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

This study is an international, multicenter, randomized (2:1 active:placebo), double-blind,
placebo-controlled study in subjects with PAH who are NOT currently receiving approved
therapy for their PAH. Study visits will occur at 4 week intervals for 12 weeks (with an
additional visit at week 11) with the key measure of efficacy being the 6-minute walk test.
Study procedures include routine blood tests, medical history, physical exams, disease
evaluation, and exercise tests. Two optional substudies are also a part of FREEDOM-M at
select centers - a hemodynamic substudy with a right heart catheterization at Baseline and
Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and
Week 12.

Patients who complete all assessments for 12 weeks will also be eligible to enter a 36 month
open-label, extension phase study (FREEDOM - EXT).