 - Subject has total aspartate aminotransferase AST or alanine aminotransferase ALT or alkaline phosphatase ALP greater than 2.5 times the ULN values at both Month 24 and at the previous visit i.e. Month 21 subjects with greater than 2.5 times ULN at Month 24 only are eligible for enrollment and should be managed as per label recommendations until normalization of the value 