5. Has abnormal Screening laboratory values that suggest a clinically significant underlying disease or participant has the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5×upper limit of normal (ULN); ALP >1.5×ULN in conjunction with elevated total bilirubin (TBILI), γ-glutamyl transferase (GGT), 5'-nucleotidase, AST, or ALT; alkaline phosphatase (ALP) >2×ULN persisting longer than 3 days; or ALP >3×ULN.