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Authors
Jain, Aditi https://orcid.org/0009-0007-2617-2512
Vispute, Abhay
Dange, Amol
Naskar, Arindam
Mondal, Asish
Vivekanand, B.
Sharma, Balram
Varade, Deepak
Shukla, Dhaiwat
Bhatia, Girish
Chaudhari, Harshal
Ram Babu, K.
Gavali, Onkar
Sorate, Sanket
Bhanushali, Shaishav
Kothari, Vaibhav
Khandelwal, Vipul
Sharma, Akhilesh
Pawar, Roshan
Mayabhate, Mayur
Shahavi, Vinayaka
Rajput, Aashishsingh
Jaiswal, Mukesh
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Article History
Received: 29 September 2023
Accepted: 23 October 2023
First Online: 14 November 2023
Declarations
:
: Aditi Jain, Dr. Abhay Vispute, Dr. Amol Dange, Dr. Arindam Naskar, Dr. Asish Mondal, Dr. B. Vivekanand, Dr. Balram Sharma, Dr. Deepak Varade, Dr. Dhaiwat Shukla, Dr. Girish Bhatia, Dr. Harshal Chaudhari, Dr. K. Ram Babu, Dr. Onkar Gavali, Dr. Sanket Sorate, Dr. Shaishav Bhanushali, Dr. Vaibhav Kothari, Dr. Vipul Khandelwal, Dr. Akhilesh Sharma, Dr. Roshan Pawar, Dr. Mayur Mayabhate, Dr. Vinayaka Shahavi, Dr. Aashishsingh Rajput, and Mukesh Jaiswal have no competing interests. The authors have no financial or non-financial interest to declare. No funding was received for the preparation of this manuscript.
: The study was in compliance with ICH‐GCP guidelines and the NDCT Rule 2019 (India). It was approved by the ethics committee of all the 16 trial sites across India, that is, lnstitutional Ethics Committee Apex Hospitals, Pvt (ECR/380/Inst/RJ/2013/RR-19), Penta-Med Ethics Committee (ECR/357/Inst/MH/2013/RR-20), LPR Ethics Committee (ECR/751/Inst/MH/2015/RR-21), Shree Siddhivinayak Hospital Ethics Committee (ECR/1247/Inst/MH/2019), Ethics Committee of Trauma Care Hospital ECR/1623/Inst/MH/2021), Shrey Hospital Institutional Ethics Committee (ECR/1302/Inst/GJ/2019), Institutional Ethics Committee for Human Research Medical College and Hospital (ECR/287Inst/WB/2013/RR-19), Institutional Human Ethics Committee, Panimalar Medical College & Research Institute (ECR/1399/Inst/TN/2020), Sangini Hospital Ethics Committee (ECR/147/Inst/GJ/2013/RR-19), Institutional Ethics Committee Amrita Institute of Medical Sciences (ECR/129/Inst/KL/2013/RR-19), Ethics Committee of SMS Medical College and Attached Hospital (ECR/26/Inst/RJ/2013/RR-19), Institutional Ethics Committee Osmania Medical College (ECR/300/Inst/AP/2013/RR-19), Shree Siddhivinayak Maternity and Nursing Home Unity Campus (ECR/1247/Inst/MH/2019), Clinical Research Ethics Committee (ECR/194/Inst/WB/2013/RR-20), Institutional Ethics Committee, Meenakshi Mission Hospital and Research Centre (ECR/398/Inst/TN/2013/RR-19), and Help Hospitals Pvt. Ltd (ECR/1356/Inst/AP/2020). The study involves human subjects and informed consent was obtained from all 232 patients involved in the study. Consent to publication is not applicable to this article.
