Table 2.

Primary and secondary study objectives and endpoints

Study objective	Corresponding endpoint
Primary objective
To determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the composite of CV death and HF events (hospitalization for HF or urgent HF visit) in patients with HF and preserved systolic function in (i) the full study population, and (ii) the sub‐population with LVEF <60%	Time to the first occurrencea of any of the components of this composite:1. CV death2. Hospitalization for HF3. Urgent HF visit (e.g. emergency department or outpatient visit)
Secondary objectives
To determine whether dapagliflozin is superior to placebo in reducing the total number of HF events (hospitalization for HF or urgent HF visit) and CV death in (i) the full study population, and (ii) the sub‐population with LVEF <60%	Total numberb of HF events (first and recurrent) and CV death
To determine whether dapagliflozin is superior to placebo in improving patient‐reported outcomes measured by KCCQ	Change from baseline in the total symptom score of the KCCQ at 8 months
To determine whether dapagliflozin is superior to placebo in reducing CV death	Time to the occurrence of CV death
To determine whether dapagliflozin is superior to placebo in reducing all‐cause mortality	Time to the occurrence of death from any cause
Safety objective
To evaluate the safety and tolerability of dapagliflozin compared to placebo in patients with HFpEF	Serious AEs, AEs leading to treatment discontinuation, amputations, AEs leading to amputation and potential risk factor for AEs leading to amputations affecting the lower limbs

AE, adverse event; CV, cardiovascular; HF, heart failure; HFpEF, heart failure with preserved ejection fraction; KCCQ, Kansas City Cardiomyopathy Questionnaire; LVEF, left ventricular ejection fraction.

^a Analysis using Cox regression stratified by type 2 diabetes at baseline.

^b Analysis performed using the semi‐parametric method of Lin, Wei, Yang and Ying (LWYY).