org/0000-0001-7402-8645
Chakraborty, Santam
Ahmed, Rosina
Agarwal, Sanjit Kumar
Arun, Indu
Sharma, Abhishek
Maulik, Shaurav
Mahajan, Shagun
Article History
Received: 7 September 2024
Accepted: 11 March 2026
First Online: 21 April 2026
Declarations
:
: Ethics approval has been obtained from the Institutional Review Board of Tata Medical Center, Kolkata. Version 1.0 of the protocol was approved on 23rd March 2024 vide approval number 2024/TMC/310/IRB814 and version 2.0 amendment was approved on 13th August 2024 vide. Approval number 2024/TMC/310/IRB814.All patients will be provided with a patient information leaflet which will detail the study purpose, procedures, harms and expected benefits. Written informed consent will be obtained and signed by an independent witness as well as the PI or Co-PI or designated authorised person(s) including trial nurses. The date, time and the name of the person obtaining the consent will be recorded in the medical records.
: The model consent form and patient information sheet for the trial is included as Appendix I. Publications from this study will not have identifying information related to patient and patient data will be reported in aggregate.
: The authors declare no competing interests.