The Investigator will not deviate from the protocol without agreement from the Prof. A Collier (Chief Investigator), and REC and R&D approval, except if necessary to remove an apparent immediate hazard to the participant. In the event that this is necessary, the nature of and reasons for the deviation should be recorded. If this necessitates a subsequent protocol amendment this should be submitted in writing to the appropriate REC and Research and Development office for review and approval if appropriate.