Ethical approval was obtained from the Cross River State Ministry of Health (ref: CRS/MH/HREC/016/Vol.V/023) in May 2016.

The abstract of the protocol of this study was published on the website of the Funder (, therefore, the protocol was not registered before recruitment of the participants into the study. No changes were made to the protocol. There are no ongoing or related trials of this intervention. The trial is registered with the Pan African Clinical Trial registry (PACTR). Registration no: PACTR202008784222254.

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