definiens: means the Phase 3 global clinicalstudies for the NDD - CKD Indication, known informally as the PRO2TECT study, consisting of aconversion study and a correction study, and known formally as the “ Phase 3, Randomized, Open - Label, Active - Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat forthe Maintenance Treatment of Anemia in Subjects with Non - Dialysis Dependent Chronic KidneyDisease ( PRO2TECT – Conversion ) ” and the “ Phase 3, Randomized, Open - Label, Active - Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction ofAnemia in Subjects with Non - Dialysis - Dependent Chronic Kidney Disease ( PRO2TECT – Correction ) ”