Ethics
HEART
The MOLI study was approved by the Institutional Ethics Committees at Government Medical College Nagpur (1724 EC/Pharmac/GMC/NGP), Spandan Heart Institute and Research Center, Mahatma Gandhi Institute of Medical Sciences (MGIMS/IEC/OBGY/96/2020) and Liverpool (Ref. 4691). The qMOLI study (NCT04037683) was approved by the Research Ethics Committees in Nagpur and Liverpool (Ref. 1756). This trial is sponsored by the University of Liverpool (UoL001374). The study is registered with Clinical Trials.gov (NCT03749902) and Clinical Trial Registry, India (CTRI/2O W I A4l 0 I 8527).