Ethics approval and consent to participate
This study is approved by the East Midlands - Derby Research Ethics
Committee on 20th December 2013 with study number
13/EM/0398. All patients provided a written consent to participate in
the study. Clinical trial registration details: EudraCT number:
2013-003107-19; ISRCTN number: 98495886; Trail open date: 01/01/2014;
first recruitment date: 13/10/2014; URL:
http://www.isrctn.com/ISRCTN98495886