Ethics approval and consent to participate
The trial was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. The protocol was approved by the independent ethics committees (IECs) and institutional review boards of the participating centres The IEC (National Research Ethics Service Committee London – Chelsea Research Ethics Committee Bristol Centre, Bristol, United Kingdom) of the Coordinating Investigator gave a favourable opinion for the study on 14 August 2014. All patients provided written informed consent.