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Article History

Received: 27 July 2022

Accepted: 30 November 2022

First Online: 23 December 2022

Declarations

:

: The study complies with the Declaration of Helsinki, ICH-GCP, and Ethical guidelines for biomedical research on human participants 2006, issued by the Indian Council of Medical Research, India. The ACEAS-Independent Ethics Committee, Ahmedabad, India (CDSCO Reg. No. ECR/281/Indt/GJ/2017/RR-21; dated February 04, 2021, and OHRP & DHHS IRB No. IRB00011046; IORG No.: IORG0009271; dated May 09, 2022) approved and monitored the study (Protocol approval ID: JHB/190702/NATIVECTII/OA; dated March 21, 2020) for Mumbai site and the Shubham Sadbhawana Hospital Ethics Committee, Varanasi (Reg. No.: ECR/667/lnst/UP/2014/RR-20; dated December 30, 2020) approved and monitored the study at the Varanasi site (Protocol approval ID: JHB/190702/NATIVECTII/OA; dated October 08, 2020). All the participants provided written informed consent before enrollment in the study.

: Not applicable.

: CL is affiliated with Jiaxing Hengjie Biopharmaceutical Co. Ltd., Zhejiang, China. The other authors declared that they have no competing interests.