- Participant met pre-specified criteria based on laboratory values at screening for the following: -- Alanine aminotransferase (ALT): ≤400 U/L -- Aspartate aminotransferase (AST): ≤400 U/L -- Total bilirubin: ≤2.4 mg/dL -- Direct bilirubin: ≤1.0 mg/dL -- Creatinine clearance (Clcr): ≥60 mL/min (by the Cockcroft-Gault equation*) -- Albumin: ≥3.3 g/dL -- Alkaline phosphatase: ≤260 U/L -- Hemoglobin: ≥13 g/dL (men), ≥12 g/dL (women) -- White blood cell count: 3.8 to 10.7 ×103/μL -- Absolute neutrophil count: ≥1.5 ×103/μL -- Platelet count: ≥120 ×103/μL -- International normalized ratio (INR): ≤1.2 -- Thyroid stimulating hormone (TSH): 0.34 to 5.60 μIU/mL -- Alpha fetoprotein (AFP): <100 ng/mL