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The pre-specified secondary outcomes were (1) all cause-mortality and (2) incidence of a cardiovascular composite event outcome that included: first occurrence of acute myocardial infarction, cardiac arrest or ventricular fibrillation, acute stroke, or coronary revascularization, as previously described and validated using validated International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) and 10th Revision, Clinical Modification (ICD-10-CM) and procedure codes 52,53,54