 - Laboratory examinations performed 7 days before enrollment with the following results: absolute neutrophil count of 1.5 × 109 L1, platelet count of 80 × 109L, total bilirubin level of 2 mgdL, AST and ALT levels of 2 times the upper limit of the reference range, and coagulation parameters 1.5 times the upper limit of the reference range 