A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients

Number of Patients With Treatment Failures

Incidence of treatment failures, assessed with composite criterion including treated biopsy proven acute rejection (tBPAR) with a rejection activity index (RAI) according to Banff classification \>3, graft loss or death at 6 months. Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted. The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft.

Time frame: At week 12 and week 24

Number of Patients With Treated or Not Treated Biopsy Proven Acute Rejection (BPAR)

Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy.

Time frame: at 12 week and 24 week

Number of Patients Reported With Different Categories of Severity of BPAR According to Banff Classification

Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy. The severity of BPAR was categorized as : Mild (Banff grade I, RAI = 4 and 5) Moderate (Banff grade II, RAI = 6 and 7) Severe (Banff grade III, RAI = 8 and 9) Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted.

Time frame: at 12 week and 24 week

Number of Patients With Treated or Untreated BPAR With RAI Score Greater Than 3

Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted. The patients with treated or untreated BPAR having RAI score \> 3 were reported in this end point.

Time frame: At 24 weeks

Number of Patients With Death or Graft Loss

The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft.

Time frame: at week 24

Change From Baseline (Randomization) in Serum Creatinine

Change in serum creatinine concentrations from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function. Baseline was Day 28 visit.

Time frame: Baseline, Week 24

Change From Baseline (Randomization) in Urine Protein/Creatinine Ratio

Change in urine protein/creatinine ratio from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function. Baseline was Day 28 visit.

Time frame: Baseline, week 24

Change From Baseline (Randomization) in Creatinine Clearance Estimated Using the Adjusted Cockcroft-Gault Formula

Creatinine clearance by the Cockcroft-Gault formula is computed in mL/min/1.73m\^2 from the creatinine clearance in mL/min by multiplying it by 1.73 and dividing it by the body surface area Baseline was Day 28 visit.

Time frame: Baseline, Week 24

Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by Abbreviated Modification of Diet in Renal Disease (MDRD) Formula

Change in glomerular filtration rate was calculated using the MDRD abbreviated formula. GFR in mL/min/1.73m\^2 for men of non-black ethnicity: 186 \* \[C/88\]\^-1.154 \* \[A\]\^-0.023\*G\*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit.

Time frame: Baseline, Week 24

Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by CKD-EPI Formula

GFR estimated by using the Chronic kidney disease- epidemiology (CKD-EPI) formula: eGFR (mL/min/1.73m\^2) = 141 \* min(C/K,1)\^ α \* max(C/K,1)\^-1.209 \* 0.993\^A \* 1.1018 (if male) \* 1.159 (if black) where C = serum creatinine (in mg/dL) ; A = Age (in years); K = 0.7 for women and 0.9 for men; α = -0.329 for women and -0.411 for men. Baseline was Day 28 visit.

Time frame: Baseline, Week 24

Number of Patients in Different Stages of Chronic Kidney Diseases According to the K/DOQI Classification System

Kidney disease outcomes quality initiative (K/DOQI) classification is based on glomerular filtration rate (GFR), abbreviated MDRD formula (mL/min/1.73m\^2) : Stage 1 : GFR \>= 90; Stage 2 = GFR was between 60-89; Stage 3 = GFR was between 30-59 ; Stage 4 = GFR was between 15-29; Stage 5 = GFR was \< 15 (or dialysis)

Time frame: At Week 24

Number of Patients With Any Adverse Events, Serious Adverse Events, Death and Premature Discontinuation

Baseline was Day 28 visit. This endpoint reports patients with total adverse events (any), serious adverse events, death and premature discontinuation.

Time frame: Baseline to 24 weeks