 19. Subject has abnormal hepatic function tests aspartate aminotransferase AST, alanine aminotransferase ALT, bilirubin or renal function estimated creatinine clearance CrCl 95 mLmin for males and 85 mLmin for females based on serum creatinine using Modification of Diet in Renal Disease MDRD-glomerular filtration rate GFR method at screening. 