Institutional Review Board Statement
The study protocol, all amendments, and the informed consent form were reviewed and approved by the Independent Ethics Committee/Institutional Review Boards of all 10 study hospitals (list of hospitals in author list). Independent Ethics Committee/Institutional Review Boards of Institutional Ethics Committee for Ajanta Hospital & IVF Centre (ECR/611/Inst/UP/2014), Institute of Child Health (ECR/359/Inst/WB/2013), Theresa’s Hospital (ECR/230/Inst/AP/2013/RR-19), Institutional Ethics Committee Praveen Cardiac Centre (ECR/336/Inst/AP/2013), Noble Hospital Institutional Ethics Committee, Sterling Hospital Institutional Ethics Committee (ECR/259/Inst/MH/2013/RR-19), Sangini Hospital Ethics Committee (ECR/542/Inst/MH/2014/RR-20), Ethics Committee Jehangir Clinical Development Centre Pvt. Ltd. (ECR/147/Inst/GJ/2013/RR-16), Penta-Med Ethics Committee (ECR/352/Inst/MH/2013), JSS Medical College & Hospital Institutional Ethics Committee (ECR/357/Inst/MH/2013/RR-20). The study was performed in accordance with the protocol, Good Clinical Practice (GCP) guidelines [