Complex/high risk arterial reconstruction at any time (graft vessel patency by Doppler ultrasound confirmed and documented).
10. Patients who are recipients of multiple solid organ transplants, (e.g.,
multivisceral or combined liver-kidney transplants), or have previously received an organ or tissue transplanted, or who received an ABO incompatible transplant.
11. Patients who have severe hypercholesterolemia (>215 mg/dL; >5.5 mmol/L) or
hypertriglyceridemia (>265 mg/dL; >3.0 mmol/L) at Baseline.
12. Patients who have severe thrombocytopenia or neutropenia (platelet count >20 and
MLCs>1000)
13. Patients who have any surgical or medical condition, which in the opinion of the
investigator, might significantly alter the absorption, distribution, metabolism and excretion of study drugs
14. Patients with a known hypersensitivity to the drugs used on study or their class,
or to any of the excipients.
15. Patients with clinically significant systemic infection 16. Pregnant or nursing (lactating) female patients, where pregnancy is defined as
the state of a female after conception and until the termination of gestation, confirmed by a positive βHCG laboratory test (>9 mIU/mL) at Baseline.