 Safety reporting will be from baseline to the 26 week follow up visit. Adverse events may be recorded by the participant using the trial telephone number, email, or via the text message service or smart phone app. Participants will be directly asked about adverse events at each study visit. All serious adverse events, whether expected or unexpected, need to be reported. All serious adverse event SAE information will be recorded on the Primary Care Clinical Trials Unit PC-CTU SAE report form by the site or the Chief Investigator CI and faxed to the PC-CTU dedicated fax line. SAEs will be reported to the PC-CTU as soon as possible, preferably within 24 hours. The PC-CTU will perform an initial check of the report, request any additional information from the reporting clinician and ensure that the CI or safety delegator reviews and evaluates the report for expectedness and relatedness. All SAE reports will also be reviewed routinely by the Independent Safety Review Committee. All SAEs will be followed up until resolution or the end of the study period. 