Table 2.

Treatment-related AEs

TreatmentSubjectAE (grade)
Placebo1Elevated serum AST (I)
2Mildly elevated AST (I)
3Elevated serum ALT (I), elevated serum ALT (I), elevated serum amylase (II)
4Elevated serum AST (I)
Poly E 200 mg5Nausea (I), hypothyroidism (II)
6Belching (I)
7Belching (I)
Poly E 400 mg8Nausea (II), Vomiting (II)
9Elevated serum alkaline phosphatase (I)
10Elevated serum LDH (I), nausea (I)
Poly E 600 mg11Diarrhea (I), gas (I), nausea (I; 2 AEs), sour taste (I; 2 AEs), stomach discomfort (I), stomach pain (I), loss of energy (II)
12Elevated serum AST (I)
13Elevated serum LDH (I)