definiens: means the Phase 3 global clinicalstudies for the DD - CKD Indication, known informally as the INNO2VATE 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 VadadustatCompared to Epoetin Alfa in the Maintenance Treatment of Anemia of CKD in Subjects withDialysis - Dependent Chronic Kidney Disease ( INNO2VATE – Conversion ) ” and the “ Phase 3,Randomized, Open - Label, Active - Controlled Study Evaluating the Efficacy and Safety of OralVadadustat for the Correction of Anemia in Subjects with Incident Dialysis - Dependent ChronicKidney Disease ( INNO2VATE – Correction ) ”