Table 2.

Inclusion and exclusion criteria

Inclusion criteria

Male or female lung recipients 18–70 years of age undergoing primary double (including size reduction) lung transplantation

Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 36 months

Exclusion criteria

Recipients of multiorgan transplant, and/or previously transplanted with any organ, including previous lung transplantation

Patients with hypersensitivity to or other reasons to not be able to take the immunosuppressive drugs used in the study

Donor lung cold ischemic time > 12 h

Patients who previously have been treated with anti-thymocyte globulin preparations (e.g., ATG-Fresenius®, Thymoglobulin®)

Patients who are recipients of ABO-incompatible transplants

Patients with platelet count < 50,000/mm3 at the evaluation before transplantation

Patients who are unlikely to comply with the study requirements

Patients, and/or those receiving organs from donors, who are positive for HIV, hepatitis B surface antigen, or hepatitis C virus

Patients with donor older than 75 years

Patient who have received an unlicensed drug or therapy within 1 month prior to study entry or if such therapy is to be instituted post-transplantation

Patient unable to participate in the study for the full 36-month period

Patients with any past (within the past 3 years (low-risk malignancy) to 5 years (high-risk malignancy)) or present malignancy (other than excised basal cell carcinoma)

Women capable of becoming pregnant must have a negative pregnancy test prior to randomization