19. Has abnormal Screening or Day -1 laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 × the upper limits of normal. (ULN); alkaline phosphatase (ALP) >1.5 x ULN in conjunction with elevated total bilirubin, GGT, 5'-nucleotidase, AST, or ALT; ALP > 2 x ULN persisting longer than 3 days; ALP >3 x ULN, elevated sorbitol dehydrogenase, or abnormal urine osmolality