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This report provides a framework for best practice for those considering the use of a placebo control in a surgical randomised controlled trial.
1 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
2 Health Services Research Unit, University of Aberdeen, Aberdeen, UK
3 Centre for Surgical Research, NIHR Bristol and Weston Biomedical Research Centre, Population Health Sciences, University of Bristol, Bristol, UK
4 Departments of Medicine, Epidemiology and Biostatistics, and Philosophy, Western University, London, ON, Canada
5 Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada
6 Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia
7 Academic Department of Surgery, University of Birmingham, Queen Elizabeth Hospital Birmingham, Birmingham, UK
8 Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK
9 The Oxford Uehiro Centre for Practical Ethics, University of Oxford, Oxford, UK
10 Faculty of Medicine, South Western Sydney Clinical School, University of New South Wales, Sydney, NSW, Australia
11 Department of Clinical Sciences Lund, Orthopedics, Clinical Epidemiology Unit, Lund University, Lund, Sweden
12 Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany
13 Patient representative, Oxford, UK
14 Wessex Institute, University of Southampton, University Hospital Southampton NHS Foundation Trust, Southampton, UK
15 Department of Health Sciences, University of York, York, UK
16 Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford, UK
17 Birmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
18 Faculty of Medicine and Health, Institute of Bone and Joint Research, Northern Clinical School, The University of Sydney, Sydney, NSW, Australia
19 School of Health and Related Research, University of Sheffield, Sheffield, UK
20 Clinical Trials Evaluation Unit Bristol Medical School, University of Bristol, Bristol Royal Infirmary, Bristol, UK
21 Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Oxford, UK
22 Medical Research Council, London, UK
23 Editorial Department, The Lancet, London, UK
* Corresponding author Email: david.beard@ndorms.ox.ac.uk
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