2.3. Ethics and study design
The trial was conducted as a prospective, randomized, double-blind, placebo-controlled at 2 investigative sites in Bangalore (MS Ramaiah Medical College and Hospitals and Santosh Hospital) between August 2019 and March 2021. The Institutional Ethics Committees of both sites approved the study. Written informed consent was taken from all the subjects before enrollment in the study. The trial was conducted per the Declaration of Helsinki, the International Conference on Harmonization Guidelines for Good Clinical Practice, and applicable local regulations and was registered prospectively with the clinical trial registry of India with the registration number clinical trial registry of India/2019/06/019617.