Informed consent
Participants read or were read to the appropriate participant information and consent form (ICF) to acquaint themselves with what the current study entailed and what was required of them to participate. Both verbal and written informed consent was obtained from all participants in this study. This was documented on the ICF by the participant’s own signature, or thumbprint obtained from those not able to read or write in the presence of a competent independent witness. The witness also underwrote and signed on that participant’s behalf.