7. Clinically important abnormalities in the physical examination or laboratory tests during the screening period (ie, hemoglobin level <9.5 g/dL, white blood cells <2500 cells/mm3, aspartate aminotransferase and/or alanine aminotransferase ≥1.5 × the upper limit of normal [ULN], creatinine ≥1.25 × ULN, alkaline phosphatase ≥2 × ULN, and total bilirubin >ULN).