Ethical Issues
The present research involving human subjects was conducted following
the ethical standards of all applicable national (ICMR National
Bioethical Guidelines 2017) and institutional committees and the World
Medical Association’s Helsinki Declaration. It was conducted after
informed written consent from the participants and ethical approval from
the Institutional Ethical Committee of all the six centers of India
included in the study (IEC numbers: AIIMS/BBN/IEC/APR/2021/24;
AIIMS/MG//IEC/2022-23/198; IEC/AIIMS/KALYANI/2022/12;
IEC/Pharmac/2022/416; IHEC/AIIMS-GKP/BMR/111/2022;
IHEC-LOP/2022/EL043;).