I. The investigation is not intended to be reported to the FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug;

II. If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product;

III. The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increased the risk (or decreases the acceptability of the risks) associated with the use of the drug product;

IV. The investigation is conducted in compliance with the requirements for institutional review set forth in 21 CFR Part 56 and with the requirements for informed consent set forth in 21 CFR Part 50; and

V. The investigation is conducted in compliance with the requirements of 21 CFR Part 312.7.

All studies are expected to follow clinicaltrials.gov registration laws as specified by US Public Law 110-85, Title VIII, Section 801 (https://clinicaltrials.gov/ct2/manage-recs/fdaaa) and ICMJE requirements (http://www.icmje.org) for disclosure and publication of protocol and results.