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STRENGTH will examine whether Epanova 4 g daily reduces the rate of cardiovascular events in statin\u2010treated patients with hypertriglyceridemia and low levels of HDL\u2010C at high risk for developing cardiovascular events. STRENGTH is a randomized, double\u2010blind, placebo\u2010controlled trial. Patients had a triglyceride level\u2009\u2265\u2009180 to &lt;500\u2009mg\/dL and HDL\u2010C\u2009&lt;\u200942\u2009mg\/dL (men) or\u2009&lt;\u200947\u2009mg\/dL (women) in the presence of either (1) established atherosclerotic cardiovascular disease, (2) diabetes with one additional risk factor, or (3) were other high\u2010risk primary prevention patients, based on age and risk factor assessment. Patients should be treated with a statin, for &gt;4 weeks, and have LDL\u2010C\u2009&lt;\u2009100\u2009mg\/dL, but were also eligible if LDL\u2010C was \u2265100\u2009mg\/dL while on maximum tolerated statin therapy. The study will extend from October 30, 2014 to October 30, 2019. 13\u2009086 patients were randomized to Epanova 4 g or placebo daily in addition to standard medical therapy. The primary efficacy outcome is time to first event of cardiovascular death, myocardial infarction, stroke, coronary revascularization or hospitalization for unstable angina. The trial will continue until 1600 patients reach the primary endpoint, with a median duration of therapy of 3 years. STRENGTH will determine whether Epanova 4 g daily will reduce cardiovascular events in statin\u2010treated high\u2010risk patients with hypertriglyceridemia and low HDL\u2010C levels.<\/jats:p>","DOI":"10.1002\/clc.23055","type":"journal-article","created":{"date-parts":[[2018,8,20]],"date-time":"2018-08-20T00:10:47Z","timestamp":1534723847000},"page":"1281-1288","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":155,"title":["Assessment of omega\u20103 carboxylic acids in statin\u2010treated patients with high levels of triglycerides and low levels of high\u2010density lipoprotein cholesterol: Rationale and design of the STRENGTH trial"],"prefix":"10.1002","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9668-4368","authenticated-orcid":false,"given":"Stephen J.","family":"Nicholls","sequence":"first","affiliation":[{"name":"South Australian Health and Medical Research Institute, University of Adelaide  Adelaide Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. 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