Ethical considerations
MAY
The study was approved by the Institutional Ethics Committee of It was retrospectively registered with the Pan African Clinical Trials Registry (PACTR201908520097051) on 18 July 2019 due to technical difficulties. At the time of IEC approval, the trial registry was not available due to maintenance and connection issues. In order to meet both the requirement to make study information transparently available and logistical constraints to start recruiting, the study was registered in MESA Track on 28 May 2019