Ethics approval and consent to participate
The trial was approved by the National Research Ethics Service Committee: London – Bloomsbury (12/LO/1822), the Medicines and Healthcare Products Regulatory Agency (Clinical Trials Authorisation number 20363/0315/0014-0001), and by the Research and Development department of each participating NHS Trust. The trial was conducted according to the principles of the International Conference on Harmonisation on Good Clinical Practice. All patients gave written informed consent prior to undergoing any trial-specific procedures.