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Article History

Received: 29 June 2022

Accepted: 24 August 2022

First Online: 8 September 2022

Declarations

:

: Ethical approval has been obtained from the Health Research and Ethics Committees of the Lagos University Teaching Hospital (ADM/DCST/HREC/APP/3971), Lagos State Health Service Commissions (LSHSC/2222/VOLIII), Lagos State Primary Health Care Board (LS/PHCB/MS/1128/VOL.VII/100), Aminu Kano Teaching Hospital, Kano (NHREC/28/01/2020/AKTH/EC/2955), Ministry of Health, Kano State (MOH/Off/797/T.1/2102), and National Health Research and Ethics Committee (NHREC/01/01/2007- 17/01/2021), all in Nigeria. We also have approval from the National Agency for Food and Drug Administration and Control (NAFDAC/DER/VCTD/IVON/VOL.2 OF 23/04/2021).Written consent for participation will be obtained from all eligible women before study enrolment. Pregnant women aged 15 to less than 18 years of age will be considered able to provide independent consent, according to National Health Research Ethics Committee guidelines []. This is due to their classification as emancipated minors for the purpose of this study, considering the 2016 World Health Organization’s International Ethical Guidelines for Health-related Research Involving Humans [].All amendments to the protocol will be submitted to the ethics committees for approval before implementation. The drug regulatory body will also be notified. The revised protocol will be circulated to various study sites for all research team members to study properly and implement. If there is a need for additional training on the revised content, this will be done before implementation. Information will be updated in the clinical trial registries according to the changes made in the latest protocol version.

: All authors gave consent for this protocol to be published.

: The authors declare that they have no competing interests.