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Authors
Singh, Awadhesh Kumar
Das, Ashok Kumar
Murthy, L. Sreenivasa
Ghosal, Samit
Sahay, Rakesh
Harikumar, K. V. S.
Keshava, Ganesh Hosahithlu
Agarwal, Mayur
Vijayakumar, G.
Kalra, Pramila
Lodha, Piyush
Das, Sambit
Shaikh, Shehla
Goswami, Soumik
Ajish, T. P.
Kumthekar, Prashant
Upadhyay, Mihir
Thamburaj, Anthuvan
Mahule, Aushili
Prasad, Ashish
Pednekar, Abhijit
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Funding
Funding for this research was provided by:
Exemed group, Gujarat, India
USV Private Limited
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Article History
Received: 6 August 2024
Accepted: 14 October 2024
First Online: 5 December 2024
Declarations
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: Dr Aushili Mahule, Dr Ashish Prasad, Dr Abhijit Pednekar & Dr Anthuvan Thamburaj are the employees of USV Private Limited. Awadhesh Kumar Singh, Ashok Kumar Das, L Sreenivas Murthy, Samit Ghosal, Rakesh Sahay, KVS Hari Kumar, Ganesh Hosahithlu Keshava, Mayur Agarwal, G Vijayakumar, Pramila Kalra, Piyush Lodha, Sambit Das, Shehla Shaikh, Soumik Goswami, T.P Ajish, Prashant Kumthekar, Mihir Upadhyay have no nothing to disclose. The sponsors of the project were the manufacturers of the marketed product of drugs used in this study.
: The study was conducted, monitored, evaluated, and audited to comply with the International Conference on Harmonization Good Clinical Practice guidelines. The study was conducted in accordance with the ethical guidelines for biomedical research on human patients by the Indian Council of Medical Research, ethical principles of the Declaration of Helsinki, and New Drugs and Clinical Trials Rules 2019. The study also received the institutional ethics committee approval at each of the 12 study sites (Supplementary material; Table ). The master ethics approval was obtained from Institutional Ethics Committee, Maharaja Agrasen Superspecialty Hospital (IEC/APV/JAN/2022/07). Informed written consent was obtained from all the study participants.
