<qa>  What is the upper limit of normal?12. Aspartate aminotransferase AST levels 3 X the upper limit of normal, alanine aminotransferase ALT levels 3 X the upper limit of normal, total bilirubin 1.5 X the upper limit of normal, or creatinine 1.5 X upper limit of normal on the Screening laboratory assessments, or other clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the subject from safely participating in trial. 