A study steering committee has been set up to provide overall supervision of the study on behalf of the study’s Sponsor and Funder and to ensure that it is being conducted in accordance with the rigorous standards set out in the Department of Health’s UK Policy Framework for Health and Social Care. The study steering committee will:  

• provide advice, through an independent Chairperson, to the study's funder, sponsor and principal and Co-Investigators on all aspects of the study  

• monitor the study's progress and adherence to the protocol   

• ensure the rights, safety and well-being of the participants are upheld   

• ensure appropriate ethical and other approvals are obtained in line with the project plan  

• agree proposals for substantial protocol amendments and provide advice to the sponsor and funder regarding approvals of such amendments