Ethics & Regulatory Approvals

This study was approved by the Scotland A Research Ethics Committee (REC) (REC reference number: 13/SS/0136, amended REC REF AM01), and NHS Lothian Research & Development committee (Project Number: 2013/0098 and SA1). The study sponsor was the Academic and Clinical Central Office for Research and Development (ACCORD), a collaboration between the University of Edinburgh and NHS Lothian. Permission to access confidential medical records was granted by the NHS Lothian Caldicott Guardian. Written informed consent was obtained from all participants or their legal representative. Prior to commencing the study, a summary of the study protocol was registered in the public domain on the UK Clinical Trials Gateway (former UK Clinical Research Network) (registration number: 16116)²⁶. The study was conducted in accordance with the University of Edinburgh and NHS Lothian guidance. Adults without the capacity to give informed consent were recruited in accordance with the Adults with Incapacity (Scotland) Act 2000, Part 5²⁷. Informed consent was sought when capacity was regained.