 9. Clinically significant abnormalities of hematology or biochemistry as confirmed by repeat testing based on investigators discretion, including but not limited to, elevations greater than 2 times the upper limit of normal of Aspartate Aminotransferase AST, Alanine Aminotransferase ALT, Alkaline Phosphatase ALP or creatinine clearance less than 60 mlmin at screening via estimated Cockcroft-Gault formula: 