Ethics approval and consent to participate
The Joint Research Ethics Committee of St James’s Hospital and Tallaght University Hospital has approved the current study (REC reference 307). This study is conducted in accordance with the Declaration of Helsinki. All participants are required to provide written informed consent by signing all study form(s), which are witnessed by an appropriately qualified and delegated member of the research team, prior to the completion of all study-specific procedures/ investigations. Participants would be re-contacted by telephone and postal mail for re-consent if any biological specimens are to be requested for use in further ancillary studies. Any protocol amendments will be approved by the appropriate research ethics committee.