Ethical considerations
ICH
DELHI
The study was approved by the Indian regulatory authority and the Institutional Ethics Committees (IECs) of each of the eight participating study sites. The IECs approving the study were Jamia Hamdard Institutional Ethics Committee, Delhi; Institutional Ethics Committee Bharati Vidyapeeth Deemed University, Pune; Ethics Committee Dr. D. Y. Patil Vidyapeeth, Pune; Institutional Ethics Committee-KIMS, Kalinga Institute of Medical Sciences, Bhubaneshwar; Noble Hospital Institutional Ethics Committee, Pune; Institutional Ethics Committee JSS Medical College, Mysuru; KEM Hospital Research Centre Ethics Committee, Pune; and Institutional Human Ethics Committee All India Institute of Medical Sciences, Gorakhpur. The study was conducted in compliance with Declaration of Helsinki (Revised Fortaleza, 2013) and the International Council for Harmonization (ICH) GCP Guideline, E6 R2 (2016).