 - Abnormal Laboratory Findings: A clinically significant laboratory abnormality including Liver Function Tests at Visit 1 meeting the following criteria: Alanine aminotransferase ALT 2 x upper limit of normal ULN and bilirubin 1.5xULN isolated bilirubin 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin 35 percent . 