definiens: means the Phase 3 global clinical studiesfor the treatment of anemia in dialysis patients with chronic kidney disease, known informally asthe INNO2VATE studies, consisting of a conversion study and a correction study, and knownformally as the “ Phase 3, Randomized, Open - Label, Active - Controlled Study Evaluating theEfficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects withDialysis - Dependent Chronic Kidney Disease ( INNO2VATE – Conversion ) ” ( AKB-6548 - CI-0017)and the “ Phase 3, Randomized, Open - Label, Active - Controlled Study Evaluating the Efficacyand Safety of Oral Vadadustat for the Correction of Anemia in Subjects with Incident Dialysis - Dependent Chronic Kidney Disease ( INNO2VATE – Correction ) ” ( AKB-6548 - CI-0016 )