2.2. Study design and ethics
A randomized, double-blind, placebo-controlled study was conducted from September 2020 to November 2021 at Narayana Institute of Cardiac Sciences, Bangalore, and Vijaya Super Specialty Hospital, Nellore, in India. The study was initiated only after receiving approval from the independent ethics committee of both the hospitals for Protocol No. CPL/83/ASH_STRS/I/AUG/19, V3.0,05-FEB-21. The study was conducted following Good Clinical Practice as required by the International Conference on Harmonization. The trial was registered prospectively with the Clinical Trial Registry of India (CTRI) with the registration number CTRI/2020/02/023321 on 13/02/2020.