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Enrolled subjects received <jats:styled-content style=\"fixed-case\">PA<\/jats:styled-content>32540 once daily for up to 12\u00a0months and were assessed at baseline, month 1, month 6, and month 12.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The overall safety population consisted of 379 subjects, and 290 subjects (76%) were on <jats:styled-content style=\"fixed-case\">PA<\/jats:styled-content>32540 for \u2265348\u00a0days (12\u2010month completers). Adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s) caused study withdrawal in 13.5% of subjects, most commonly gastroesophageal reflux disease (1.1%). Treatment\u2010emergent <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s occurred in 76% of the safety population (11% treatment\u2010related) and 73% of 12\u2010month completers (8% treatment\u2010related). The most common treatment\u2010related <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content> was dyspepsia (2%). One subject had a gastric ulcer observed on for\u2010cause endoscopy. There were five cases of adjudicated nonfatal myocardial infarction, one nonfatal stroke, and one cardiovascular death, but none considered treatment\u2010related.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Long\u2010term treatment with <jats:styled-content style=\"fixed-case\">PA<\/jats:styled-content>32540 once daily for up to 12\u00a0months in subjects at risk for aspirin\u2010associated <jats:styled-content style=\"fixed-case\">UGI<\/jats:styled-content> events is not associated with any new or unexpected safety events.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1755-5922.12172","type":"journal-article","created":{"date-parts":[[2016,1,4]],"date-time":"2016-01-04T09:31:37Z","timestamp":1451899897000},"page":"59-66","source":"Crossref","is-referenced-by-count":10,"title":["Long\u2010Term Safety of a Coordinated Delivery Tablet of Enteric\u2010Coated Aspirin 325\u00a0mg and Immediate\u2010Release Omeprazole 40\u00a0mg for Secondary Cardiovascular Disease Prevention in Patients at <scp>GI<\/scp> Risk"],"prefix":"10.1111","volume":"34","author":[{"given":"Jay L.","family":"Goldstein","sequence":"first","affiliation":[{"name":"NorthShore University HealthSystem Evanston IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David J.","family":"Whellan","sequence":"additional","affiliation":[{"name":"Thomas Jefferson University Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James M.","family":"Scheiman","sequence":"additional","affiliation":[{"name":"University of Michigan Medical Center Ann Arbor MI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Byron L.","family":"Cryer","sequence":"additional","affiliation":[{"name":"University of Texas Southwestern Medical Center Dallas TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Glenn M.","family":"Eisen","sequence":"additional","affiliation":[{"name":"Oregon Health and Science University Portland OR USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angel","family":"Lanas","sequence":"additional","affiliation":[{"name":"University of Zaragoza Zaragoza Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John G.","family":"Fort","sequence":"additional","affiliation":[{"name":"POZEN Inc. 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