Competing interests: The BMJ has judged that the authors have no disqualifying financial ties to commercial companies that are relevant to this paper. The authors declare the following other interests: MK is an NHS employee (Consultant Physician) with a secondment in the GlaxoSmithKline (GSK) Research and Development Clinical Unit Cambridge (by 50%). MK also receives Consultancy fee from GSK and has a Consultancy agreement with Amarin Pharmaceuticals. SK is a trainee in Clinical Pharmacology and Therapeutics and is currently funded by UKRI-MRC Secondment Award (MR/W003538/1) to work part-time (50%) with AstraZeneca. MW conducts as a Lead Clinical Research Nurse Practitioner the ORION-4 study in the Cambridge University Hospitals, co-sponsored by the University of Oxford and Novartis.