Termination criteria
1. Serum AST or ALT > 3 times ULN
2. Total serum bilirubin > 1.5 times ULN
- no study termination of a patient with documented Gilberts disease for an isolated bilirubin elevation unless it exceeds 2.5x the upper limit of normal.
3. Hematocrit > 55%
4. Subject experiences any