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Article History

Received: 5 February 2018

Accepted: 17 May 2018

First Online: 5 June 2018

Ethics approval and consent to participate

: The study protocol (version 1.0) has been approved by the University of California, San Francisco Institutional Review Board (Study no: 16–19,162), Kenyan Medical Institute Scientific and Ethics Review Unit (SERU protocol no: KEMRI/SERU/CCR/0034/3251), and the Makerere University Higher Degrees, Research, and Ethics Committee (Protocol ID: IRB00011353). The protocol will be reviewed and reapproved on an annual basis and if protocol amendments are needed. Additional file InternalRef removed describes the SPIRIT recommended items to address in a clinical trial protocol. The trial is registered at ExternalRef removed, ID: NCT03112018. Consent procedures are described above in “Ethical considerations”; for 28-day follow-up among eligible newborns, mothers will be asked to provide written consent prior to discharge.

: PO and PW have no financial or non-financial competing interests to declare. DW is co-founder of PRONTO International.

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