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Time to recognize three classes of non-inferiority trial margins

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Footnotes

  • Contributors JLS wrote the first draft. EM provided critical draft revision comments.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests JLS: Medtronic, Cerenovus, Boehringer Ingelheim (prevention only): contracted hourly payments for clinical trial steering committee service advising on rigorous study design and conduct; Rapid Medical: contracted stock option for clinical trial steering committee service advising on rigorous study design and conduct; MIVI, Occlutech: contracted hourly payments for data and safety monitoring board service. EM: NIH-NINDS: grant; American Heart Association/American Stroke Association: payment for editorial activities; Clinical Neurological Society of America: Scientific Planning Committee.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.