15. Patients with clinically significant abnormal laboratory results in clinical chemistry, hematology or urinalysis as defined by Appendix 9, including serum glutamic-oxaloacetic transaminase/aspartate aminotransferase (AST) or serum glutamic-pyruvic transaminase/alanine aminotransferase (ALT) ≥ 3.0 times the upper limit of the reference range or a serum creatinine ≥ 2.0 mg/dL at screening.