Authors reporting experimental studies on human subjects must include a statement of assurance in the Materials and Methods section of the manuscript reading that: (a) informed consent was obtained from each patient included in the study and (b) the study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in a priori approval by the institution's human research committee.

In studies involving animal experimentation, provide assurance that all animals received humane care according to the criteria outlined in the "Guide for the Care and Use of Laboratory Animals" prepared by the National Academy of Sciences and published by the National Institutes of Health (NIH publication 86-23 revised 1985).