Statement of Ethics
WEST
Ethical approval for up to 2-year post-randomisation assessment was received by East of England Cambridge East and local approvals from the NRES Committee North West Liverpool Central and the NRES Committee South Central Oxford. Ethical approval for 5-years post-randomisation assessment was received from West Midlands-Coventry and Warwickshire Research Ethics Committee on December 8, 2017. The original trial (ISRCTN82857232) and 5-year follow-up (ISRCTN64986150) were prospectively registered with Current Controlled Trials on October 15, 2012, and February 01, 2018 (