Crossref journal-article
Elsevier BV
Controlled Clinical Trials (78)
Bibliography

Design of the Women’s Health Initiative Clinical Trial and Observational Study. (1998). Controlled Clinical Trials, 19(1), 61–109.

Authors 0

None

References 117 Referenced 2,180
  1. {'key': '10.1016/S0197-2456(97)00078-0_BIB1', 'first-page': '50', 'article-title': 'The evolution of the Women’s Health Initiative', 'volume': '50', 'author': 'Rossouw', 'year': '1995', 'journal-title': 'J Am Med Women’s Assoc'} / J Am Med Women’s Assoc / The evolution of the Women’s Health Initiative by Rossouw (1995)
  2. 10.1001/archinte.1990.00390140121026 / Arch Intern Med / Results of a randomized feasibility study of a low-fat diet by Insull (1990)
  3. 10.1016/0091-7435(90)90014-B / Prevent Med / Feasibility of a randomized trial of a low-fat diet for the prevention of breast cancer by Henderson (1990)
  4. {'key': '10.1016/S0197-2456(97)00078-0_BIB4', 'first-page': '507', 'article-title': 'The Women’s Health Trial', 'volume': '6', 'author': 'WHT:FSMP Investigator’s Group', 'year': '1996', 'journal-title': 'Ann Epidemiol'} / Ann Epidemiol / The Women’s Health Trial by WHT:FSMP Investigator’s Group (1996)
  5. 10.1001/jama.1995.03520270033028 / JAMA / Effects of estrogen or estrogen/progestin regimes on heart disease risk factors in postmenopausal women by PEPI Trial Writing Group (1995)
  6. 10.1001/jama.1996.03530290040035 / JAMA / Effects of hormone replacement therapy on endometrial histology in postmenopausal women by PEPI Trial Writing Group (1996)
  7. 10.1001/jama.1996.03540170033029 / JAMA / Effects of hormone therapy on bone mineral density by PEPI Trial Writing Group (1996)
  8. {'issue': 'suppl', 'key': '10.1016/S0197-2456(97)00078-0_BIB8', 'first-page': '2024S', 'article-title': 'The lessons of life', 'volume': '52', 'author': 'Doll', 'year': '1992', 'journal-title': 'Cancer Res'} / Cancer Res / The lessons of life by Doll (1992)
  9. 10.1093/jnci/80.11.802 / J Natl Cancer Inst / Aspects of the rationale for the Women’s Health Trial by Prentice (1988)
  10. {'key': '10.1016/S0197-2456(97)00078-0_BIB10', 'first-page': '468', 'article-title': 'Genesis and growth of tumors III. Effects of a high-fat diet', 'volume': '2', 'author': 'Tannenbaum', 'year': '1942', 'journal-title': 'Cancer Res'} / Cancer Res / Genesis and growth of tumors III. Effects of a high-fat diet by Tannenbaum (1942)
  11. {'key': '10.1016/S0197-2456(97)00078-0_BIB11', 'first-page': '3374', 'article-title': 'Experimental evidence of dietary factors and hormone-dependent cancers', 'volume': '35', 'author': 'Carroll', 'year': '1975', 'journal-title': 'Cancer Res'} / Cancer Res / Experimental evidence of dietary factors and hormone-dependent cancers by Carroll (1975)
  12. {'key': '10.1016/S0197-2456(97)00078-0_BIB12', 'first-page': '1997', 'article-title': 'Requirement of essential fatty acid for mammary tumorigenesis in the rat', 'volume': '451', 'author': 'Ip', 'year': '1985', 'journal-title': 'Cancer Res'} / Cancer Res / Requirement of essential fatty acid for mammary tumorigenesis in the rat by Ip (1985)
  13. {'key': '10.1016/S0197-2456(97)00078-0_BIB13', 'first-page': '5710', 'article-title': 'Analysis of dietary fat, calories, body weight, and the development of mammary tumors in rats and mice', 'volume': '40', 'author': 'Freedman', 'year': '1990', 'journal-title': 'Cancer Res'} / Cancer Res / Analysis of dietary fat, calories, body weight, and the development of mammary tumors in rats and mice by Freedman (1990)
  14. 10.1080/01635588509513831 / Nutr Cancer / Dietary fat and mammary carcinogenesis by Carroll (1985)
  15. Newberne PM, Schrager TE, Conner MW. Experimental evidence on the nutritional prevention of cancer. In: Moon TE, Micozzi MS, eds. Nutrition and Cancer Prevention: Investigating the Role of Micronutrients. New York: Marcel Dekker Inc, 1989, pp. 33–84.
  16. 10.1007/978-1-4615-2510-3_9 / Advances in Experimental Medicine and Biology / Meta-analysis of animal experiments by Freedman (1994)
  17. Henderson M. Correlations between fatty acid intake and cancer incidence. In: Nelson GH, ed. Health Effects of Dietary Fatty Acids. Champaign IL: American Oil Chemist’s Society, 1991, pp. 136–149.
  18. 10.1080/01635589109514124 / Nutr Cancer / Quantitative review of studies of dietary fat and rat colon carcinoma by Zhao (1991)
  19. {'key': '10.1016/S0197-2456(97)00078-0_BIB19', 'first-page': '473', 'article-title': 'Critical appraisal of the evidence that dietary fat is related to breast cancer risk in humans', 'volume': '79', 'author': 'Goodwin', 'year': '1987', 'journal-title': 'J Natl Cancer Inst'} / J Natl Cancer Inst / Critical appraisal of the evidence that dietary fat is related to breast cancer risk in humans by Goodwin (1987)
  20. 10.1002/1097-0142(19861201)58:11<2363::AID-CNCR2820581102>3.0.CO;2-# / Cancer / International comparison of mortality rates of cancer of the breast, ovary, prostate and colon and per capita food consumption by Rose (1988)
  21. 10.1016/0091-7435(90)90025-F / Prev Med / Types of dietary fat and the incidence of breast cancer at five sites by Hursting (1990)
  22. 10.1007/BF00053187 / Cancer Causes Contr / Dietary fat and cancer by Prentice (1990)
  23. 10.1093/jnci/82.7.561 / J Natl Cancer Inst / Dietary factors and risk of breast cancer by Howe (1990)
  24. 10.1056/NEJM199602083340603 / N Engl J Med / Cohort studies of fat intake and the risk of breast cancer by Hunter (1996)
  25. 10.1023/A:1018476414781 / Cancer Causes Contr / The relationship between dietary fat intake and risk of colorectal cancer by Howe (1997)
  26. {'key': '10.1016/S0197-2456(97)00078-0_BIB26', 'first-page': '4633', 'article-title': 'Dietary fat and the risk of colorectal cancer', 'volume': '44', 'author': 'Stemmerman', 'year': '1984', 'journal-title': 'Cancer Res'} / Cancer Res / Dietary fat and the risk of colorectal cancer by Stemmerman (1984)
  27. 10.1056/NEJM199012133232404 / N Engl J Med / Relation of meat, fat and fiber intake to the risk of colon cancer in a prospective study among women by Willett (1990)
  28. {'key': '10.1016/S0197-2456(97)00078-0_BIB28', 'first-page': '3727', 'article-title': 'Dietary fat intake and cancer incidence among five ethnic groups in Hawaii', 'volume': '41', 'author': 'Kolonel', 'year': '1981', 'journal-title': 'Cancer Res'} / Cancer Res / Dietary fat intake and cancer incidence among five ethnic groups in Hawaii by Kolonel (1981)
  29. {'key': '10.1016/S0197-2456(97)00078-0_BIB29', 'first-page': '751', 'article-title': 'Cancer in migrants to Australia', 'volume': '48', 'author': 'McMichael', 'year': '1988', 'journal-title': 'Cancer Res'} / Cancer Res / Cancer in migrants to Australia by McMichael (1988)
  30. 10.1093/jnci/85.22.1819 / J Natl Cancer Inst / Migrant patterns and breast cancer risk in Asian-American women by Ziegler (1993)
  31. 10.1093/jnci/87.15.1154 / J Natl Cancer Inst / Breast cancer mortality among immigrants in Australia and Canada by Kliewer (1995)
  32. 10.1093/oxfordjournals.aje.a114086 / Am J Epidemiol / Reproducibility and validity of a semiquantitative food frequency questionnaire by Willett (1985)
  33. 10.1056/NEJM199212313272701 / N Engl J Med / Discrepancy between self-reported and actual calorie intake and exercise in obese subjects by Lichtman (1992)
  34. 10.1136/bmj.311.7011.986 / Br Med J / Dietary underreporting by obese individuals by Heitmann (1995)
  35. 10.1093/jnci/88.23.1738 / J Natl Cancer Inst / Measurement error and results from analytic epidemiology by Prentice (1996)
  36. {'key': '10.1016/S0197-2456(97)00078-0_BIB36', 'first-page': '315', 'article-title': 'Maintenance of a low-fat diet', 'volume': '1', 'author': 'White', 'year': '1992', 'journal-title': 'Cancer Epidemiol Biomark Prev'} / Cancer Epidemiol Biomark Prev / Maintenance of a low-fat diet by White (1992)
  37. {'key': '10.1016/S0197-2456(97)00078-0_BIB37', 'first-page': '217', 'article-title': 'Long-term effects of participation in a randomized trial of a low-fat, high-carbohydrate diet', 'volume': '5', 'author': 'Boyd', 'year': '1996', 'journal-title': 'Cancer Epidemiol Biomark Prev'} / Cancer Epidemiol Biomark Prev / Long-term effects of participation in a randomized trial of a low-fat, high-carbohydrate diet by Boyd (1996)
  38. 10.1016/S0002-8223(21)03296-X / J Am Diet Assoc / Dietary fiber in the reduction of colon cancer risk by Greenwald (1987)
  39. Trock BJ, Lanza E, Greenwald P. High-fiber diet and colon cancer: a critical review. In: Mettlin CJ, Aoki K, eds. Recent Progress in Research on Nutrition and Cancer. Progress in Clinical and Biological Research, 1990;346:145–158.
  40. 10.1093/jnci/84.24.1887 / J Natl Cancer Inst / Dietary intake of fiber and decreased risk of cancer of the colon and rectum by Howe (1992)
  41. Keys A. Seven Countries: A multivariate analysis of death and coronary heart disease. Cambridge, MA: Harvard University Press, 1980. (10.4159/harvard.9780674497887)
  42. 10.1016/S0002-9149(77)80198-7 / Am J Cardiol / Epidemiologic studies in coronary heart disease and stroke in Japanese men living in Japan, Hawaii, and California by Robertson (1977)
  43. 10.1016/S0140-6736(80)90003-3 / Lancet / Changes in plasma lipids and lipoproteins after a modified fat diet by Ernst (1980)
  44. 10.1016/S0002-8223(21)08023-8 / J Am Diet Assoc / The effect of diet on plasma lipids, lipoproteins, and coronary heart disease by Kris-Etherton (1988)
  45. The Lipid Research Clinics Coronary Primary Prevention Trial results: I. Reduction in incidence of coronary heart disease. JAMA 1984;251:351–364. (10.1001/jama.1984.03340270029025)
  46. 10.1056/NEJM198711123172001 / N Engl J Med / Helsinki Heart Study by Frick (1987)
  47. {'key': '10.1016/S0197-2456(97)00078-0_BIB47', 'first-page': '1383', 'article-title': 'Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease', 'volume': '344', 'author': 'Scandinavian Simvastatin Study Group', 'year': '1994', 'journal-title': 'Lancet'} / Lancet / Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease by Scandinavian Simvastatin Study Group (1994)
  48. Tinker LF, Burrows ER, Henry H, et al. The Women’s Health Initiative: overview of the nutrition components. In: Krummel DA, Kris-Etherton PM, eds. Nutrition in Women’s Health. Gaithersburg, MD: Aspen Publishers, 1996, pp. 510–542.
  49. 10.1016/S0735-1097(86)80293-5 / J Am Coll Cardio / Fifteen-year mortality in Coronary Drug Project patients by Canner (1986)
  50. 10.3109/00365597509180912 / Scand J Urol Nephrol / Serum lipid levels and thromboembolic complications during estrogen therapy of prostatic cancer by Sotaniemi (1975)
  51. 10.1001/jama.242.11.1150 / JAMA / Risk of vascular disease in women by Petitti (1979)
  52. 10.1001/jama.1991.03460140089033 / JAMA / Estrogen and coronary heart disease in women by Barrett-Connor (1991)
  53. Korneman GS, ed. The Menopause: Biological and Clinical Consequences of Ovarian Failure: Evolution and Management. Norwell, MA: Serono Symposia, 1990, pp. 211–224.
  54. 10.1016/0002-8703(87)90552-7 / Am Heart J / Sex, plasma lipoproteins, and atherosclerosis by Godsland (1987)
  55. 10.1056/NEJM198909073211004 / N Engl J Med / Menopause and risk factors for coronary heart disease by Matthews (1989)
  56. 10.1016/0091-7435(91)90006-P / Prev Med / Estrogen replacement therapy and coronary heart disease by Stampfer (1991)
  57. 10.7326/0003-4819-117-12-1016 / Ann Intern Med / Hormone therapy to prevent disease and prolong life in postmenopausal women by Grady (1992)
  58. 10.1001/archinte.1991.00400010095012 / Arch Intern Med / Decreased mortality in users of estrogen replacement therapy by Henderson (1991)
  59. 10.1161/01.CIR.75.6.1102 / Circulation / Cardiovascular mortality and noncontraceptive use of estrogen in women by Bush (1987)
  60. 10.1097/00006250-197907000-00017 / Obstet Gynecol / Estrogen replacement therapy II by Nachtigall (1979)
  61. 10.1016/0378-5122(90)90007-S / Maturitas / Effects of post-menopausal oestrogen-progestogen replacement therapy on serum lipids and lipoproteins by Rijpkema (1990)
  62. 10.1056/NEJM199110243251702 / N Engl J Med / Effects of postmenopausal estrogen replacement on the concentration and metabolism of plasma lipoproteins by Walsh (1991)
  63. 10.7326/0003-4819-121-12-199412150-00005 / Ann Intern Med / Estrogen improves endothelium-dependent, flow-mediated vasodilation in postmenopausal women by Lieberman (1994)
  64. {'key': '10.1016/S0197-2456(97)00078-0_BIB64', 'first-page': '1021', 'article-title': 'A review of postmenopausal hormone therapy recommendations', 'volume': '82', 'author': 'Hemminki', 'year': '1993', 'journal-title': 'Obstet Gynecol'} / Obstet Gynecol / A review of postmenopausal hormone therapy recommendations by Hemminki (1993)
  65. 10.1016/0002-9378(90)90602-4 / Am J Obstet Gynecol / Prevalence and determinants of estrogen replacement therapy in elderly women by Cauley (1990)
  66. 10.1093/oxfordjournals.aje.a117553 / Amer J Epid / for the ACAPS Investigators. Estrogen replacement therapy and progression of intimal-medial thickness in the carotid arteries of postmenopausal women by Espeland (1995)
  67. 10.1056/NEJM199109123251102 / N Engl J Med / Postmenopausal estrogen therapy and cardiovascular disease by Stampfer (1991)
  68. 10.1136/bmj.298.6667.147 / Br Med J / Risk of endometrial cancer after treatment with oestrogens alone or in conjunction with progestogens by Persson (1989)
  69. 10.1056/NEJM199109123251108 / N Engl J Med / Uncertainty about postmenopausal estrogen by Goldman (1991)
  70. 10.1001/archinte.1993.00410120009002 / Arch Intern Med / A review of the association of estrogens and progestins with cardiovascular disease in postmenopausal women by Psaty (1993)
  71. 10.1056/NEJM199310143291601 / N Engl J Med / The effect of postmenopausal estrogen therapy on bone density in elderly women by Felson (1993)
  72. 10.7326/0003-4819-122-1-199501010-00002 / Ann Intern Med / for the study of Osteoporotic Fractures Research Group. Estrogen replacement therapy and fractures in older women by Cauley (1995)
  73. 10.1007/BF01623222 / Osteoporosis Inc. / New bisphosphonates in osteoporosis by Fleisch (1993)
  74. 10.1001/jama.1991.03460150089030 / JAMA / A meta-analysis of the effect of estrogen replacement therapy on the risk of breast cancer by Steinberg (1991)
  75. 10.1001/archinte.1991.00400010089011 / Arch Intern Med / Menopausal estrogen replacement therapy and breast cancer by Dupont (1991)
  76. 10.1056/NEJM198908033210505 / N Engl J Med / The risk of breast cancer after estrogen and estrogen-progestin replacement by Bergkvist (1989)
  77. 10.1056/NEJM199506153322401 / N Engl J Med / The use of estrogens and progestins and the risk of breast cancer in postmenopausal women by Colditz (1995)
  78. 10.1001/jama.1995.03530020055032 / JAMA / Combined estrogen and progestin hormone replacement therapy in relation to risk of breast cancer in middle-aged women by Stanford (1995)
  79. {'key': '10.1016/S0197-2456(97)00078-0_BIB79', 'first-page': '987', 'article-title': 'Metabolic impact of adding medroxyprogesterone acetate to conjugated estrogen therapy in postmenopausal women', 'volume': '84', 'author': 'Lobo', 'year': '1994', 'journal-title': 'Obstet Gynecol'} / Obstet Gynecol / Metabolic impact of adding medroxyprogesterone acetate to conjugated estrogen therapy in postmenopausal women by Lobo (1994)
  80. 10.1016/0029-7844(94)00339-F / Obstet Gynecol / Use of menopausal estrogens and medroxyprogesterone in the United States, 1982–92 by Wysowski (1995)
  81. {'key': '10.1016/S0197-2456(97)00078-0_BIB81', 'first-page': '759', 'article-title': 'The minimum effective dose of estrogen for preventing postmenopausal bone loss', 'volume': '63', 'author': 'Lindsay', 'year': '1984', 'journal-title': 'Obstet Gynecol'} / Obstet Gynecol / The minimum effective dose of estrogen for preventing postmenopausal bone loss by Lindsay (1984)
  82. 10.1097/00006250-199004001-00013 / Obstet Gynecol / The role and use of progestogens by Whitehead (1990)
  83. 10.1001/archinte.149.1.133 / Arch Int Med / Estrogen replacement therapy by Ferguson (1989)
  84. 10.1001/archinte.1989.00390110045010 / Arch Intern Med / Lifetime risks of hip, Colles’ or vertebral fracture and coronary heart disease among white postmenopausal women by Cummings (1989)
  85. 10.1016/0140-6736(93)92555-8 / Lancet / Bone density at various sites for prediction of hip fractures by Cummings (1993)
  86. 10.1093/ajcn/43.2.299 / Am J Clin Nutr / Distribution of calcium absorption in middle-aged women by Heaney (1986)
  87. 10.1002/jbmr.5650040404 / J Bone Miner Res / Calcium absorption in women by Heaney (1989)
  88. Peck WA, Burckhardt P, Christiansen C, et al. Consensus Development Conference: Diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med 1993;94:646–650. (10.1016/0002-9343(93)90218-E)
  89. {'key': '10.1016/S0197-2456(97)00078-0_BIB89', 'first-page': '1', 'article-title': 'Dietary intake of vitamins, minerals, and fiber of persons ages 2 months and over in the United States', 'volume': '14', 'author': 'Alaimo', 'year': '1994', 'journal-title': 'Advance Data'} / Advance Data / Dietary intake of vitamins, minerals, and fiber of persons ages 2 months and over in the United States by Alaimo (1994)
  90. 10.1007/BF02555919 / Calcif Tissue Int / Calcium intake and bone mass by Cumming (1990)
  91. 10.1093/ajcn/54.1.274S / Am J Clin Nutr / Calcium supplementation and bone loss by Dawson-Hughes (1991)
  92. Holbrook TL, Barrett-Connor E, Wingard DL. Dietary calcium and risk of hip fracture: 14-year prospective population study. Lancet 1988;1046–1049. (10.1016/S0140-6736(88)90065-7)
  93. 10.1097/00001648-199101000-00004 / Epidemiology / Exercise and other factors in the prevention of hip fracture by Paganini-Hill (1991)
  94. 10.7326/0003-4819-115-7-505 / Ann Intern Med / Effect of vitamin D supplementation on wintertime and overall bone loss in healthy postmenopausal women by Dawson-Hughes (1991)
  95. 10.1007/BF00298497 / Calcif Tissue Int / Annual injection of vitamin D and fractures of aged bones by Heikinheimo (1992)
  96. 10.1056/NEJM199212033272305 / N Engl J Med / Vitamin D3 and calcium to prevent hip fractures in elderly women by Chapuy (1992)
  97. 10.7326/0003-4819-115-11-837 / Ann Intern Med / Which fractures are associated with low appendicular bone mass in elderly women? by Seeley (1991)
  98. 10.1056/NEJM198511283132203 / N Engl J Med / Effect of added dietary calcium on colonic epithelial proliferation in subjects at high risk for familial colon cancer by Lipkin (1985)
  99. 10.1016/S0140-6736(85)91082-7 / Lancet / Dietary vitamin D and calcium and risk of colorectal cancer by Garland (1985)
  100. 10.1093/oxfordjournals.aje.a114998 / Am J Epidemiol / Dietary calcium intake as a mitigating factor in colon cancer by Slattery (1988)
  101. 10.1093/oxfordjournals.aje.a116640 / Am J Epidemiol / Relation of calcium, vitamin D, and dairy food intake to incidence of colon cancer among older women by Bostick (1993)
  102. 10.1002/ijc.2910260609 / Int J Cancer / A case-control study of diet and colorectal cancer by Jain (1980)
  103. 10.1093/oxfordjournals.aje.a116931 / Am J Epidemiol / Calcium, vitamin D, dairy foods, and the occurrence of colorectal adenomas among men and women in two prospective studies by Kampman (1994)
  104. 10.1016/S0140-6736(89)91789-3 / Lancet / Serum 25-hydroxyvitamin D and colon cancer by Garland (1989)
  105. 10.1093/oxfordjournals.aje.a117682 / Am J Epidemiol / Colon cancer and serum vitamin D metabolite levels 10–17 years prior to diagnosis by Braun (1995)
  106. 10.1016/S0140-6736(79)92816-2 / Lancet / 1,25-dihydroxyvitamin-D-receptor in breast cancer cells by Eisman (1979)
  107. 10.1016/0140-6736(91)90280-3 / Lancet / Topical calcipotriol treatment in advanced breast cancer by Bower (1991)
  108. 10.1093/ije/19.4.820 / Int J Epidemiol / Sunlight and breast cancer incidence in the USSR by Gorham (1990)
  109. 10.1016/0091-7435(90)90058-R / Prev Med / Geographic variation in breast cancer mortality in the United States by Garland (1990)
  110. 10.1056/NEJM199303253281203 / N Engl J Med / A prospective study of dietary calcium and other nutrients and the risk of symptomatic kidney stones by Curhan (1993)
  111. 10.1161/01.CIR.86.3.1046 / Circulation / Report on the conference on low blood cholesterol by Jacobs (1992)
  112. 10.1016/0197-2456(88)90033-5 / Controlled Clin Trials / Statistical design of the Women’s Health Trial by Self (1988)
  113. Breslow NE, Day NE. Statistical Methods in Cancer Research, Vol 2: The Design and Analysis of Cohort Studies. Lyon, France: IARC Scientific Publication No. 82, International Agency for Research on Cancer; 1987.
  114. 10.1177/096228029500400402 / Stat Meth Med Res / Design issues in cohort studies by Prentice (1995)
  115. {'key': '10.1016/S0197-2456(97)00078-0_BIB115', 'first-page': '519', 'article-title': 'Informed consent in the Women’s Health Initiative clinical trial and observational study', 'volume': '5', 'author': 'McTiernan', 'year': '1996', 'journal-title': 'J Women’s Health'} / J Women’s Health / Informed consent in the Women’s Health Initiative clinical trial and observational study by McTiernan (1996)
  116. 10.1016/S0197-2456(96)00016-5 / Controlled Clin Trials / Approaches to monitoring the results of long-term disease prevention trials by Freedman (1996)
  117. 10.2307/2530245 / Biometrics / A multiple testing procedure for clinical trials by O’Brien (1979)
Dates
Type When
Created 23 years, 1 month ago (July 25, 2002, 8:10 a.m.)
Deposited 2 years, 4 months ago (April 7, 2023, 6:01 p.m.)
Indexed 13 hours, 32 minutes ago (Aug. 31, 2025, 6:26 a.m.)
Issued 27 years, 6 months ago (Feb. 1, 1998)
Published 27 years, 6 months ago (Feb. 1, 1998)
Published Print 27 years, 6 months ago (Feb. 1, 1998)
Funders 0

None

@article{1998, volume={19}, ISSN={0197-2456}, url={http://dx.doi.org/10.1016/s0197-2456(97)00078-0}, DOI={10.1016/s0197-2456(97)00078-0}, number={1}, journal={Controlled Clinical Trials}, publisher={Elsevier BV}, year={1998}, month=feb, pages={61–109} }