Ethical Approval
EVENT
The Institutional Review Boards (IRB) of UCLA (IRB no.14–001587) and Stellenbosch University (N14/08/116) approved the current study protocol (Version 3.0, 1 June 2018; clinicaltrials.gov # NCT02358226). The IRBs approved any changes to the study protocol, and the Clinical Trials registration was updated in the event of protocol modifications.