Table 4.

Key Clinical Study Objectives and Estimands.

Question of Interest	Objective Description / Study Population	Endpoint	Intercurrent Events	Population Summary
Does chelation reduce ischemic events for patients with a history of MI and diabetes?	Primary Objective of the Study / All Randomized Participants	Time to randomization to death, stroke, MI, coronary revascularization, or hospitalization for unstable angina. All endpoint components except coronary revascularization are determined by the CEC.	All other intercurrent events will be ignored in these analyses. Supplemental analyses will censor deaths due to COVID-19 infection.	Hazard ratio estimate based on a Cox proportional hazards model. Values below 1.0 suggest benefit from chelation.
Does chelation reduce hard ischemic events for patients with a history of MI and diabetes?	Key Secondary Objective of the Study / All Randomized Participants	Time from randomization to death, stroke, or MI.	All other intercurrent events will be ignored in these analyses.	Hazard ratio estimate based on a Cox proportional hazards model. Values below 1.0 suggest benefit from chelation.
Does chelation reduce the death rate for patients with a history of MI and diabetes?	Key Secondary Objective of the Study / All Randomized Participants	Time from randomization to death.	All other intercurrent events will be ignored in these analyses.	Hazard ratio estimate based on a Cox proportional hazards model. Values below 1.0 suggest benefit from chelation.
Is chelation therapy safe to apply in a high-risk CAD population?	Key Secondary Objective of the Study / All Randomized Participants receiving at least one infusion of study drug	Total number of SAE and percentage of patients experiencing at least 1 SAE.	Some patients may decide to not take study drug after randomization and will be excluded from these analyses.