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2005P-0048
SUP 1
Volume 1

Cover Letter

Reference List

Reference 1 - American College of Gastroenterology. Letter to the FDA Docket 2005P-0048, May 4, 2005.

Reference 2 - American Diabetes Association. Aspirin therapy in diabetes. Diabetes Care. 2004; 27(1): S72-73. Published Material

Reference 3 - Antman EM, Anbe DT, Armstrong PW, et al. ACC/AHA Practice Guidelines. ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction). Developed in Collaboration With the Canadian Cardiovascular Society. ACC Foundation and the AHA, Inc. 2004; e1-e212. Published Material

Reference 4 - Berlin JA, Graham A, Colditz A. The role of meta-analysis in the regulatory process for foods, drugs and devices. JAMA. 1999; 281: 830-834. Published Material

Reference 5 - Berlin JA. The use of meta-analysis in pharmacoepidemiology. In: Strom BL, ed. Phamacoepidemiology. 3rd ed. West Sussex, England, UK: John Wiley & Sons, Ltd; 2000: 633-659. Published Material

Reference 6 - Cook DJ, Guyatt GH, Laupacis A, Sackett DL, Goldberg RJ. Clinical recommendations using levels of evidence for antithrombotic agents. Ched. 1995; 108: 227-230. Published Material

Reference 7 - Eikelboom JW, Hirsh J, Weitz JI, et al. Aspirin-resistant thromboxane biosynthesis and risk of myocardial infarction, stroke, or cardiovascular death in patients at high risk for cardiovascular events. Circulation. 2002; 105: 1650-1655. Published Material

Reference 8 - Guyatt GH. et al., Users’s guides to the medical literature - IX. A method for grading health care recommendations. JAMA. 1995; 274: 1800-1804. Published Material

Reference 9 - Michelson AD, Cattaneo M, Eikelboom JW, et al. Aspirin resistance: position paper of the working group on aspirin resistance, Platelet Physiology Subcommittee of the Scientific and Standardization Committee of the International Society of Thrombosis and Haemostasis. J Thrombosis & Haemostasis. 2005; 3: 1-3.

Reference 10 - National Stroke Association. Letter to FDA Docket 2005P-0048, May 23, 2005.

Reference 11 - PLAVIX (clopidogrel bisulfate) Prescribing Information, issued November 2004.

Reference 12 - Serebruany VL, Steinhubl SR, Berger PB, et al. The risk of bleeding after different doses of aspirin: A post-hoc analysis of 192,036 patients enrolled in 31 randomized controlled trials. Am J Card. 2005; 95: 1218-1222. Published Material

Reference 13 - Temple RJ. Meta-analysis and epidemiologic studies in drug development and postmarketing surveillance. JAMA. 1999;281(9):841-844. Published Material

Reference 14 - Temple RJ. The regulatory evolution of the integrated safety summary. Drug Information Journal. 1991; 25: 485-492. Published Material


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