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In patients with pulmonary arterial hypertension, the pulmonary vascular lumen is decreased as a result of vasoconstriction and vascular remodeling, resulting in increased pulmonary artery pressure and pulmonary vascular resistance.
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Local institutional review boards or independent ethics committees approved the protocol, and written informed consent and assent when appropriate was obtained from all patients.
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The comments from external review, which were kept anonymous, were provided to the Writing Group, which made revisions as they deemed appropriate.
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This study was a randomized double-blind placebo controlled clinical trial which has been approved by the ethical review board of Guilan Medical University.
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