Ethics approval
ICH
RECRUITMENT
The study was approved by the UK National Research Ethics Service (NRES) committee (South Central—Oxford A; REC 14/SC/1416). Written approval from local Research and Development (R&D) departments at each participating site was obtained before recruitment was commenced at each site.This study was conducted in accordance with the Declaration of Helsinki (1996), in full conformity with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines for Good Clinical Practice (CPMP/ICH/135/95 July 1996), the Research Governance Framework, and the Medicines for Human Use (Clinical Trial) Regulations 2004.