4. Clinically significant abnormality in liver function, renal function, chemistry panel or CBC (AST or ALT ≥ 2 times the laboratory's upper limit of normal, hemoglobin < 10.0 g/dL, platelet count <125,000/cm3, white blood count <3,500 cells/cm3 or > 15,000 cells/cm3, or serum creatinine ≥ 1.5 mg/dL) within two weeks of the baseline visit.