- Having abnormal screening laboratory test values including bilirubin > 2.5 x ULN (upper limit of normal), AST/SGOT(aspartate aminotransferase/serum glutamin oxaloacetic transaminase) and ALT/SGPT (alanine aminotransferase/serum glutamic pyruvic transaminase) > 2.5 x ULN, serum creatinine > 1.5 mg/dL, blood glucose < 85 mg/dL or > 125 mg/dL, and TSH(thyroid stimulating hormone) > 4.12 µIU/mL, or other lab test result(s) that would preclude study participation in the judgement of the PI/Sub-I