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Time to first occurrence of adjudication-confirmed narrowly defined MACE [ Time Frame: 120 weeks ]
Narrowly defined MACE(major adverse cardiac event) is defined as a single composite endpoint of CV death or non-fatal MI or stroke
Secondary Outcome Measures :
Time to first occurrence of adjudication-confirmed broadly defined MACE [ Time Frame: 120 weeks ]
Broadly defined MACE (major adverse cardiac event) is the occurrence of any of the following: CV death, non-fatal MI, hospitalization for CVD events, or stroke
Group difference in all-cause mortality [ Time Frame: 120 weeks ]
Percent change in apoA-I concentration over time within and between treatment groups [ Time Frame: 120 weeks ]
Percent change in apoB concentration over time within and between treatment groups [ Time Frame: 120 weeks ]
Percent change in LDL-C concentration over time within and between treatment groups [ Time Frame: 120 weeks ]
Percent change in HDL-C concentration over time within and between treatment groups [ Time Frame: 120 weeks ]
Percent change in TG concentration over time within and between treatment groups [ Time Frame: 120 weeks ]
Change in HbA1c over time within and between treatment groups [ Time Frame: 120 weeks ]
Change in fasting glucose over time within and between treatment groups [ Time Frame: 120 weeks ]
Change in fasting insulin over time within and between treatment groups [ Time Frame: 120 weeks ]
Change in alkaline phosphatase (ALP) over time within and between treatment groups [ Time Frame: 120 weeks ]
including isoforms for whole population and quartiles of ALP baseline concentration
Change in kidney function in population [ Time Frame: 120 weeks ]