 - Adequate baseline organ function defined as: Absolute neutrophils count1.5 x 109Liter L, hemoglobin9 grams gdL, Platelets75 x 109L, Prothrombin timeInternational normalized ratio1.3 x Upper limit of normal ULN, Partial thromboplastin time1.3 x ULN, Albumin2.5 gdL, Total bilirubin1.5 ULN, Aspartate aminotranseferase and Alanine aminotransferase 2.5 x ULN, Serum creatinineULN OR Estimated glomerular filtration rate30 millilite per Minute mLmin, Fasting Serum Glucose 126 mgdL, Hemoglobin A1C8. Note: Subjects with ALT or bilirubin values outside the ranges noted in the table above due to Gilberts syndrome or asymptomatic gallstones are not excluded. 