Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants

Inclusion criteria: * Written informed consent * Subject aged ≥18 years of a primary, orthotopic liver allograft, from a living donor * Subject negative for HIV Incusion criteria at Randomization: \- Subject was initated on tacrolimus-based immunosuppressive regimen with steroids and other immunosuppression Exclusion criteria: * Subjects transplanted for acute liver failure * HCV negativesubjects receiving a transplant from HCV positive donor * Subjects receiving multiple solid organ (including multiple liver lobes/segments) or islet cell tissue transplants, or have previously received an organ or tissue transplant. * Subjects receiving an ABO incompatible allograft. * MELD-score \> 35 within 1 month prior to transplantation. * Use of immunosuppressive or antibody induction agents not specified in the protocol. * History of malignancy of any organ system (except hepatocellular carcinoma or localized basal cell carcinoma of the skin) * Hepatocellular carcinoma with extrahepatic spread or macrovascular invasion * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 2 weeks after the last dose of study medication * History of hypersensitivity to any of the study drugs or to drugs with similar chemical class, or to any of the excipients Exclusion criteria at Randomization: * Any post-transplant history of thrombosis, occlusion or stent placement in any major hepatic arteries, hepatic veins, portal vein or inferior vena cava at any time during the run-in period prior to randomization. * Subjects with a confirmed spot urine protein/creatinine ratio that indicates ≥ 1.0 g/24 hrs of proteinuria * Subjects who have severe hypercholesterolemia (\>350 mg/dL; \>9.1 mmol/L) or hypertriglyceridemia (\>500 mg/dL; \>5.6 mmol/L) at randomization. * Subjects with platelet count \< 30,000/mm3. * Subjects with an absolute neutrophil count of \< 1,000/mm³ or white blood cell count of \< 2,000/mm³. * Subjects with systemic infection requiring active use of IV antibiotics. * Subjects requiring life support measures such as ventilation, dialysis, vasopressor agents. * Subjects who require renal replacement therapy within 7 days prior to randomization. * Subjects with detectable HBV DNA at time of randomization * Subjects meeting the following criteria for acute rejection during the run in period: * Any acute rejection in the week prior to randomization. * 2 treated acute rejections. * Any rejection requiring antibody treatment. * Any severe cellular (and/or any humoral) rejection. Long term extension for patients in Japan: Inclusion criteria * Written informed consent must be obtained before any extension specific assessment is performed. * Ability and willingness to adhere to study regimen. * Completed Month 24 visit of core study and continuously being treated with assigned regimen. Exclusion criteria: * Use of medication that is prohibited by the study protocol at Month 24. * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. * History of hypersensitivity to any of the study drugs or to drugs with similar chemical class, or to any of the excipients