 - Participants with normal major organ functions as defined by hemoglobin HgB 8.5 gramdecilitre dL, absolute neutrophil count ANC 1000microliter mcL, platelet 60,000micL, aspartate aminotransferasealanine transaminase ASTALT 3 x Upper Limit of Normal ULN, total Bilirubin 2 x ULN, creatinine 2 x ULN. 