Author Contributions: Dr Piaggio had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Piaggio, Elbourne, Pocock, Evans, Altman.
Acquisition of data: Piaggio, Elbourne, Altman.
Analysis and interpretation of data: Piaggio, Elbourne, Altman.
Drafting of the manuscript: Piaggio, Elbourne, Pocock, Altman.
Critical revision of the manuscript for important intellectual content: Piaggio, Pocock, Evans, Altman.
Obtained funding: Altman.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: The CONSORT Group receives funding from the UK Medical Research Council. Dr Piaggio and Dr Elbourne received a small contribution from the CONSORT group toward the time spent on this and other CONSORT work. Dr Piaggio was supported by the CONSORT group to attend meetings in London. Dr Altman is supported by a Cancer Research UK programme grant (C5529).
Role of the Sponsors: The study sponsors had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript.
Additional Contributions: We thank the members of the CONSORT Group for comments on earlier drafts. This group endorsed the submission for publication.