Participant's contact details (cellular phone number, address, etc), these will only be available to name senior research staff involved in the study. Details will not be shared with the clinic staff or with any other service provider unless permission to do so is expressly given by the participant once the study has concluded. Data will be captured using a combination of electronic data capture and paper case-report forms (CRFs). CRFs will be entered onto the trial database on the day of collection. The trial database will include checks for logic and consistency to be resolved by the local investigators. Data will be stored on a computer with individually assigned passwords and individually assigned levels of access. The trial database will include a full audit trail of any changes made. Randomisation codes will be separately stored and accessible only by the trial statistician. No personal data will be included in the trial database and participants will be identifiable only by a unique study number. All essential documents will be retained in a trial master file. Trial documentation will be archived and stored for seven years.