10. Subjects with evidence of impaired liver/kidney function upon entry into the study defined as: Aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels >3 times the upper limit of normal; Gamma glutamyl transpeptidase ≥5 times the upper limit of normal; Total bilirubin level outside of the reference range unless the value is associated with pre documented Gilbert's Syndrome; Creatinine level outside of the reference range or > 2 mg/dl unless after discussion with the Medical Monitor it is confirmed the subject does not have renal impairment that would preclude the subject's inclusion in the study; In the investigator's opinion the subject has liver and/or kidney impairment to the extent that the subject should not participate in this study.