definiens: means:(i)the phase 3, human clinical trial known as APD811 - 301, also referredto as the study, a study evaluating the efficacy and safety of ralinepag toimprove treatment outcomes in PAH ( the ) ; ( ii)the phase 3, human clinical trial known as APD811 - 303, also referredto as the study, an open label extension study to evaluate the-57- long - term safety and efficacy and safety of ralinepag in subjects with PAH ( the ) ; ( iii)the phase 2, human clinical trial known as APD811 - 007, an openlabel extension study in patients who completed study APD811 - 003;(iv)the phase 1, human clinical trial known as APD811 - 112, a phase 1,open label, single oral dose mass balance study to assess the mass balance and routes ofelimination of Ralinepag ; and(v)the phase 1, human clinical trial known as APD811 - 113, a phase 1single ascending dose escalation study to evaluate the pharmacokinetics, safety, and tolerabilityof a Ralinepag extended release tablet formulation in health Japanese and Caucasian malesubjects