To be considered for peer review, randomized clinical trials (RCTs) must have been registered before enrollment of the first participant. This requirement applies to pilot and full-scale RCTs. Registration is also required for consideration of brief reports describing protocols for full-scale RCTs. Reports of findings from unregistered clinical trials will be returned and will not be peer reviewed. Trials should be registered on acceptable databases listed at one of these sites:
For more information, see ICMJE/Clinical Trial Registration at: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
Include the registry and trial number on the title page of the manuscript and in response to the Author Questionnaire item about clinical trial registration. (Corresponding authors receive the questionnaire when uploading a submission.) For questions, please contact Susan J. Henly, Editor: firstname.lastname@example.org.