Written informed consent was obtained from all participants
prior to enrollment. The study was conducted in
compliancewith the ethical principles of theDeclaration ofHelsinkiandthe
InternationalConferenceonHarmonization guidelines
onGood Clinical Practice, and the protocol was approved
by the South AfricanMedicinesControl Council, thehumanresearch
ethicscommittee of Stellenbosch University, and the independent
review board of each center.