Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a CNI-free Regimen With Enteric-Coated Mycophenolate Sodium (EC-MPS) and Everolimus in Comparison to Standard Therapy With Enteric-Coated Mycophenolate Sodium (EC-MPS) and Cyclosporine Microemulsion in de Novo Renal Transplant Patients
Brief Summary: The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion, but results in better renal function.


Options:
A: Inclusion Criteria:

* Male or female patients between 18 - 75 years
* Recipients of single-organ renal primary allograft or second renal transplants (provided that the previous graft was not lost from acute rejection within the first year) from living or cadaver donors
* Patients who provide written informed consent.

Exclusion Criteria:

* PRA \> 20% within 6 months prior to enrollment
* Cold ischemia time \> 30 hours
* Previous treatment with daclizumab
* History of malignancy (except localized skin cancer)
* Active peptic ulcer disease.
B: Inclusion Criteria :

The following inclusion criteria had to be present at BL 1 (Screening visit prior to transplantation):

1. Males or females, aged 18 - 65 years
2. Recipients of de novo cadaveric, living unrelated or living related kidney transplants
3. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at BL 1, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility
4. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained

   Of all patients included into the study at BL 1 (prior to transplantation), those who continued into the randomized study period had to meet the following condition at BL 2, prior to randomization:
5. Patients had to be on an immunosuppressive regimen with EC-MPS (target dose; 1440 mg/day, if tolerated; minimal dose: 720 mg/day), cyclosporine and corticosteroids
6. Patients with an actual serum creatinine =\< 3.0 mg/dl

Exclusion Criteria:

The following exclusion criteria must not be present at BL 1 (Screening visit prior to transplantation):

1. More than one previous renal transplantation
2. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
3. Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
4. Patients who are recipients of A-B-O incompatible transplants
5. Patients with a historical or current peak PRA of \> 25%
6. Patients with already existing antibodies against the HLA-type of the receiving transplant
7. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception

   Of all patients included into the study at BL 1 (prior to transplantation), those who met one or more of the following criteria at BL 2, prior to randomization, should not continue into the randomized study period:
8. Graft loss or death
9. Changes to the immunosuppressive regimen prior to randomization due to immunologic reasons
10. Patients who suffered from severe rejection (\>= BANFF II acute rejection), recurrent acute rejection, or steroid resistant acute rejection
11. Proteinuria \> 1g/day

Other protocol-defined exclusion criteria may apply.
C: Inclusion Criteria:

* End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor.
* Women who are of childbearing potential must have a negative pregnancy test before sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of sirolimus

Exclusion Criteria:

* Evidence of active systemic or localized major infection at the time of initial sirolimus administration
* Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
* Chronic antiarrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery
D: Inclusion Criteria:

* Primary or secondary kidney transplant
* Treatment with mycophenolic acid (MMF 1 g/d or EC-MPS 720 mg/d) and tacrolimus (trough concentration \[C0\] ≥ 5.5 ng/mL)
* Creatinine clearance ≥ 30 mL/min and \< 60 mL/min and stable renal function

Exclusion Criteria:

* Multi-organ recipients or previous transplant with any other organ different from kidney
* Biopsy proven acute rejection or treated acute rejection within the last 3 months.
* Prescription of mycophenolate mofetil 1 g/d or mycophenolate sodium 720 mg/d due to adverse event occurrence when higher doses were administered

Other protocol-defined inclusion/exclusion criteria may apply.

Answer: B