 9. Neutrophil count 1,500mm3, platelets 100,000mm3, serum creatinine 1.5 x upper limit of normal ULN, total bilirubin 1.5 x ULN, alanine aminotransferase ALT 3 x ULN, aspartate aminotransferase AST 3 x ULN, or INR 1.2 at Screening evaluations; 