- Stable medical condition for three months prior to screening visit, with no clinically significant abnormalities of hepatic, renal, and hematologic function defined as follows: WBC within normal limits, platelets > 100,000, hemoglobin ≥11 mg/dL, srum creatinine ≤ 1.8 mg/dL, AST or ALT ≤ 1.5 ULN, no clinically significant abnormalities of other laboratory studies (CBC, chemistry panel, urinalysis).