Assessment of drug tolerance and adverse drug reactions All women will be visited at home between Days 7 and 10 to look for any adverse events due to the study drugs. They will be advised to report to a health facility if they should experience any untoward effect of the drugs prior to, or after this home visit. The frequency and severity of spontaneous and elicited adverse events will be recorded. In the light of the information obtained, the association between the event and any of the study drugs will be judged as per the WHO guidelines52. All serious and adverse events will be reported to the DSMB immediately, and followed up with a written report which will fully document the event, and any available laboratory information or clinical data, will be included in the report.