A 24 Month, Multicenter, Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

Inclusion Criteria:

- Ability and willingness to provide written informed consent and adhere to study
regimen.

- Recipients who are 18-70 years of age of a primary liver transplant from a deceased
donor.

- Recipients who have been initiated on an immunosuppressive regimen that contains
corticosteroids and tacrolimus, 3-7 days post-transplantation.

- Confirmed recipient HCV status at Screening (either by antibody or by PCR (Polymerase
Chain Reaction).

- Allograft is functioning at an acceptable level by the time of randomization as
defined by protocol specific laboratory values.

- Abbreviated MDRD eGFR ≥ 30 mL/min/1.73m2. Results obtained within 5 days prior to
randomization are acceptable, however no sooner than Day 25 post-transplantation.

- Verification of at least one tacrolimus trough level of ≥ 8 ng/mL in the week prior
to randomization. Investigators should make adjustments in tacrolimus dosing to
continue to target trough levels above 8 ng/mL prior to randomization.

Exclusion Criteria

- Patients who are recipients of multiple solid organ or islet cell tissue transplants,
or have previously received an organ or tissue transplant. Patients who have a
combined liver-kidney transplant.

- Recipients of a liver from a living donor, or of a split liver.

- History of malignancy of any organ system within the past 5 years whether or not
there is evidence of local recurrence or metastases, other than non-metastatic basal
or squamous cell carcinoma of the skin, or HCC (Hepatocellular Carcinoma) (see next
criteria).

- Hepatocellular carcinoma that does not fulfill Milan criteria (1 nodule ≤5 cm, 2-3
nodules all <3 cm) at the time of transplantation as per explant histology of the
recipient liver.

- Any use of antibody induction therapy.

- Patients with a known hypersensitivity to the drugs used on study or their class, or
to any of the excipients

- Patients who are recipients of ABO incompatible transplant grafts.

- Recipients of organs from donors who test positive for Hepatitis B surface antigen or
HIV are excluded.

- 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 drug.

- Women of child-bearing potential (WOCBP)

- Patients with any history of coagulopathy or medical condition requiring long-term
anticoagulation which would preclude liver biopsy after transplantation. (Low dose
aspirin treatment or interruption of chronic anticoagulant is allowed).

Other protocol-defined inclusion/exclusion criteria may apply.