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Intervention details Outcome assessment Allocated: a 191, b 193 Completed: unclear Drop-out: unclear Assessed for GI symptoms: a 191, b 193 Outcomes reported: GI symptoms, endoscopic ulcers, GI drop-outs How were adverse events assessed: participants provided assessments of specific GI symptoms (abdominal pain, heartburn, nausea, vomiting, eructation, constipation, diarrhoea) How was compliance assessed: tablet count, less than 60% of the 2 tablet daily regimen were not evaluated Risk factors: history of gastric ulcers: a 82, b 84 history of duodenal ulcers: a 73, b 64 history of bleeds: a 18, b 25 FUNDING Funded by: GD Searle Affiliation of contact author: GD Searle Affiliation of statistician: unclear Affiliation of trial administrator: unclear No.
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Baseline GI status: no baseline endoscopy but excluded patients with definite peptic ulcer disease in the last 5 years Baseline NSAID status: excluded patients if never taken an NSAID Type and duration of arthritis (years): OA of the knee, no further details Age: a 59.
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