The Editorial Board reserves the right to exercise judgment, which may be more stringent than that imposed by the investigator’s Institutional Review Board, regarding the ethics of a clinical trial involving investigational drugs. Compliance with the following conditions regarding investigational drugs must be stated in the first paragraph of the Methods section.

Studies that involve investigational drugs or devices must meet one of the following three criteria:

1. The drug or device is approved by the United States Food and Drug Administration (FDA) or equivalent regulatory agency in the country(s) in which the study took place.
2. The drug or device is not approved for this particular indication, but the drug or device is indeed widely used in this context as evidenced by publication in standard textbooks.
3. The study is being performed under an Investigational New Drug (IND) application approved by (or waived by) the FDA or equivalent regulatory agency.

In the absence of an approved or waived IND, investigators may be expected to provide upon request the following information as part of the manuscript submission process:

1. Copies of the Institutional Review Board or Research Ethics Committee application and approval letter.
2. A copy of the informed consent document that patients were requested to sign.
3. Discussion as to why the off-label use of the studied drug or device is justified. What unique advantage(s) its use presents over existing ones that might supersede the potential risks.
4. Reference to and discussion of existing animal and human safety information related to the drug or device.
5. All claims as to the drug’s safety must be clearly presented in terms of the conditions under which they were studied and accompanied by statistical expressions of potential harm, such as an upper limit of a 95% confidence interval.

The Editorial Board reserves the right to require supplemental information, not limited to that described above, prior to review of or acceptance of the manuscript.