Yes. At a minimum, proposed studies must include 3-point MACE (non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) as a primary outcome. Additional primary outcomes are permissible, including 4-point MACE (3-point MACE with revascularization or hospitalization for heart failure as additional endpoints). Other outcomes of interest include the individual components of MACE, all-cause mortality, glycemic control, renal function, medication side effects, weight gain or loss, and additional patient-centered outcomes (e.g., hypoglycemia). These outcomes may be included as primary or secondary endpoints, at the applicant’s discretion.
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