In September 2013, the ‘window’ in which individuals could undergo their allocated trial procedure was extended from 24 to 72 h postrandomisation. End of trial The trial will end once 330 patients have been recruited and all patients have died or completed 6 months of trial follow-up (whichever is sooner). selleckchem 17-AAG Ethics and dissemination Monitoring An independent data monitoring

committee (IDMC) will be convened at regular intervals, consisting of members who are independent of the trial investigators. The role of the IDMC is to review study safety data and provide advice to the trial steering committee (TSC), specifically as to whether recruitment can continue. No interim analysis is planned. Safety reporting Data will be collected at each patient’s trial visit regarding any serious adverse events (SAE; as defined by GCP). All SAEs causally related to trial interventions will be reported to the sponsor and to the relevant oversight bodies, and will be followed until they resolve or stabilise. Trial monitoring and oversight The TSC will be responsible for overseeing the progress of the trial and will meet at approximate six monthly intervals. The TSC will comprise of independent chairperson, independent members, statistician,

patient and public representative and members of the trial team. Dissemination The trial will be publicised at regional and national conferences.

The final results will be presented at scientific meetings and published in a peer-reviewed journal (authorship will be according to the journal’s guidelines). In addition, a lay summary of the study results will be circulated to potentially interested parties. Supplementary Material Reviewer comments: Click here to view.(62K, pdf) Acknowledgments The authors are grateful for the infrastructure provided by the local Cancer Research Networks, and to all the trial teams involved in patient recruitment (see online supplementary appendix 1). Footnotes Contributors: NAM and NMR conceived the initial trial concept. All authors contributed to the development of the trial design and protocol. NMR and BCK carried out the sample size calculations. Anacetrapib RB, BCK, NMR, RFM and NAM wrote the statistical analysis plan. All authors have read and approved this manuscript. Funding: This trial is supported by The National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme; project number 10/50/42. Competing interests: None. Ethics approval: The trial and all substantial amendments have been reviewed and granted approval by the National Research Ethics Service (NRES) Committee North West—Preston (12/NW/0467). Provenance and peer review: Not commissioned; peer reviewed for ethical and funding approval prior to submission.