definiens: means the Phase 3 global clinical studies for theDD - CKD Indication, known informally as the INNO2VATE studies, 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 ofOral Vadadustat for the Maintenance Treatment of Anemia in Subjects with Dialysis - Dependent Chronic Kidney Disease ( INNO2VATE – Conversion ) ” ( AKB-6548 - CI-0017)and the “ Phase 3, Randomized, Open - Label, Active - Controlled Study Evaluating theEfficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects withIncident Dialysis - Dependent Chronic Kidney Disease ( INNO2VATE – Correction ) ” ( AKB-6548 - CI-0016).1.51