The results described above are not typical. Clinical studies are underway to evaluate PROMETA® and to confirm reports from physicians using PROMETA in their practices. Only a PROMETA treating physician can determine if PROMETA is appropriate for any individual patient. The medications used in the PROMETA Treatment Program are Food and Drug Administration (FDA) approved for uses other than treating dependence on alcohol, cocaine, or methamphetamine. Therefore the risks and benefits of using those medications to treat dependence on those substances have not been evaluated by the FDA. Hythiam does not manufacture, distribute, or sell any medications, and has no relationship with any manufacturers or distributors of medications used in the PROMETA® Treatment Program.