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New therapies, including medications, medical devices and surgical procedures, are evaluated in research studies known as clinical trials. Often these new therapies are investigational, which means they are not yet approved by the U.S. Food and Drug Administration for general use. However participation in clinical trials offers the potential for new treatment options and allows patients to participate with researchers in driving the discovery of effective therapies. There are always risks involved, some known and possibly some that are unknowns, and patients should consult with their physicians in considering the appropriateness of a clinical trial for their particular situation. Clinical trials are done under the supervision of the FDA.