Important outcomes Changing risk stratification, reclassification of CV risk Critical outcomes CV mortality Important outcomes Composite CV outcomes (as defined as the a priori outcome by individual studies) that could include any of the following: unstable angina, AMI, revascularization, stroke, CV mortality, all-cause mortality AMI fatal or non-fatal Stroke fatal or non-fatal All-cause mortality Key Question 7: Critical outcomes Adherence to lipid therapy medication >85% @ 1 year Important outcomes Changes in lipid levels (total-, LDL-, HDL-cholesterol, non-HDL cholesterol, TGs) Key Question 9: Critical outcomes Marginal cost-effectiveness Important outcomes Thresholds of cost-effectiveness for cost, effectiveness, utilities Sensitivity of cost-effectiveness to cost and effectiveness (ARR, RRR) e. Timing Key Question 1: 3 years follow-up No minimum follow-up Key Questions 4 6: 1 year follow-up Key Questions 8, 9: Lifetime horizon f. Settings Outpatient primary care (Key Question 2 also includes laboratory setting) B. Conducting the Systematic Evidence Review Based on the decisions made by the Champions and Work Group members regarding the scope, the KQs, and the PICOTS statements, the Lewin Team produced a systematic evidence review protocol prior to conducting the review. The protocol was reviewed and approved by the Champions and Work Group members. It described in detail the final set of KQs, the methodology to be used during the systematic evidence review process, and the inclusion/exclusion criteria to be applied to each potential study, including, but not limited to, study type, sample size, and PICOTS criteria. Extensive literature searches identified 16,836 citations potentially addressing the KQs of interest to this evidence review. Of those, 4,831 were excluded upon title review for clearly not meeting inclusion criteria (e.g., not pertinent to the topic, not published in English, published prior to study inclusion publication date, or not a full-length article). 