• Subject must meet the following criteria as indicated on the
clinical laboratory tests: • Serum aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN) • Serum
total bilirubin ≤ 1.5 x ULN • Serum creatinine ≤ 1.5 x ULN or an
estimated glomerular filtration rate of > 50 mL / min as calculated by the Modification of Diet in Renal Disease equation.