Table 1. Composite Cardiovascular Score.

Status	Definition
Worsened	Any of the following conditions occur after randomization All cause death Occurrence of one or more of the following primary CV events: exacerbation of heart failure acute myocardial infarction atrial/ventricular arrhythmia unstable angina cardiac syncope transient ischemic attack stroke/cardiovascular accident complications of cardiac medications or cardiac procedures Permanent discontinuation of double-blind study drug due to CV reasons Permanent discontinuation of double-blind study drug because of refusal to participate, withdrawal of consent, or other administrative reasons AND at least one of the following occurred during the post-randomization period primary CV event on or prior to discontinuation of double-blind study drug increase of NYHA class on or prior to discontinuation of double-blind study drug death within 7 days following discontinuation of double-blind study drug
Improved	The criteria for “worsened” has not been previously met AND at least one of the following conditions occurred at the last assessment completed during the post-randomization period: Improvement in NYHA functional class Heart failure status (as determined by the clinician CGI-I score) is judged to be moderately-to-markedly improved
Unchanged	Participant is neither improved or worsened