The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).
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Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death
Timeframe: from months 24 to 36
Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death
Timeframe: from months 36 to 48
Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death
Timeframe: from months 24 to 36
Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death
Timeframe: from months 36 - 48
Change in Renal Function
Timeframe: from months 24 to 36