2. The following screening laboratory parameters must be within the normal range: AST, ALT, alkaline phosphatase, hemoglobin, and serum creatinine. No repeat testing is allowed for these analytes. For any other clinical chemistry analyte or CBC (including differential and platelet count) parameter that is outside the normal range, the PI and the sponsor's medical monitor will confer and must agree in writing that the value has no clinical significance before the subject will be allowed to enter the study.