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Potential weaknesses of the LEADER model include that all patients were of high or higher CV risk than those in the SUSTAIN and PIONEER efficacy trials, which may have affected the analysis at the lower end of the continuum of risk
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AdamsJBAudhyaTMcDonough-MeansSRubinRAQuigDGeisEet al
Due to the exploratory nature of this study, a formal sample size calculation was not performed, and the sample size was chosen based on feasibility and prior studies [4]
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