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During the development of this work we presented our thinking at workshops and open meetings and would like to thank all participants for their valuable input and views: Society for Clinical Trials May 2013 Boston; Clinical Trials Methodology Conference Edinburgh November 2013; Royal Statistical Society October 2013; UK National Institute for Health Research (NIHR) Research Design Service London and South East March 2014 London; UK NIHR statisticians April 2015 London; Society for Academic Primary Care Annual Scientific Meeting July 2015 Oxford; HSRPP Health Services Research and Pharmacy Practice Conference April 2016. We also thank Colin Begg for feedback on the proposed items to be included in the guidelines during the two day consensus meeting in Oxford. Funding: We received grants from Queen Mary University of London (£7495), University of Sheffield (£8000), NIHR RDS London and South East (£2000), NIHR Statisticians Group (£2400), and Chief Scientist Office Scotland (£1000). CLC (nee Coleman) was funded by a National Institute for Health Research (NIHR) research methods fellowship. This article presents independent research partly funded by the NIHR. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Marion Campbell works at the Health Services Research Unit, University of Aberdeen, and the Unit receives core funding from the Scottish Government Health and Social Care Directorates; however, the opinions expressed are those of the authors alone. The funders had no role in this study. ; Peer reviewed ; Publisher PDF