Wilby, Martin J.
Hopkins, Carolyn
Bedson, Emma
Howlin, Sue
Burnside, Girvan
Conroy, Elizabeth J.
Hughes, Dyfrig A.
Sharma, Manohar
Marson, Anthony
Clark, Simon R.
Williamson, Paula
Funding for this research was provided by:
Health Technology Assessment Programme (12/201/10)
Article History
Received: 21 March 2017
Accepted: 4 May 2018
First Online: 5 September 2018
Ethics approval and consent to participate
: This study is conducted in accordance with the principles of the Declaration of Helsinki, the Medicine for Human Use Regulations 2004 and Amendment Regulations 2006 and subsequent amendments, the Good Clinical Practice guidelines, and the Research Governance Framework for Health and Social Care 2005. Centralised full ethical approval was granted by the North West – Liverpool Central Research Ethics Committee (reference: 14/NW/1219) on 8 October 2014. Written informed consent will be obtained from all patients before recruitment by a trained researcher and patients are free to withdraw at any time. All data will be kept confidential and will be anonymised for analyses.
: The Patient Information Sheet and Consent Form (approved by the Research Ethics Committee) provides information that the results will be submitted for publication in a scientific journal and a final report written. Participants will not be identified in any reports or publications.
: The authors declare that they have no competing interests.
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