4. Laboratory parameters not within defined thresholds: white blood cells (WBC) < 4,000 cells/µL, hemoglobin (HgB) < 12 g/dL for females, < 13 g/dL for males, platelets < 150,000 per µL, albumin < 3.5 g/dL, international normalized ratio (INR) > 1.5, total bilirubin > 1.2 mg/dL, or alpha-fetoprotein (AFP) > 50 ng/mL. Subjects with an elevated indirect bilirubin and known Gilbert's disease can be included if direct bilirubin is within normal limits. Subjects with an AFP > 50 ng/mL but less than 500 ng/mL can be included if computed tomography (CT) scan or magnetic resonance imaging (MRI) performed within 3 months shows no evidence of hepatocellular carcinoma