Table 1.

List of criteria for patient termination from the extension study.

  1. I. FDA approval of epoprostenol for use in patients with severe PAH/scleroderma spectrum of disease.

  2. II. Discontinuation of patient from the study due to one of the following reasons:

    1. Infusion was discontinued for more than 30 days

    2. Patient received a lung or heart-lung transplant

    3. Patient withdrew consent to participate in the study

    4. Patient received commercially available epoprostenol

    5. Patient was lost to followup

    6. The patient died