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Clinical trial protocols from the Phase 2 NEJM study used a gradual escalation approach, starting at low doses and increasing every four weeks

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Table 18: Treatment Effects for the Primary Endpoints* and their Components* in the DECLARE Trial Figure 4: Time to First Occurrence of Hospitalization for Heart Failure or CV Death in the DECLARE Trial Figure 5: Time to First Occurrence of Hospitalization for Heart Failure in the DECLARE Trial Chronic Kidney Disease The Trial to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with Chronic Kidney Disease (DAPA-CKD, NCT03036150) was an international, multicenter, randomized, double-blind, placebo-controlled trial in adult patients with chronic kidney disease (CKD) (eGFR between 25 and 75 mL/min/1.73 m) and albuminuria [urine albumin creatinine ratio (UACR) between 200 and 5000 mg/g] who were receiving standard of care background therapy, including a maximally tolerated, labeled daily dosage of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB)