Monitoring
An internal monitor has been assigned to assess the study data and ensure that study procedures follow protocol and good clinical practice. As we are not investigating an invasive intervention and based on recommendations from the ethical boards, we decided not to have an independent data safety monitoring board and not to perform an interim analysis. This is also because there are no anticipated problems detrimental to the participant, but please include in the protocol. However, we will use an external monitor on an ad hoc basis provided by the reciprocal monitoring scheme of the East African Consortium of Clinical Research (EACCR). There are no further procedures and no auditing trial conduct.