Received: 11 December 2020
Accepted: 12 April 2021
First Online: 3 May 2021
: The study was conducted in line with all relevant guidelines and regulations for the conduct of a randomised controlled trial. The underlying study design was approved by the funder (UK NIHR HTA programme) in the original funding application. The detailed study protocol was approved by the Trial Steering Committee (comprising an independent clinician who acted as chairperson, two further independent clinicians, an independent statistician, a lay representative and the Chief Investigator). In addition the economic evaluation reported in this paper complied with the CHEERS checklist for the reporting of an economic evaluation.
: The Newcastle upon Tyne Hospitals NHS Foundation Trust Research and Development Directorate sponsored the trial (Reference 6332). Favourable ethical opinion for the trial was obtained on 16th October 2012 from the NHS Research Ethics Service Committee North East—Newcastle and North Tyneside (Reference: 12/NE/0343) and subsequent Research and Development and Caldicott approvals were granted by each participating site.
: Study participants were consented at individual participating site following the procedure set out in the trail protocol. Trial information was provided and potential participants were given at least 48 h to consider participation in the study. Following review, at a mutually convenient time, those men who wanted to take part, who fulfilled the entry criteria and who understood the rationale and conduct of the trial, provided informed consent witnessed by research staff at site with delegated approval to do so. The right to refuse to participate without giving reasons was respected.
: Not applicable.
: All authors declare no competing interests.