A clinical trial is defined as any study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes..

Please note that these policies include the expectation that all manuscripts reporting clinical trials will include a copy of the original trial protocol, the complete statistical analysis plan and any amendments to protocol and/or plan.

Consistent with our policies, prospective clinical trial registration is required. Please state in the Methods section where the clinical trial registration information is publicly available. Satisfactory public databases include the NIH's http://www.clinicaltrials.gov and the site from the International Standard Randomized Controlled Trials at http://www.controlled-trials.com.

For all manuscripts that report clinical trials, CONSORT guidelines must be followed, including submission of a CONSORT flow diagram and checklist. If a subanalysis of a clinical trial is reported independently and it draws on the same population as the parent trial, the subanalysis can refer to the parent trial report in lieu of including the flow diagram and checklist. If however, the subanalysis reports on a subset of patients, a flow diagram and checklist are recommended.