1. ADAPT Research Group. Naproxen and celecoxib do not prevent AD in early results from a randomized controlled trial. Neurology. 2007;68:1800–1808.
2. ADAPT Research Group. Cardiovascular and cerebrovascular results from the randomized, controlled Alzheimer’s Disease Anti-inflammatory Prevention Trial (ADAPT). PLoS Clin Trials. 2006; 1(7):e33.
3. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche PC, Lang T: The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Ann Intern Med. 2001; 134:663–694.
4. Amberson JB, Jr., McMahon BT, Pinner M. A clinical trial of sanocrysin in pulmonary tuberculosis. Am Rev Tuberc. 1931; 24:401–435.
5. American Bible Society. The Holy Bible: Old and New Testaments. King James Version (1611). New York: 1816.
6. Angell M. Industry-sponsored clinical research: A broken system. JAMA. 2008; 300:1069–1071.
7. Angell M. Investigators’ responsibility for human subjects in developing countries. N Engl J Med. 2000; 342:967–969.
(p.248) 8. Antithrombotic Trialists’ Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002; 324:71–86.
9. Antiplatelet Trialists’ Collaboration. Collaborative overview of randomized trials of antiplatelet therapy. I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. BMJ. 1994; 308:81–106.
10. Antman EM, Lau J, Kupeinick B, Mosteller F, Chalmers TC. A comparison of results of meta-analyses of randomized control trials and recommendations of clinical experts. JAMA. 1992; 268:240–248.
11. Bailey KR. Detecting fabrication of data in a multicenter collaborative animal study. Control Clin Trials. 1991; 12:741–752.
12. Baron J. The life of Edward Jenner: With illustrations of his doctrines and selections from his correspondence (book review). Br Foreign Med Rev. 1838; 6:477–497.
13. Bartolucci AA, Howard G. Meta-analysis of data from the six primary prevention trials of cardiovascular events using aspirin. Am J Cardiol. 2006; 98:746–750.
14. Beecher HK. Ethics and clinical research. N Engl J Med. 1966; 274:1354–1360.
15. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schultz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials: The CONSORT statement. JAMA. 1996; 276:637–639.
16. Berger JS, Roncaglioni MC, Avanzini F, Pangrazzi I, Tognoni G, Brown DL. Aspirin for the primary prevention of cardiovascular events in women and men: A sex-specific meta-analysis of randomized controlled trials. JAMA. 2006; 295:306–313.
17. Black’s Law Dictionary. St. Paul, MN: West Publishing Company, 1990.
18. Box JF. RA Fisher and the design of experiments, 1922–1926. Am Statistician. 1980; 34:1–7.
(p.249) 19. Broad WJ.: U.S. to penalize heart researchers on fraudulent project at Harvard. New York Times. 16 February 1983.
20. Brookmeyer R, Gray S, Kawas C. Projections of Alzheimer’s disease in the United States and the public health impact of delaying disease onset. Am J Pub Health. 1998; 88:1337–1342.
21. Canner PL. Aspirin in coronary heart disease: Comparison of six clinical trials. Isr J Med Sci. 1983; 19:413–423.
22. Childhood Asthma Management Program Research Group. The Childhood Asthma Management Program (CAMP): Design, rationale, and methods. Control Clin Trials. 1999; 20:91–120.
23. Collins JF, Garg R, Koon KT, Williford WO, Howell CL on behalf of DIG Investigators. The role of the data coordinating center in the IRB review and approval process: The DIG trial experience. Control Clin Trials. 2003; 24:306S–315S.
24. Colsky J. Clinical investigator: The clinical investigator and evaluation of new drugs. Am J Hosp Pharm. 1963; 20:517–519.
25. Connolly HM, Crary JL, McGoon MD, Hensrud DD, Edwards BS, Edwards WD, Schaff HV. Valvular heart disease associated with fenfluramine-phentermine. N Engl J Med. 1997; 337:581–588.
26. Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O’Sullivan MJ, VanDyke R, Bey M, Shearer W, Jacobson RL, Jimenez E, O’Neill E, Bazin B, Delfraissy J-F, Culnane M, Coombs R, Elkins M, Moye J, Stratton P, Balsley J., for the Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med. 1994; 331:1173–1180.
27. Cornfield J. Recent methodological contributions to clinical trials. Am J Epidemiol. 1976; 104:408–421.
28. Cornfield J. Design of clinical trials. In Goldstein M, ed., Research Status of Spinal Manipulative Therapy, pp. 303–306. Monograph no. 15. Bethesda, MD: National Institute of Neurological and Communicative Disorders and Stroke, 1975.
(p.250) 29. Coronary Drug Project Research Group. Clofibrate and niacin in coronary heart disease. JAMA. 1975; 231:360–381.
30. Coronary Drug Project Research Group. The Coronary Drug Project: Design, methods, and baseline results. Circulation. 1973; 47(Suppl I):I-1–I-50.
31. Couzin J. Drug testing: Massive trial of Celebrex seeks to settle safety concerns. Science. 2005; 310:1890–1891.
32. Creighton C. A history of epidemics in Britain: From the extinction of plague to the present time (vol. II). Cambridge: The University Press, 1894.
33. DeAngelis CD, Fontanarosa PB. Impugning the integrity of medical science: The adverse effects of industry influence. JAMA. 2008; 299:1833–1835.
34. DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJPM, Schroeder TV, Sox HC, Van Der Weyden MB: Clinical trial registration: A statement from the International Committee of Medical Journal Editors. JAMA. 2004; 292:1363–1364.
35. Department of Health and Human Services. Public Health Services policies on research misconduct; 42 CFR Parts 50 and 93. Federal Register. 2005; 70:28370–28400.
36. Dieckmann WJ, Davis ME, Rynkiewicz LM, Pottinger RE. Does the administration of diethylstilbestrol during pregnancy have therapeutic value?. Am J Obst Gynecol. 1953; 66:1062–1081.
37. Diehl HS, Baker AB, Cowan DW. Cold vaccines: An evaluation based on a controlled study JAMA. 1938; 111:1168–1173.
38. Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med. 1997; 336:525–533.
39. Drummond JC, Wilbraham A. The Englishman’s food: A history of five centuries of English diet. London: Jonathan Cape, 1940.
40. Fenner F, Henderson DA, Arita I, Landyi ID. Smallpox and its eradication. Geneva: World Health Organization, 1988.
(p.251) 41. Fergusson D, Glass KC, Hutton B, Shapiro S. Randomized controlled trials of aprotinin in cardiac surgery: Could clinical equipoise have stopped the bleeding? Clin Trials. 2005; 2:218–232.
42. Fisher B, Anderson S, Redmond CK, Wolmark N, Wickerham DL. Reanalysis and results after 12 years of follow-up in a randomized clinical trial comparing total mastectomy with lumpectomy with or without radiation in the treatment of breast cancer. N Engl J Med. 1995; 333:1456–1451.
43. Fisher B, Bauer M, Margolese R, Poisson R, Pilch Y, Redmond C, Fisher E, Wolmark N, Deutsch M, Montague E, et al: Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med. 1985; 312:665–73.
44. Fisher RA. Statistical methods and scientific inference (3rd edition). New York: Hafner Press, Macmillan Publishing Co., 1973.
45. Fisher RA. The arrangement of field experiments. J Ministry Agric Great Britain. 1926; 33:503–513.
46. Fisher RA, MacKenzie WA. Studies in crop variation: II. The manurial response of different potato varieties. J Agric Sci. 1923; 13:311–320.
47. Food and Drug Administration. Procedural and interpretative regulations: Investigational use. Federal Register. January 8, 1963; 28:179–182.
48. Fost N, Levine RJ. The dysregulation of human subjects research. JAMA. 2008; 298:2196–2198.
49. Francis T, Korns RF, Voigt RB, Boisen M, Hemphill FM, Napier JA, Tolchinsky E. An evaluation of the 1954 poliomyelitis vaccine trial: Summary report. Am J Public Health. 1955; 45(Part II, May Suppl):1–51.
50. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987; 317:141–145.
51. Freedman LS, Simon R, Foulkes MA, Friedman L, Geller NL, Gordon DJ, Mowery R. Inclusion of women and minorities in clinical trials and the NIH Revitalization Act of 1993—The perspective of NIH clinical trialists (with discussion and response). Control Clin Trials. 1995;16:277–312.
(p.252) 52. Freis ED. Historical development of antihypertensive treatment. In Laragh JH, Brenner BM, eds., Hypertension pathophysiology, diagnosis, and management, 2nd ed., Chapter 164, pp. 2741–2751. New York: Raven Press, 1995.
53. Glass GV. Primary, secondary and meta-analysis of research. Educational Researcher. 1976; 5:3–8.
54. Goodman SN. Toward evidence-based medical statistics. 1: The p value fallacy. Ann Intern Med. 1995; 130:995–1004.
55. Guay LA, Musoke P, Fleming T, Bagenda D, Allen M, Nakabito C, Sherman J, Bakaki P, Ducar C, Deseyve M, Emel L, Mirochnick M, Fowler MG, Mofenson L, Miotti P, Dransfield K, Bray D, Mmiro F, Jacksom JB: Intrapartum and neonatal single-dose nevirapine with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomized trial. Lancet 1999; 354:795–802.
56. Hayes SN, Redberg RF. Dispelling the myths: Calling for sex-specific reporting of trials results. Mayo Clin Proc. 2008; 83:523–525.
57. Haygarth J. Of the imagination, as a cause and as a cure of disorders of the body: Exemplified by fictitious tractors, and epidemical convulsions. Bath: R Cruttwell, 1800.
58. Herbst AL, Scully RE. Adenocarcinoma of the vagina in adolescence. A report of 7 cases including 6 clear-cell carcinomas (so-called mesonephromas). Cancer. 1970; 25:745–757.
59. Hill AB. Statistical methods in clinical and preventive medicine. New York: Oxford University Press, 1962.
60. Huff D. How to lie with statistics. Illustrated, I Geis. New York: Norton, 1954.
61. Hypertension Detection and Follow-Up Program Cooperative Group. Five-year findings of the Hypertension Detection and Follow-Up Program: I. Reduction in mortality of persons with high blood pressure, including mild hypertension. JAMA. 1979a; 242:2562–2571.
62. Hypertension Detection and Follow-up Program. Therapeutic control of blood pressure in the Hypertension Detection and Follow-up Program. Prev Med. 1979; 8:2–13.
(p.253) 63. Hypertension Prevention Trial Research Group, C Meinert, J Tonascia, S Tonasica, eds. The Hypertension Prevention Trial (HPT): Design, methods, and baseline results. Control Clin Trials. 1989; 10 (Suppl):1S–17S.
64. Ibarreta D, Swan SH: The DES story: Long-term consequences of prenatal exposure. In Harremoës P, Gee D, MacGarvin M, Stirling A, Keys J, Wynne B, Vaz SG, eds. Late lessons from early warnings: The precautionary principle 1896–2000. Chapter 8, pp. 84–91. Copenhagen: European Environment Agency, 2001.
65. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med. 1997; 336:309–315.
66. Jenner E. An inquiry into the causes and effects of the variolae vaccine. London: Sampson Low, 1798.
67. Johnson S. A dictionary of the English language. (2 vols.). Printed by W Strahan, for J and P Knapton; T and T Longman; C Hitch and L Hawes; A Millar; and R and J Dodsley, 1755.
68. Kassirer JP, Angell M. On authorship and acknowledgments. N Engl J Med. 1991; 325:1510–1512.
69. Kelsey FO. Government: The Kefauver-Harris Amendments and investigational drugs. Am J Hosp Pharm. 1963; 20:515–517.
70. Kluger J. Splendid solution: Jonas Salk and the conquest of polio. New York: Penguin Group (USA), 2005.
71. Last JM. A dictionary of epidemiology (4th edition). New York: Oxford University Press, 2001.
72. Levine RJ. Ethics and regulation of clinical research (2nd edition). New Haven: Yale University Press, 1988.
73. Lewis S, Clarke M.: Forest plots: Trying to see the wood and the trees. BMJ. 2001;322:1479–1480.
74. Lind J. A treatise of the scurvy (reprinted in Lind’s Treatise on scurvy, edited by CP Stewart, D Guthrie, Edinburgh University Press, Edinburgh, 1953). Edinburgh: Sands, Murray, Cochran, 1753.
(p.254) 75. MacLean C, Newberry S, Maglione M, McMahon M, Ranganath V, Suttorp M, et al. Systematic review: Comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med. 2008; 148:197–213.
76. Markel H. April 12, 1955 – Tommy Francis and the Salk Vaccine. N Engl J Med. 2005; 352:1408–1410.
77. Medical Research Council. Streptomycin treatment of pulmonary tuberculosis: A Medical Research Council investigation. Br Med J. 1948; 2:769–782.
78. Medical Research Council. Clinical trials of new remedies (annotations). Lancet. 1931; 2:304.
79. Meinert C, Gilpin AK, Ünalp A, Dawson C. Gender representation in trials. Control Clin Trials. 2000; 21:462–475.
80. Meinert CL. Controlled Clinical Trials (the journal). Encyclopedia of biostatistics, vol. 1, pp. 929–931. Chichester, UK: John Wiley & Sons,1998.
81. Meinert CL. Beyond CONSORT: Need for improved reporting standards for clinical trials. JAMA. 1998; 279:1487–1489.
82. Meinert CL. Masked monitoring in clinical trials—Blind stupidity?. N Engl J Med. 1998; 338:1381–1382.
83. Meinert CL. Clinical trials dictionary: Terminology and usage recommendations. Baltimore, MD: The Johns Hopkins Center for Clinical Trials, 1996.
84. Meinert CL, Tonascia S. Clinical trials:Design, conduct, and analysis. New York: Oxford University Press, 1986.
85. Miller PD, Epstein S, Sedarati F, Reginster JY. Once-monthly oral ibandronate compared with weekly oral alendronate in postmenopausal osteoporosis: Results from the head-to-head MOTION study. Curr Med Res Opin. 2008; 1:207–213.
86. Mills JL. Data torturing. N Engl J Med. 1993; 329:1196–1199.
87. Moher D. CONSORT: An evolving tool to help improve the quality of reports of randomized controlled trials. JAMA. 1998; 279:1489–1491.
(p.255) 88. Mount FW, Ferebee SH. Control study of comparative efficacy of isoniazid, streptomycin-isoniazid, and streptomycin-para-aminosalicylic acid in pulmonary tuberculosis therapy: II. Report on twenty-week observations on 390 patients with streptomycin-susceptible infections. Am Rev Tuberc. 1953a; 67:108–113.
89. Mount FW, Ferebee SH. Control study of comparative efficacy of isoniazid, streptomycin-isoniazid, and streptomycin-para-aminosalicylic acid in pulmonary tuberculosis therapy: III. Report on twenty-eight-week observations on 649 patients with streptomycin-susceptible infections. Am Rev Tuberc. 1953b; 67:539–543.
90. Mount FW, Ferebee SH. Control study of comparative efficacy of isoniazid, streptomycin-isoniazid, and streptomycin-para-aminosalicylic acid in pulmonary tuberculosis therapy: I. Report on twelve-week observations on 526 patients. Am Rev Tuberc. 1952; 66:632–635.
91. Multiple Risk Factor Intervention Trial Research Group. Statistical design considerations in the NHLI Multiple Risk Factor Intervention Trial (MRFIT). J Chronic Dis. 1977; 30:261–275.
92. Murray JAH, Bradley H, Craigie WA, Onion CT, eds. The Oxford English dictionary:A new English dictionary on historical principles (13 vols.). Oxford: Clarendon Press, 1970.
93. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. No. 1983–381–132:3205. Washington, DC: US Government Printing Office, 1979.
94. U.S. Congress. National Institutes of Health Revitalization Act of1993. §131, Pub L No 103–43, 107 Stat 133 (codified at 42 USC §289a-2).
95. National Institutes of Health Department of Health and Human Services: NIH Guidelines on the inclusion of women and minorities as subjects in clinical research. Federal Register. March 28 1994; 59:14508–14513.
96. National Institutes of Health. NIH Almanac. Publ. no. 81–5. Bethesda, MD: Division of Public Information, 1981b.
(p.256) 97. Neaton JD, Bartsch GE, Broste SK, Cohen JD, Simon NM, for the MRFIT Research Group. A case of data alteration in the Multiple Risk Factor Intervention Trials (MRFIT). Control Clin Trials. 1991; 12:731–740.
98. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infraction and death from cardiovascular causes. N Engl J Med. 2007; 356:2457–2471.
99. O’Brien PC. Data and safety monitoring. In Encyclopedia of biostatistics, vol. 2, pp. 1058–1066. Chichester: John Wiley & Sons, 1998.
100. Office for Protection from Research Risks. Code of Federal Regulations, Title 45: Public Welfare, Part 46: Protection of Human Subjects. Bethesda, MD: Department of Health and Human Services, National Institutes of Health, revised 18 June 1991.
101. Ogawa H, Nakayama M, Morimoto T, Uemura S, Kanauchi M, Doi N, Jinnouchi H, Sugiyama S, Saito Y, for the Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial Investigators. Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: A randomized controlled trial. JAMA. 2008; 300:2134–2141.
102. Packard FR. Life and times of Ambroise Paré, 1510–1590. New York: Paul B Hoeber, 1921.
103. Patulin Clinical Trials Committee (of the Medical Research Council). Clinical trial of Patulin in the common cold. Lancet. 1944; 2:373–375.
104. Peto R, Collins R, Sackett D, Darbyshire J, Babiker A, Buyse M, Stewart H, Baum M, Goldhirsh A, Bonadonna G, Valagussa P, Rutqvist L, Elbourne D, Davies C, Dalesio O, Parmar M, Hill C, Clarke M, Gray R, Doll R: The trials of Dr. Bernard Fisher: A European perspective on an American episode. Control Clin Trials. 1997; 18:1–13.
105. Physicians’ Health Study Research Group Steering Committee. Preliminary report: Findings from the aspirin component of the ongoing Physicians’ Health Study. N Engl J Med. 1988; 318:262–264.
106. Polman CH, O’Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips T, Lubin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW for the AFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006; 354:899–910.
107. Pruitt Jr. BA, Pruitt JH, Davis JH. Chapter 1, pp. 1–19. In Moore EE, Felficiano DV, Mattox KL, eds., Trauma (5th edition). New York: McGraw-Hill Professional, 2003.
108. Rennie D. Clinical trial misconduct. In Wiley encyclopedia of clinical trials. New York: John Wiley & Sons, 2007. Online at http://mrw.interscience.wiley.com/emrw/9780199742967/wect/article/eoct060/current/pdf
109. Rennie D. How to report randomized controlled trials: The CONSORT statement. JAMA. 1996; 276:649.
110. Ries LAG. Childhood cancer mortality. In Ries LAG, Smith MA, Gurney JG, Linet M, Tamra T, Young JL, Bunin GR, eds. Cancer incidence and survival among children and adolescents: United States SEER program: 1975–1995, pp. 165–170. SEER Monograph, Pub. No. 99–4649. Bethesda, MD: National Cancer Institute, 1999.
111. Rheumatic Fever Working Party of the Medical Research Council of Great Britain and the Subcommittee of Principal Investigators of the American Council of Rheumatic Fever and Congenital Heart Disease, American Heart Association. The evolution of rheumatic heart disease in children: Five year report of a cooperative clinical trial of ACTH, cortisone and aspirin. Circulation. 1960; 22:503–515.
112. Robinson D, Shettles L. The use of diethylstilbestrol in threatened abortion. Am J Obstet Gynecol. 1952; 63:1330–1333.
113. Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. Br Med J. 1996; 313:1390–1393.
114. Shuster E. Fifty years later: The significance of the Nüremberg Code. N Engl J Med. 1997; 337:1436–1440.
115. Stampfer MJ, Colditz GA. Estrogen replacement therapy and coronary heart disease: A quantitative assessment of the epidemiological data. Prev Med. 1991; 20:47–63.
(p.258) 116. Titus SL, Rhoades LJ. Repairing research integrity. Nature. 2008; 453:980–982.
117. Thomas KJ, MacPherson H, Trope L, Brazier J, Fitter M, Campbell MJ, Roman M, Walters SJ, Nicholl J: Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain. BMJ. 2006; 333:623.
118. Tucker WB. The evolution of the cooperative studies in the chemotherapy of tuberculosis of the Veterans Administration and Armed Forces of the USA: An account of the evolving education of the physician in clinical pharmacology. Adv Tuberc Res. 1960; 10:1–68.
119. United States Congress (103rd; 1st session). NIH Revitalization Act of 1993, 42 USC § 131 (1993); Clinical Research Equity Regarding Women and Minorities; Part I: Women and Minorities as Subjects in Clinical Research. 1993.
120. United States Congress (87th): Drug Amendments of 1962, Public Law 87–781, S 1522. Washington, DC, Oct 10, 1962.
121. United States Supreme Court. Forsham et al. versus Harris, Secretary of Health, Education and Welfare, et al. Certiorari to the United States Court of Appeals for the District of Columbia Circuit. No. 78–1118, argued Oct 31, 1979, decided March 3, 1980.
122. University Group Diabetes Program Research Group. Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes: VIII. Evaluation of insulin therapy: Final report. Diabetes. 1982; 31(Suppl 5):1–81.
123. University Group Diabetes Program Research Group. Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes: VII. Mortality and selected nonfatal events with insulin treatment. JAMA. 1978;240:37–42.
124. University Group Diabetes Program Research Group. A Study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes:V. Evaluation of Phenformin therapy. Diabetes. 1975; 24 (Suppl 1):65–184.
(p.259) 125. University Group Diabetes Program Research Group. A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes: I. Design, methods, and baseline characteristics. Diabetes. 1970; 19(Suppl 2):747–783.
126. University Group Diabetes Program Research Group. A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes: II. Mortality results. Diabetes 1970; 19(Suppl 2):785–830.
127. U.S. Preventive Services Task Force. Aspirin for the Primary Prevention of Cardiovascular Events: Recommendation and Rationale. Ann Inter Med. 2002; 136:157–160.
128. Vuthipongse P, Bhadrakom C, Chaisilwattana P, Roongpisuthipong A, Chalermchokcharoenkit A Chearskul S, Wanprapa N, Chokephaibulkit K, Tuchipda M, Wasi C, Chuachoowong R, Siriwasin W, Chinayon P, Asavapiriyanont S, Chotpitayasunondh T, Waranawat N, Sangtaweesin V, Horpaopan S, Queen Sirikit: Administration of zidovudine during late pregnancy and delivery to prevent perinatal HIV transmission – Thailand, 1996–1998. MMWR. 1998; 47:151–153.
129. Wells GA, Cranney A, Peterson J, Boucher M, Shea B, Robinson V, Coyle D, Tugwell P: Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev. 2008 Jan 23.
130. Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women’s Health Initiative Randomized Controlled Trial. JAMA. 2002; 288:321–333.
131. Yusuf S, Wittes J, Probstfield J, Tyroler HA. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA. 1991; 266:93–98.
132. Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DA. Issues in the registration of clinical trials. JAMA. 2007; 297:2112–2120.