This list refers to the citations made over the various pages in the 'CONSORT Statement' section of the website, which replicate the published CONSORT 2010 explanatory document. For more references, please visit the CONSORT Database.

1 Rennie D. CONSORT revised—improving the reporting of randomized trials. JAMA 2001;285:2006-7.
[PMID: 11308440]
2 Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408-12.
[PMID: 7823387]
3 Moher D. CONSORT: an evolving tool to help improve the quality of reports of randomized controlled trials. Consolidated Standards of Reporting Trials. JAMA. 1998;279:1489-91.
[PMID: 0009600488]
4 Kjaergård LL, Villumsen J, Gluud C. Quality of randomised clinical trials affects estimates of intervention efficacy. 1999. Rome, Italy, 7th Cochrane Colloquium. 1999.
5 Jüni P, Altman DG, Egger M. Assessing the quality of controlled clinical trials. BMJ. 2001;323:42-46.
[PMID: 0011440947]
6 Veldhuyzen van Zanten SJ, Cleary C, Talley NJ, Peterson TC, Nyren O, Bradley LA, et al. Drug treatment of functional dyspepsia: a systematic analysis of trial methodology with recommendations for design of future trials. Am J Gastroenterol 1996;91:660-73.
[PMID: 0008677926]
7 Talley NJ, Owen BK, Boyce P, Paterson K. Psychological treatments for irritable bowel syndrome: a critique of controlled treatment trials. Am J Gastroenterol. 1996;91:277-83.
[PMID: 0008607493]
8 Adetugbo K, Williams H. How well are randomized controlled trials reported in the dermatology literature? Arch Dermatol. 2000;136:381-5.
[PMID: 0010724201]
9 Kjaergård LL, Nikolova D, Gluud C. Randomized clinical trials in HEPATOLOGY: predictors of quality. Hepatology. 1999;30:1134-8.
[PMID: 10534332]
10 Schor S, Karten I. Statistical evaluation of medical journal manuscripts. JAMA. 1966;195:1123-8.
[PMID: 0005952081]
11 Gore SM, Jones IG, Rytter EC. Misuse of statistical methods: critical assessment of articles in BMJ from January to March 1976. Br Med J. 1977;1:85-7.
[PMID: 0000832023]
12 Hall JC, Hill D, Watts JM. Misuse of statistical methods in the Australasian surgical literature. Aust N Z J Surg. 1982;52:541-3.
[PMID: 0006959608]
13 Altman DG. Statistics in medical journals. Stat Med. 1982;1:59-71.
[PMID: 0007187083]
14 Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials. A survey of three medical journals. N Engl J Med. 1987;317:426-32.
[PMID: 0003614286]
15 Altman DG. The scandal of poor medical research. BMJ. 1994;308:283-4.
[PMID: 0008124111]
16 Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 2005;365:1159-62.
[PMID: 15794971]
17 Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ 2010;340:c723.
18 Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999;319:670-4.
[PMID: 0010480822]
19 Lai TY, Wong VW, Lam RF, Cheng AC, Lam DS, Leung GM. Quality of reporting of key methodological items of randomized controlled trials in clinical ophthalmic journals. Ophthalmic Epidemiol 2007;14:390-8.
[PMID: 18161613]
20 Moher D, Fortin P, Jadad AR, Jüni P, Klassen T, Le LJ, et al. Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews. Lancet 1996;347:363-6.
[PMID: 0008598702]
21 Junker CA. Adherence to published standards of reporting: a comparison of placebo-controlled trials published in English or German. JAMA 1998;280:247-9.
[PMID: 0009676671]
22 Altman DG. Randomisation. BMJ 1991;302:1481-2.
[PMID: 0001855013]
23 Schulz KF, Chalmers I, Grimes DA, Altman DG. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. JAMA 1994;272:125-8.
[PMID: 0008015122]
24 Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation. BMJ 1948;2:769-82.
[PMID: 18890300]
25 Schulz KF. Randomized controlled trials. Clin Obstet Gynecol 1998;41:245-56.
[PMID: 0009646957]
26 Greenland S. Randomization, statistics, and causal inference. Epidemiology 1990;1:421-9.
[PMID: 2090279]
27 Armitage P. The role of randomization in clinical trials. Stat Med 1982;1:345-52.
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28 Kleijnen J, Gøtzsche PC, Kunz R, Oxman AD, Chalmers I. So what’s so special about randomisation. In: Maynard A, Chalmers I, eds. Non-random reflections on health services research. BMJ Books, 1997:93-106.
29 Chalmers I. Assembling comparison groups to assess the effects of health care. J R Soc Med 1997;90:379-86.
[PMID: 0009290419]
30 Nicolucci A, Grilli R, Alexanian AA, Apolone G, Torri V, Liberati A. Quality, evolution, and clinical implications of randomized, controlled trials on the treatment of lung cancer. A lost opportunity for meta-analysis. JAMA 1989;262:2101-7.
[PMID: 0002677423]
31 Ah-See KW, Molony NC. A qualitative assessment of randomized controlled trials in otolaryngology. J Laryngol Otol 1998;112:460-3.
[PMID: 0009747475]
32 Altman DG, Doré CJ. Randomisation and baseline comparisons in clinical trials. Lancet 1990;335:149-53.
[PMID: 0001967441]
33 Thornley B, Adams C. Content and quality of 2000 controlled trials in schizophrenia over 50 years. BMJ 1998;317:1181-4.
[PMID: 0009794850]
34 DerSimonian R, Charette LJ, McPeek B, Mosteller F. Reporting on methods in clinical trials. N Engl J Med 1982;306:1332-7.
[PMID: 0007070458]
35 The Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials. JAMA 1994;272:1926-31.
[PMID: 0007990245]
36 Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Ann Intern Med 1994;121:894-5.
[PMID: 0007978706]
37 Rennie D. Reporting randomized controlled trials. An experiment and a call for responses from readers. JAMA 1995;273:1054-5.
[PMID: 0007897791]
38 Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996;276:637-9.
[PMID: 0008773637]
39 Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006;295:1152-60.
[PMID: 16522836]
40 Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004;328:702-8.
[PMID: 15031246]
41 Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008;337:a2390.
[PMID: 19001484]
42 Ioannidis JP, Evans SJ, Gøtzsche PC, O’Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781-8.
[PMID: 15545678]
43 Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008;148:295-309.
[PMID: 18283207]
44 Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med 2006;144:364-7.
[PMID: 16520478]
45 Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med 2008;5:e20.
[PMID: 18215107]

46 Siegel JE, Weinstein MC, Russell LB, Gold MR. Recommendations for reporting cost-effectiveness analyses. Panel on Cost-Effectiveness in Health and Medicine. JAMA 1996;276:1339-41.
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47 Drummond MF, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. The BMJ Economic Evaluation Working Party. BMJ. 1996;313:275-83. [PMID: 0008704542]
48 Lang TA, Secic M. How to report statistics in medicine. Annotated guidelines for authors, editors, and reviewers. ACP, 1997.
49 Davidoff F. News from the International Committee of Medical Journal Editors. Ann Intern Med 2000;133:229-31.
[PMID: 0010906840]
50 Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust 2006;185:263-7.
[PMID: 16948622]
51 Egger M, Jüni P, Bartlett C. Value of flow diagrams in reports of randomized controlled trials. JAMA 2001;285:1996-9.
[PMID: 11308437]
52 Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med 2001;134:657-62.
[PMID: 11304106]
53 Moher D, Schulz KF, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001;285:1987-91.
[PMID: 11308435]
54 Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001;357:1191-4.
[PMID: 11323066]
55 Chan AW, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004;291:2457-65.
[PMID: 15161896]
56 Al-Marzouki S, Roberts I, Evans S, Marshall T. Selective reporting in clinical trials: analysis of trial protocols accepted by the Lancet. Lancet 2008;372:201.
[PMID: 18640445]
57 Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS ONE 2008;3:e3081.
[PMID: 18769481]
58 Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001;134:663-94.
[PMID: 11304107]
59 Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.
60 Pocock SJ. Clinical trials: a practical approach. John Wiley, 1983.
61 Meinert CL. Clinical trials: design, conduct and analysis. Oxford University Press, 1986.
62 Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials. 3rd ed. Springer, 1998.
63 Bolliger CT, Zellweger JP, Danielsson T, et al. Smoking reduction with oral nicotine inhalers: double blind, randomised clinical trial of efficacy and safety. BMJ. 2000;321:329-33.
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64 Dickersin K, Manheimer E, Wieland S, Robinson KA, Lefebvre C, McDonald S. Development of the Cochrane Collaboration’s CENTRAL Register of controlled clinical trials. Eval Health Prof 2002;25:38-64.
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65 Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet 2008;371:281-3.
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66 The impact of open access upon public health. PLoS Med 2006;3:e252.
67 Harbourt AM, Knecht LS, Humphreys BL. Structured abstracts in MEDLINE, 1989-1991. Bull Med Libr Assoc 1995;83:190-5.
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68 Harris AH, Standard S, Brunning JL, Casey SL, Goldberg JH, Oliver L, et al. The accuracy of abstracts in psychology journals. J Psychol 2002;136:141-8.
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69 Pitkin RM, Branagan MA, Burmeister LF. Accuracy of data in abstracts of published research articles. JAMA 1999;281:1110-1.
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70 Ward LG, Kendrach MG, Price SO. Accuracy of abstracts for original research articles in pharmacy journals. Ann Pharmacother 2004;38:1173-7.
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71 Gøtzsche PC. Believability of relative risks and odds ratios in abstracts: cross sectional study. BMJ 2006;333:231-4.
[PMID: 16854948]
72 Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA 2001;285:437-43.
[PMID: 11242428]
73 Haynes RB, Mulrow CD, Huth EJ, Altman DG, Gardner MJ. More informative abstracts revisited. Ann Intern Med 1990;113:69-76.
[PMID: 0002190518]
74 Taddio A, Pain T, Fassos FF, Boon H, Ilersich AL, Einarson TR. Quality of nonstructured and structured abstracts of original research articles in the British Medical Journal, the Canadian Medical Association Journal and the Journal of the American Medical Association. CMAJ. 1994;150:1611-5.
[PMID: 0008174031]

75 Haynes RB, Mulrow CD, Huth EJ, Altman DG, Gardner MJ. More informative abstracts revisited. Ann Intern Med. 1990;113:69-76.
[PMID: 0002190518]

76 Hartley J, Sydes M, Blurton A. Obtaining information accurately and quickly: Are structured abstracts more efficient? J Inform Sci 1996;22:349-56.
77 Gilligan D, Nicolson M, Smith I, Groen H, Dalesio O, Goldstraw P, et al. Preoperative chemotherapy in patients with resectable non-small cell lung cancer: results of the MRC LU22/NVALT 2/EORTC 08012 multicentre randomised trial and update of systematic review. Lancet 2007;369:1929-37.
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78 Sandler AD, Sutton KA, DeWeese J, Girardi MA, Sheppard V, Bodfish JW. Lack of benefit of a single dose of synthetic human secretin in the treatment of autism and pervasive developmental disorder. N Engl J Med. 1999;341:1801-6.
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79 World Medical Association. Declaration of Helsinki: ethical principle for medical research involving human subjects. 59th WMA General Assembly, Seoul 2008; (accessed 2 June 2009).
80 Lau J, Antman EM, Jimenez-Silva J, Kupelnick B, Mosteller F, Chalmers TC. Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med. 1992;327:248-54.
[PMID: 0001614465]

81 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;2:218-29.
[PMID: 16279145]
82 Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ. 1996;313:1390-3.
[PMID: 0008956711]

83 Sadler LC, Davison T, McCowan LM. A randomised controlled trial and meta-analysis of active management of labour. BJOG. 2000;107:909-15.
[PMID: 0010901564]
84 Bath FJ, Owen VE, Bath PM. Quality of full and final publications reporting acute stroke trials: a systematic review. Stroke 1998;29:2203-10.
[PMID: 0009756604]
85 Blumer JL, Findling RL, Shih WJ, Soubrane C, Reed MD. Controlled clinical trial of zolpidem for the treatment of insomnia associated with attention-deficit/hyperactivity disorder in children 6 to 17 years of age. Pediatrics 2009;123:e770-e776.
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86 Sabatine MS, Antman EM, Widimsky P, Ebrahim IO, Kiss RG, Saaiman A, et al. Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes (SEPIA-ACS1 TIMI 42): a randomised, double-blind, active-controlled, phase 2 trial. Lancet 2009;374:787-95.
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87 Grant AM, Altman DG, Babiker AB, Campbell MK, Clemens FJ, Darbyshire JH, et al. Issues in data monitoring and interim analysis of trials. Health Technol Assess 2005;9:1-iv.
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88 Gallo P, Krams M. PhRMA Working Group on adaptive designs, “White Paper.” Drug Information Journal 2006;40:421-82.
89 Brown CH, Ten Have TR, Jo B, Dagne G, Wyman PA, Muthen B, et al. Adaptive designs for randomized trials in public health. Annu Rev Public Health 2009;30:1-25.
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90 Kelly PJ, Sooriyarachchi MR, Stallard N, Todd S. A practical comparison of group-sequential and adaptive designs. J Biopharm Stat 2005;15:719-38.
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91 Pildal J, Chan AW, Hróbjartsson A, Forfang E, Altman DG, Gøtzsche PC. Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study. BMJ 2005;330:1049.
[PMID: 15817527]
92 Chan AW, Hróbjartsson A, Jørgensen KJ, Gøtzsche PC, Altman DG. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. BMJ 2008;337:a2299.
[PMID: 19056791]
93 Ndekha MJ, van Oosterhout JJ, Zijlstra EE, Manary M, Saloojee H, Manary MJ. Supplementary feeding with either ready-to-use fortified spread or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: randomised, investigator blinded, controlled trial. BMJ 2009;338:1867-75.
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94 Rothwell PM. External validity of randomised controlled trials: “to whom do the results of this trial apply?” Lancet 2005;365:82-93.
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95 Fuks A, Weijer C, Freedman B, Shapiro S, Skrutkowska M, Riaz A. A study in contrasts: eligibility criteria in a twenty-year sample of NSABP and POG clinical trials. National Surgical Adjuvant Breast and Bowel Program. Pediatric Oncology Group. J Clin Epidemiol. 1998;51:69-79.
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96 Shapiro SH, Weijer C, Freedman B. Reporting the study populations of clinical trials. Clear transmission or static on the line? J Clin Epidemiol. 2000;53:973-9.
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97 Gandhi M, Ameli N, Bacchetti P, Sharp GB, French AL, Young M, et al. Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols. AIDS 2005;19:1885-96.
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98 Hall JC, Mills B, Nguyen H, Hall JL. Methodologic standards in surgical trials. Surgery. 1996;119:466-72.
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99 Weiss NS, Koepsell TD, Psaty BM. Generalizability of the results of randomized trials. Arch Intern Med 2008;168:133-5.
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100 Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet 2008;371:1839-47.
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101 Rannou F, Dimet J, Boutron I, Baron G, Fayad F, Macé Y, et al. Splint for base-of-thumb osteoarthritis: a randomized trial. Ann Intern Med 2009;150:661-9.
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102 Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing from descriptions of treatment in trials and reviews? BMJ 2008;336:1472-4.
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103 Mease PJ, Goffe BS, Metz J, VanderStoep A, Finck B, Burge DJ. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial. Lancet. 2000;356:385-90.
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104 McDowell I, Newell C. Measuring health: a guide to rating scales and questionnaires. 3rd ed. New York: Oxford University Press, 2006.
105 Streiner D, Norman C. Health measurement scales: a practical guide to their development and use. 3rd ed. Oxford: Oxford University Press; 2003.
106 Clarke M. Standardising outcomes for clinical trials and systematic reviews. Trials 2007;8:39.
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107 Sanders C, Egger M, Donovan J, Tallon D, Frankel S. Reporting on quality of life in randomised controlled trials: bibliographic study. BMJ. 1998;317:1191-4.
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108 Gøtzsche PC. Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Control Clin Trials 1989;10:31-56.
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109 Marshall M, Lockwood A, Bradley C, Adams C, Joy C, Fenton M. Unpublished rating scales: a major source of bias in randomised controlled trials of treatments for schizophrenia. Br J Psychiatry. 2000;176:249-52.
[PMID: 0010755072]

110 Jadad AR, Boyle M, Cunnigham C, Kim M, Schachar R. Treatment of Attention-Deficit/Hyperactivity Disorder. Evidence Report/Technology Assessment No. 11. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, Agency for Healthcare Research and Quality. AHQR publication no. 00-E005; 1999.
111 Schachter HM, Pham B, King J, Langford S, Moher D. The efficacy and safety of methylphenidate in attention deficit disorder: A systematic review and meta-analysis. Prepared for the Therapeutics Initiative, Vancouver, B.C., and the British Columbia Ministry for Children and Families, 2000.
112 Dargie HJ. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet 2001;357:1385-90.
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113 Chan AW, Krleza-Jerić K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ 2004;171:735-40.
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114 Vermeulen H, Hofland J, Legemate DA, Ubbink DT. Intravenous fluid restriction after major abdominal surgery: a randomized blinded clinical trial. Trials 2009;10:50.
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115 Fox K, Ford I, Steg PG, Tendera M, Ferrari R. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet 2008;372:807-16.
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116 Campbell MJ, Julious SA, Altman DG. Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons. BMJ. 1995;311:1145-8.
[PMID: 0007580713]

117 Guyatt GH, Mills EJ, Elbourne D. In the era of systematic reviews, does the size of an individual trial still matter. PLoS Med 2008;5:e4.
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118 Schulz KF, Grimes DA. Sample size calculations in randomised trials: mandatory and mystical. Lancet 2005;365:1348-53.
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119 Halpern SD, Karlawish JH, Berlin JA. The continuing unethical conduct of underpowered clinical trials. JAMA 2002;288:358-62.
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120 Altman DG, Bland JM. Absence of evidence is not evidence of absence. BMJ. 1995;311:485
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121 Moher D, Dulberg CS, Wells GA. Statistical power, sample size, and their reporting in randomized controlled trials. JAMA 1994;272:122-4.
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122 Freiman JA, Chalmers TC, Smith HJ, Kuebler RR. The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 "negative" trials. N Engl J Med. 1978;299:690-4.
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123 Charles P, Giraudeau B, Dechartres A, Baron G, Ravaud P. Reporting of sample size calculation in randomised controlled trials: review. BMJ 2009;338:b1732.
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124 Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials? Stat Med. 1984;3:409-22.
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125 Goodman SN, Berlin JA. The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Ann Intern Med. 1994;121:200-6.
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126 Galgiani JN, Catanzaro A, Cloud GA, et al. Comparison of Oral Fluconazole and Itraconazole for Progressive, Nonmeningeal Coccidioidomycosis. A Randomized, Double-Blind Trial. Ann Intern Med. 2000;133:676-86.
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127 Connolly SJ, Pogue J, Hart RG, Hohnloser SH, Pfeffer M, Chrolavicius S, et al. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med 2009;360:2066-78.
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128 Geller NL, Pocock SJ. Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners. Biometrics. 1987;43:213-23.
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129 Berry DA. Interim analyses in clinical trials: classical vs. Bayesian approaches. Stat Med. 1985;4:521-6.
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130 Pocock SJ. When to stop a clinical trial. BMJ. 1992;305:235-40.
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131 DeMets DL, Pocock SJ, Julian DG. The agonising negative trend in monitoring of clinical trials. Lancet. 1999;354:1983-8.
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132 Buyse M. Interim analyses, stopping rules and data monitoring in clinical trials in Europe. Stat Med. 1993;12:509-20.
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133 Sydes MR, Altman DG, Babiker AB, Parmar MK, Spiegelhalter DJ. Reported use of data monitoring committees in the main published reports of randomized controlled trials: a cross-sectional study. Clin Trials 2004;1:48-59.
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134 Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, et al. Randomized trials stopped early for benefit: a systematic review. JAMA 2005;294:2203-9.
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135 Coutinho IC, Ramos de Amorim MM, Katz L, Bandeira de Ferraz AA. Uterine exteriorization compared with in situ repair at cesarean delivery: a randomized controlled trial. Obstet Gynecol 2008;111:639-47.
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136 Jüni P, Altman DG, Egger M. Assessing the quality of controlled clinical trials. In: Egger M, Davey Smith G, Altman DG, eds. Systematic reviews in health care: meta-analysis in context. BMJ Books, 2001.
137 Creinin MD, Meyn LA, Borgatta L, Barnhart K, Jensen J, Burke AE, et al. Multicenter comparison of the contraceptive ring and patch: a randomized controlled trial. Obstet Gynecol 2008;111:267-77.
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138 Tate DF, Jackvony EH, Wing RR. Effects of internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: a randomized trial. JAMA 2003;289:1833-6.
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139 Lachin JM. Properties of simple randomization in clinical trials. Control Clin Trials 1988;9:312-26.
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140 Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 1976;34:585-612.
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141 Schulz KF, Grimes DA. The Lancet handbook of essential concepts in clinical research. Elsevier, 2006.
142 Altman DG, Bland JM. How to randomise. BMJ. 1999;319:703-4.
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143 Schulz KF. Subverting randomization in controlled trials. JAMA. 1995;274:1456-8.
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144 Enas GG, Enas NH, Spradlin CT, Wilson MG, Wiltse CG. Baseline comparability in clinical trials: prevention of poststudy anxiety. Drug Information Journal 1990;24:541-8.
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