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Participants have all the usual rights of an NHS patient.

The University of Oxford has arrangements in place to provide for harm arising from participation in the study.

In the unlikely event of anyone being harmed by taking part, insurance cover is provided by The Medicines Company. Any compensation would be paid in accordance with the guidelines of the Association of British Pharmaceutical Industry (ABPI).

If participants have concerns about any aspect of the study they can speak with the ORION-4  team by calling a 24-hour Freephone number: 0800 585323 (UK only). If they remain unhappy and wish to complain formally, they can do this through the NHS Complaints Procedure. They can get details from their hospital.