FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)

Inclusion Criteria:

• Between 12 and 75 years of age, inclusive.
• Body weight at least 40 kg with a Body Mass Index < 45
• PAH that is either idiopathic/heritable; associated with repaired congenitalsystemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vasculardisease; associated with HIV.
• Previous testing (e.g., right heart catheterization, echocardiography) consistent withthe diagnosis of PAH.
• Baseline 6-minute walk distance between 200 and 425 meters, inclusive.
• Reliable and cooperative with protocol requirements.

Exclusion Criteria:

• Nursing or pregnant.
• Currently receiving an endothelin receptor antagonist, a phosphodiesterase-5inhibitor, or prostacyclin within 30 days of Baseline.
• PAH due to conditions other than noted in the above inclusion criteria.
• History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heartdisease, uncontrolled systemic hypertension, or parenchymal lung disease.
• Use of an investigational drug within 30 days of Baseline.