Ethics
DELHI
The trial was conducted according to the guidelines outlined in the Declaration of Helsinki. It was approved by the ethics committees of the Society for Applied Studies, New Delhi (SAS/ERC/LG/2017); Vardhman Mahavir Medical College and Safdarjung Hospital (IEC/SJH/VMMC/PROJECT-2017/694), New Delhi; and WHO, Geneva (ERC.0002934).Prior to enrolment a written individual informed consent in the local language was obtained from participants. The form was read aloud for those who couldn’t read, and a thumb imprint was taken as witnessed by an impartial literate witness for those who couldn’t sign.