Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant

The objective of this study was to asses the safety and efficacy of FK506E (MR4) as a
long-term treatment in transplant recipients. Only patients who had participated in one of
the phase II PK or phase III studies on FK506E (MR4) and had received at least one dose of
study medication were enrolled.

Inclusion Criteria:

- Patients who had already participated in the previous phase II pharmacokinetic or
phase III studies with FK506E (MR4).

- Patients capable of understanding the purpose and risks of the study, who had been
fully informed and given written informed consent to participate in the study.

Exclusion Criteria:

- Pregnant women or nursing mothers.

- Women unwilling or unable to use adequate contraception during the study.