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