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Article History

Received: 6 March 2020

Accepted: 6 January 2021

First Online: 25 January 2021

Ethics approval and consent to participate

: The parent trial and validation substudy were approved by the Johns Hopkins Bloomberg School of Public Health Institutional Review Board in Baltimore, USA. In Nepal, approval was received from the Tribhuvan University Institute of Medicine, Kathmandu (parent trial) and the Nepal Health Research Council, Kathmandu (substudy). Women under the age of 16 were included in the study if married and provided their own consent in line with Nepal IRB rules. Staff obtained written consent from all participants.

: Not applicable.

: All authors have completed the ICMJE uniform disclosure form at (available upon request from the corresponding author). Dr. Carter reports grants from Bill & Melinda Gates Foundation, during the conduct of the study. Dr. Chang reports grants from Bill & Melinda Gates Foundation, during the conduct of the study. Dr. Mullany reports grants from Bill & Melinda Gates Foundation, during the conduct of the study; grants from NIH, grants from TRAction / USAID, grants from Bill & Melinda Gates Foundation, outside the submitted work. Dr. Khatry and Mr. LeClerq have nothing to disclose. Dr. Munos reports grants from Bill & Melinda Gates Foundation, during the conduct of the study; grants from Bill & Melinda Gates Foundation, grants from Global Affairs Canada, outside the submitted work. Dr. Katz reports grants from Bill and Melinda Gates Foundation, during the conduct of the study; grants from NIH, grants from Thrasher Fund, grants from Whole New World Foundation, grants from USAID, outside the submitted work.