Funding for this research was provided by:
Health Technology Assessment Programme (13/115/62)
Article History
Received: 18 December 2018
Accepted: 24 April 2019
First Online: 30 May 2019
Ethics approval and consent to participate
: The National Research Ethic Committee approved this study on 18 March 2016 (reference 16/SC/0109). This study has been registered on the International Standard Randomised Controlled Trial Number Registry with reference number ISRCTN62639639.Informed consent from the patient has been obtained by an appropriately trained and delegated member of the research team. Patients have been provided with verbal and written information about the study. Patients willing to participate have been asked to complete an informed consent form. Any new information that arises during the trial that may affect participants’ willingness to take part will be reviewed by the Trial Steering Committee; if necessary, this will be communicated to all participants. A revised consent form will be completed if necessary. Patients have been asked to consent to long-term follow up and data linkage to routine National Health System and Social Care datasets.
: Not applicable.
: MLC is a member of the UK NIHR HTA General Board.
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