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Intervention details Outcome assessment Allocated: a 58, b 53, c 60 Completed: a 46, b 25, c 45 Drop-out: a 12, b 28, c 15 Assessed for GI symptoms: a 58, b 53, c 60 Outcomes reported: GI symptoms, endoscopic ulcers, anaemia, GI drop-outs How were adverse events assessed: participants asked if there had been any problems since last visit How was compliance assessed: tablet count Risk factors: history of ulcers (1 year or more ago); a 10, b 14, c 14 all participants aged 60 years or more CVD: a 0, b 0 FUNDING Funded by: SmithKline Beecham Pharmaceuticals Affiliation of contact author: Arthritis Center, Phoenix, AZ, USA Affiliation of statistician: unclear Affiliation of trial administrator: unclear No.

Number and frequency of visits: 4 (0, 1, 3 and 6 weeks) Allocated: a 90, b 80 Completed: a 67, b 54 Drop-out: a 23, b 26 Assessed: a 90, b 80 Outcomes reported: mortality, serious GI complications, symptomatic ulcer, serious cardiac or renal illness, GI symptoms, anaemia, GI drop-outs How were adverse events assessed: not stated How was compliance assessed: capsule count, a 100% mean capsule intake; b 97.

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Aspirin allowed: not stated Analgesic allowed: not stated Participant education: not stated Washout: not stated Number and frequency of visits: 3 (0, 4 and 8 weeks) Allocated: a 269, b 269 Completed: a 219, b 206 Drop-out: a 50, b 63 Assessed: a 269, b 269 Outcomes reported: mortality, serious GI complications, serious cardiovascular or renal illness (extra data), GI symptoms, endoscopic ulcers, GI drop-outs, total drop-outs How were adverse events assessed: not stated How was compliance assessed: not stated Risk factors: history of ulcers: a 56, b 62 FUNDING Funded by: GD Searle Affiliation of contact author: university of Miami, USA Affiliation of statistician: unclear Affiliation of study administrator: unclear No.

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CONTROL Group B Total number analysed in this arm Death (all-cause, with reasons for death) Serious GI complications (pyloric obstruction, haemorrhage, haemorrhagic erosions, recurrent upper GI bleeds, perforation, inc death from any of these) Symptomatic ulcers (gastric, duodenal, oesophageal, inc bleeding ulcers) Serious cardiovascular or renal illness leading to contact with primary or secondary health care (inc.

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NSAIDs: open treatment with: indomethacin 100 mg daily: a 20, b 16 ketoprofen 150 mg daily: a 14, b 17 diclofenac 150 mg daily: a 19, b 17 Endoscopy: 3 weeks Other medication: none were receiving antisecretory drugs or any mucosal protective drug at time of study Aspirin allowed: not stated Analgesic allowed: not stated Participant education: not stated Washout: at least 7 days for previous NSAIDs Number and frequency of visits: 2 (0 and 3 weeks) Allocated: a 57, b 57 Completed: a 53, b 50 Drop-out: a 4, b 7 Assessed: a 53, b 50 Outcomes reported: serious GI complications, GI symptoms, endoscopic ulcers, total drop-out How were adverse events assessed: not stated How was compliance assessed: not stated Risk factors: CVD: a 0, b 0 FUNDING Funded by: not stated Affiliation of contact author: Sacco University Hospital, Italy Affiliation of statistician: unclear Affiliation of trial administrator: unclear No.

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