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Volumn , Issue , 2011, Pages

Randomized Clinical Trials: Design, Practice and Reporting

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EID: 84891584135     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470686232     Document Type: Book
Times cited : (30)

References (193)
  • 1
    • 0026055728 scopus 로고
    • Chemotherapy in advanced ovarian cancer: an overview of randomised clinical trials
    • Advanced Ovarian Trialist Group
    • Advanced Ovarian Trialist Group (1991) Chemotherapy in advanced ovarian cancer: an overview of randomised clinical trials. BMJ, 303, 884-893. [14]
    • (1991) BMJ , vol.303 , pp. 884-893
  • 2
    • 0000438257 scopus 로고    scopus 로고
    • Randomised crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer pain
    • Allan, L., Hays, H., Jensen, N.-H., de Waroux, B.L.P., Bolt, M., Donald, R. and Kalso, E. (2008) Randomised crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer pain. BMJ, 322, 1-7. [12]
    • (2008) BMJ , vol.322 , pp. 1-7
    • Allan, L.1    Hays, H.2    Jensen, N.-H.3    De Waroux, B.L.P.4    Bolt, M.5    Donald, R.6    Kalso, E.7
  • 3
    • 0025063463 scopus 로고
    • Chemo-radiotherapy in patients with locally advanced nasopharyngeal carcinoma: a radiation therapy oncology group study
    • Al-Sarraf, M., Pajak, P.F., Cooper, J.S., Mohiuddin, M., Herskovic, A. and Ager, P.J. (1990) Chemo-radiotherapy in patients with locally advanced nasopharyngeal carcinoma: a radiation therapy oncology group study. Journal of Clinical Oncology, 8, 1342-1351. [2]
    • (1990) Journal of Clinical Oncology , vol.8 , pp. 1342-1351
    • Al-Sarraf, M.1    Pajak, P.F.2    Cooper, J.S.3    Mohiuddin, M.4    Herskovic, A.5    Ager, P.J.6
  • 4
    • 0003415539 scopus 로고
    • Practical Statistics for Medical Research
    • Chapman and Hall, London
    • Altman, D.G., (1991) Practical Statistics for Medical Research. Chapman and Hall, London. [8]
    • (1991) , pp. 8
    • Altman, D.G.1
  • 5
    • 0002925659 scopus 로고    scopus 로고
    • Statistical guidelines for contributors to medical journals
    • In Statistics with Confidence, 2nd edn (eds D.G. Altman, D. Machin, T.N. Bryant and M.J. Gardner), London
    • Altman, D.G., Gore, S.M., Gardner, M.J. and Pocock, S.J. (2000) Statistical guidelines for contributors to medical journals. In Statistics with Confidence, 2nd edn (eds D.G. Altman, D. Machin, T.N. Bryant and M.J. Gardner), British Medical Journal, London, 171-190. [10]
    • (2000) British Medical Journal
    • Altman, D.G.1    Gore, S.M.2    Gardner, M.J.3    Pocock, S.J.4
  • 6
    • 0004280149 scopus 로고    scopus 로고
    • Statistics With Confidence
    • 2nd edn, London
    • Altman, D.G., Machin, D., Bryant, T.N. and Gardner, M.J. (eds) (2000) Statistics With Confidence, 2nd edn, British Medical Journal, London. [8]
    • (2000) , pp. 8
    • Altman, D.G.1    Machin, D.2    Bryant, T.N.3    Gardner, M.J.4
  • 8
    • 0035815002 scopus 로고    scopus 로고
    • Evaluating the role of alternative therapy in burn wound management: randomized trial comparing Moist Exposed Burn Ointment with conventional methods in the management of patients with second-degree burns
    • Ang, E.S.-W., Lee, S.-T., Gan, C.S.-G., See, P.G.-J., Chan, Y.-H., Ng, L.-H. and Machin, D., (2001) Evaluating the role of alternative therapy in burn wound management: randomized trial comparing Moist Exposed Burn Ointment with conventional methods in the management of patients with second-degree burns. Medscape General Medicine, 3 (2), 3. [2, 7, 12]
    • (2001) Medscape General Medicine , vol.3 , Issue.2
    • Ang, E.S.-W.1    Lee, S.-T.2    Gan, C.S.-G.3    See, P.G.-J.4    Chan, Y.-H.5    Ng, L.-H.6    Machin, D.7
  • 9
    • 0141595985 scopus 로고    scopus 로고
    • Pain control in a randomized controlled trial comparing Moist Exposed Burn Ointment (MEBO) and conventional methods in patients with partial thickness burns
    • Ang, E.S.-W., Lee, S.-T., Gan, C.S.-G., Chan, Y.-H., Cheung, Y.-B. and Machin, D. (2003) Pain control in a randomized controlled trial comparing Moist Exposed Burn Ointment (MEBO) and conventional methods in patients with partial thickness burns. Journal of Burn Care and Rehabilitation, 24, 289-296. [4, 7]
    • (2003) Journal of Burn Care and Rehabilitation , vol.24 , pp. 289-296
    • Ang, E.S.-W.1    Lee, S.-T.2    Gan, C.S.-G.3    Chan, Y.-H.4    Cheung, Y.-B.5    Machin, D.6
  • 10
    • 0029384514 scopus 로고
    • Retention and caries preventive effects of a GIC and a resinbased fissure sealant
    • Arrow, P. and Riordan, P.J. (1995) Retention and caries preventive effects of a GIC and a resinbased fissure sealant. Community Dentistry and Oral Epidemiology, 23, 282-285. [12]
    • (1995) Community Dentistry and Oral Epidemiology , vol.23 , pp. 282-285
    • Arrow, P.1    Riordan, P.J.2
  • 11
    • 0037157603 scopus 로고    scopus 로고
    • Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial
    • ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists' Group
    • ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists' Group (2002) Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet, 359, 2131-2139. [14]
    • (2002) Lancet , vol.359 , pp. 2131-2139
  • 13
    • 43849084661 scopus 로고    scopus 로고
    • Enhanced diabetes care to patients of south Asian ethnic origin (the United Kingdom Asian Diabetes Study): a cluster randomised trial
    • Bellary, S., O'Hare, J.P., Raymond, N.T., Gumber, A., Mughal, S. , Szczepura, A. , Kumar, S. and Barnett, A.H. (2008) Enhanced diabetes care to patients of south Asian ethnic origin (the United Kingdom Asian Diabetes Study): a cluster randomised trial. Lancet, 371, 1769-1776. [11]
    • (2008) Lancet , vol.371 , pp. 1769-1776
    • Bellary, S.1    O'Hare, J.P.2    Raymond, N.T.3    Gumber, A.4    Mughal, S.5    Szczepura, A.6    Kumar, S.7    Barnett, A.H.8
  • 14
    • 0031752245 scopus 로고    scopus 로고
    • Prerandomization of clinical trials: a more ethical way for performing cleft palate research
    • Berkowitz, S. (1998). Prerandomization of clinical trials: a more ethical way for performing cleft palate research. Plastic and Reconstructive Surgery, 102, 1724. [14]
    • (1998) Plastic and Reconstructive Surgery , vol.102
    • Berkowitz, S.1
  • 15
    • 84887175925 scopus 로고    scopus 로고
    • Power & precision: release 2.1
    • Biostat, Englewood, NJ
    • Biostat (2001) Power & precision: release 2.1, Englewood, NJ. [9]
    • (2001) , pp. 9
  • 16
    • 0028595559 scopus 로고
    • Internal pilot studies for estimating sample size
    • Birkett, M.A. and Day, S.J. (1994) Internal pilot studies for estimating sample size. Statistics in Medicine, 13, 2455-2463. [7]
    • (1994) Statistics in Medicine , vol.13 , pp. 2455-2463
    • Birkett, M.A.1    Day, S.J.2
  • 18
    • 84887185491 scopus 로고    scopus 로고
    • BMJ, Editors' checklist
    • BMJ (2006) Editors' checklist, www.bmj.com/advice/checklists.shtml. [10]
    • (2006) , pp. 10
  • 19
    • 40049106691 scopus 로고    scopus 로고
    • Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration
    • Boutron, I., Moher, D., Altman, D.G., Schultz, K.F. and Ravaud, P. (2008) Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Annals of Internal Medicine, 148, 295-309. [10]
    • (2008) Annals of Internal Medicine , vol.148 , pp. 295-309
    • Boutron, I.1    Moher, D.2    Altman, D.G.3    Schultz, K.F.4    Ravaud, P.5
  • 20
    • 0042735106 scopus 로고    scopus 로고
    • Survival analysis part III: multivariate data analysis-choosing a model and assessing its adequacy and fit
    • Bradburn, M.J., Clark, T.G., Love, S.B. and Altman, D.G. (2003) Survival analysis part III: multivariate data analysis-choosing a model and assessing its adequacy and fit. British Journal of Cancer, 89, 605-611. [10]
    • (2003) British Journal of Cancer , vol.89 , pp. 605-611
    • Bradburn, M.J.1    Clark, T.G.2    Love, S.B.3    Altman, D.G.4
  • 22
    • 0034736557 scopus 로고    scopus 로고
    • Some practical issues in the design, monitoring and analysis of a sequential randomized trial in pressure sore prevention
    • Brown, J., McElvenny, D., Nixon, J., Bainbridge, J. and Mason, S. (2000) Some practical issues in the design, monitoring and analysis of a sequential randomized trial in pressure sore prevention. Statistics in Medicine, 19, 3389-3400. [4, 14]
    • (2000) Statistics in Medicine , vol.19 , pp. 3389-3400
    • Brown, J.1    McElvenny, D.2    Nixon, J.3    Bainbridge, J.4    Mason, S.5
  • 23
    • 0002711341 scopus 로고    scopus 로고
    • Computer software for calculating confidence intervals (CIA) In Statistics with Confidence
    • 2nd edn (eds D.G. Altman, D. Machin, T.N. Bryant and M.J. Gardner), London
    • Bryant, T.N. (2000) Computer software for calculating confidence intervals (CIA) In Statistics with Confidence, 2nd edn (eds D.G. Altman, D. Machin, T.N. Bryant and M.J. Gardner), British Medical Journal, London, pp. 208-213. [10]
    • (2000) British Medical Journal
    • Bryant, T.N.1
  • 24
    • 0037425745 scopus 로고    scopus 로고
    • Combined salmeterol and flucticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial
    • Calverley, P., Pauwels, R., Vestbo, J., Jones, P., Pride, N., Gulsvik, A., Anderson, J. and Maden, C. (2003) Combined salmeterol and flucticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet, 361, 449-456. [13]
    • (2003) Lancet , vol.361 , pp. 449-456
    • Calverley, P.1    Pauwels, R.2    Vestbo, J.3    Jones, P.4    Pride, N.5    Gulsvik, A.6    Anderson, J.7    Maden, C.8
  • 25
    • 0041409720 scopus 로고    scopus 로고
    • A randomised trial of cranberry versus apple juice in the management of urinary symptoms during external beam radiation therapy for prostate cancer
    • Campbell, G., Pickles, T. and D'yachkova, Y. (2003) A randomised trial of cranberry versus apple juice in the management of urinary symptoms during external beam radiation therapy for prostate cancer. Clinical Oncology, 15, 322-328. [5]
    • (2003) Clinical Oncology , vol.15 , pp. 322-328
    • Campbell, G.1    Pickles, T.2    D'yachkova, Y.3
  • 27
    • 0033885182 scopus 로고    scopus 로고
    • Cluster randomized trials in general (family) practice research
    • Campbell, M.J. (2000) Cluster randomized trials in general (family) practice research. Statistical Methods in Medical Research, 9, 81-94. [11]
    • (2000) Statistical Methods in Medical Research , vol.9 , pp. 81-94
    • Campbell, M.J.1
  • 28
    • 84887192821 scopus 로고    scopus 로고
    • Medians and their differences. In Statistics with Confidence
    • 2nd edn (eds D.G. Altman, D. Machin, T.N. Bryant and M.J. Gardner), London
    • Campbell, M.J. and Gardner, M.J. (2000) Medians and their differences. In Statistics with Confidence, 2nd edn (eds D.G. Altman, D. Machin, T.N. Bryant and M.J. Gardner), British Medical Journal, London. [8]
    • (2000) British Medical Journal , pp. 8
    • Campbell, M.J.1    Gardner, M.J.2
  • 29
    • 0003832677 scopus 로고    scopus 로고
    • Medical Statistics: a Commonsense Approach: a Text Book for the Health Sciences
    • 4th edn, John Wiley & Sons, Ltd, Chichester
    • Campbell, M.J., Machin, D. and Walters, S.J. (2007) Medical Statistics: a Commonsense Approach: a Text Book for the Health Sciences, 4th edn, John Wiley & Sons, Ltd, Chichester. [8]
    • (2007) , pp. 8
    • Campbell, M.J.1    Machin, D.2    Walters, S.J.3
  • 30
    • 1642400145 scopus 로고    scopus 로고
    • The CONSORT statement: extension to cluster randomised trials
    • for the CONSORT Group
    • Campbell, M.K., Elbourne, D.R. and Altman, D.G. for the CONSORT Group (2004) The CONSORT statement: extension to cluster randomised trials. British Medical Journal, 328, 702-708. [10]
    • (2004) British Medical Journal , vol.328 , pp. 702-708
    • Campbell, M.K.1    Elbourne, D.R.2    Altman, D.G.3
  • 31
    • 18344392070 scopus 로고    scopus 로고
    • Determinants of the intracluster correlation coefficient in cluster randomised trials
    • Campbell, M.K., Fayers, P.M. and Grimshaw, J.M. (2005) Determinants of the intracluster correlation coefficient in cluster randomised trials. Clinical Trials, 2, 99-107. [11]
    • (2005) Clinical Trials , vol.2 , pp. 99-107
    • Campbell, M.K.1    Fayers, P.M.2    Grimshaw, J.M.3
  • 32
    • 27644531361 scopus 로고    scopus 로고
    • Early intravenous then oral metoprolol in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial
    • Chen, Z.M., Pan, H.C., Chen, Y.P., Peto, R., Collins, R., Jiang, L.X., Xie, J.X., Liu, L.S. (2005) Early intravenous then oral metoprolol in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet, 366, 1622-1632. [14]
    • (2005) Lancet , vol.366 , pp. 1622-1632
    • Chen, Z.M.1    Pan, H.C.2    Chen, Y.P.3    Peto, R.4    Collins, R.5    Jiang, L.X.6    Xie, J.X.7    Liu, L.S.8
  • 33
    • 0036830308 scopus 로고    scopus 로고
    • No role for high-dose tamoxifen in the treatment of inoperable hepatocellular carcinoma: an Asia-Pacific double-blind randomised controlled trial
    • Chow, P.K.-H., Tai, B.-C., Tan, C.-K., Machin, D., Johnson, P.J., Khin, M.-W. and Soo, K.-C. (2002) No role for high-dose tamoxifen in the treatment of inoperable hepatocellular carcinoma: an Asia-Pacific double-blind randomised controlled trial. Hepatology, 36, 1221-1226. [2, 3, 5, 10]
    • (2002) Hepatology , vol.36 , pp. 1221-1226
    • Chow, P.K.-H.1    Tai, B.-C.2    Tan, C.-K.3    Machin, D.4    Johnson, P.J.5    Khin, M.-W.6    Soo, K.-C.7
  • 34
    • 84890648770 scopus 로고    scopus 로고
    • The Cochrane Collaboration
    • In Textbook of Clinical Trials, Chapter 3, 2nd edn (eds D. Machin, S. Day and S. Green), John Wiley & Sons, Ltd, Chichester
    • Clarke,M. (2006) The Cochrane Collaboration. In Textbook of Clinical Trials, Chapter 3, 2nd edn (eds D. Machin, S. Day and S. Green), John Wiley & Sons, Ltd, Chichester, pp. 39-46. [14]
    • (2006)
    • Clarke, M.1
  • 35
    • 34247860590 scopus 로고    scopus 로고
    • Reports of clinical trials should begin and end with up-to-date systematic reviews of the other relevant evidence: a status report
    • Clarke, M., Hopewell, S. and Chalmers, I. (2007) Reports of clinical trials should begin and end with up-to-date systematic reviews of the other relevant evidence: a status report. Journal of the Royal Society of Medicine, 100, 187-190. [14]
    • (2007) Journal of the Royal Society of Medicine , vol.100 , pp. 187-190
    • Clarke, M.1    Hopewell, S.2    Chalmers, I.3
  • 36
    • 0003577917 scopus 로고
    • Statistical Power Analysis for the Behavioral Sciences
    • 2nd edn, Lawrence Erlbaum, New Jersey
    • Cohen, J. (1988) Statistical Power Analysis for the Behavioral Sciences, 2nd edn, Lawrence Erlbaum, New Jersey. [9, 10, 12, 11, 13]
    • (1988) , pp. 9-13
    • Cohen, J.1
  • 37
    • 45249107267 scopus 로고    scopus 로고
    • Effect of laquinimod on MRImonitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study
    • Comi, G., Pulizzi, A., Rovaris, M., Abramsky, O., Arbizu, T., Boiko, A., Gold, R., Havrdova, E., Komoly, S., Selmaj, K.W., Sharrack, B. and Filippi, M. (2008) Effect of laquinimod on MRImonitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study. Lancet, 371, 2085-2092. [4, 10]
    • (2008) Lancet , vol.371 , pp. 2085-2092
    • Comi, G.1    Pulizzi, A.2    Rovaris, M.3    Abramsky, O.4    Arbizu, T.5    Boiko, A.6    Gold, R.7    Havrdova, E.8    Komoly, S.9    Selmaj, K.W.10    Sharrack, B.11    Filippi, M.12
  • 38
    • 0000336139 scopus 로고
    • Regression models and life tables (with discussion)
    • Cox, D.R. (1972) Regression models and life tables (with discussion). Journal of the Royal Statistical Society B, 34, 187-220. [1]
    • (1972) Journal of the Royal Statistical Society B , vol.34 , pp. 187-220
    • Cox, D.R.1
  • 39
    • 0029147608 scopus 로고
    • Biostatistical methodology in clinical trials in applications for marketing authorizations for medicinal products
    • CPMP Working Party on Efficacy of Medicinal Products
    • CPMP Working Party on Efficacy of Medicinal Products (1995) Biostatistical methodology in clinical trials in applications for marketing authorizations for medicinal products. Statistics in Medicine, 14, 1659-1682. [14]
    • (1995) Statistics in Medicine , vol.14 , pp. 1659-1682
  • 40
    • 55549083502 scopus 로고    scopus 로고
    • Developing and evaluating complex interventions: the new Medical Research Council guidance
    • Craig, P., Dieppe, P.P., Macintyre, S., Mitchie, S., Nazarath, I. and Petticrew, M. (2008) Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ, 337, 979-983. [2]
    • (2008) BMJ , vol.337 , pp. 979-983
    • Craig, P.1    Dieppe, P.P.2    Macintyre, S.3    Mitchie, S.4    Nazarath, I.5    Petticrew, M.6
  • 41
    • 0034016768 scopus 로고    scopus 로고
    • Late results of a randomized clinical trial comparing total fundoplication versus calibration of the cardia with posterior gastropexy
    • Csendes, A., Burdiles, P., Korn, O., Braghetto, I., Huertas, C. and Rojas, J. (2002) Late results of a randomized clinical trial comparing total fundoplication versus calibration of the cardia with posterior gastropexy. British Journal of Surgery, 87, 289-297. [5]
    • (2002) British Journal of Surgery , vol.87 , pp. 289-297
    • Csendes, A.1    Burdiles, P.2    Korn, O.3    Braghetto, I.4    Huertas, C.5    Rojas, J.6
  • 42
  • 43
    • 13844318810 scopus 로고    scopus 로고
    • A proposed charter for clinical trial data monitoring committees: helping them to do their job well
    • DAMOCLES Study Group
    • DAMOCLES Study Group (2005) A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet, 365, 711-722. [7]
    • (2005) Lancet , vol.365 , pp. 711-722
  • 44
    • 0004082718 scopus 로고    scopus 로고
    • Dictionary for Clinical Trials
    • 2nd edn, John Wiley & Sons, Ltd, Chichester
    • Day, S. (2007) Dictionary for Clinical Trials, 2nd edn, John Wiley & Sons, Ltd, Chichester. [1, 3, 6]
    • (2007) , pp. 1-6
    • Day, S.1
  • 45
    • 62849089952 scopus 로고    scopus 로고
    • An open mind on adaptive designs
    • GCPj, December, Informa UK Ltd
    • Day, S. and Småstuen, M. (2008) An open mind on adaptive designs. GCPj, December, Informa UK Ltd, pp. 19-22, www.GCPj.com.
    • (2008) , pp. 19-22
    • Day, S.1    Småstuen, M.2
  • 49
    • 0003774549 scopus 로고    scopus 로고
    • Design and Analysis of Cluster Randomised Trials
    • Edward Arnold, London
    • Donner, A. and Klar, N. (2000) Design and Analysis of Cluster Randomised Trials, Edward Arnold, London. [11]
    • (2000) , pp. 11
    • Donner, A.1    Klar, N.2
  • 50
    • 53249142132 scopus 로고    scopus 로고
    • Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study
    • for the DURATION-1 Study Group
    • Drucker, D.J., Buse, J.B., Taylor, K., Kendall, D.M., Trautmann, M. and Zhuang, D., for the DURATION-1 Study Group. (2008) Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet, 372, 1240-1250. [10]
    • (2008) Lancet , vol.372 , pp. 1240-1250
    • Drucker, D.J.1    Buse, J.B.2    Taylor, K.3    Kendall, D.M.4    Trautmann, M.5    Zhuang, D.6
  • 52
    • 0033594688 scopus 로고    scopus 로고
    • Ethical issues in the design and conduct of cluster randomised controlled trials
    • Edwards, S.J.L., Braunholtz, D.A., Lilford, R.J. and Stevens, A.J. (1999) Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ, 318, 1407-1409. [11]
    • (1999) BMJ , vol.318 , pp. 1407-1409
    • Edwards, S.J.L.1    Braunholtz, D.A.2    Lilford, R.J.3    Stevens, A.J.4
  • 53
    • 0003883740 scopus 로고    scopus 로고
    • Systematic Reviews in Health Care:Meta-Analysis in Context
    • (2nd edn). BMJ Books, Oxford
    • Egger, M., Davey-Smith, G. and Altman, D.G. (eds) (2001) Systematic Reviews in Health Care:Meta-Analysis in Context (2nd edn). BMJ Books, Oxford. [14]
    • (2001) , pp. 14
    • Egger, M.1    Davey-Smith, G.2    Altman, D.G.3
  • 56
    • 0037190575 scopus 로고    scopus 로고
    • Long term azithromycin in children with cystic fibrosis: a randomised, placebo-controlled crossover trial
    • Equi, A., Balfour-Lynn, I.M., Bush, A. and Rosenthal, M. (2002) Long term azithromycin in children with cystic fibrosis: a randomised, placebo-controlled crossover trial. Lancet, 360, 978-984. [12]
    • (2002) Lancet , vol.360 , pp. 978-984
    • Equi, A.1    Balfour-Lynn, I.M.2    Bush, A.3    Rosenthal, M.4
  • 57
    • 33746706779 scopus 로고    scopus 로고
    • The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial
    • and 9 others
    • Eron, J., Yeni, P., Gathe, J., Estrada, V., DeJesus, E., Staszewski, S., Lackey, P. and 9 others (2006) The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet, 368, 476-482. [11]
    • (2006) Lancet , vol.368 , pp. 476-482
    • Eron, J.1    Yeni, P.2    Gathe, J.3    Estrada, V.4    DeJesus, E.5    Staszewski, S.6    Lackey, P.7
  • 58
    • 84887193831 scopus 로고    scopus 로고
    • Guideline for Clinical Trials in Small Populations
    • European Medicines Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP)
    • European Medicines Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP) (2005) Guideline for Clinical Trials in Small Populations, www.emea.eu.int/pdfs/human/ewp/8356105en.pdf. [14]
    • (2005) , pp. 14
  • 59
    • 79956148471 scopus 로고    scopus 로고
    • Procedure for European Union Guidelines and Related Documents within the Pharmaceutical Legislative Framework
    • European Medicines Agency (EMEA), EMEA/P/24143/2004 Rev.1, EMEA, Canary Wharf, London
    • European Medicines Agency (EMEA). (2009) Procedure for European Union Guidelines and Related Documents within the Pharmaceutical Legislative Framework. EMEA/P/24143/2004 Rev.1, EMEA, Canary Wharf, London. [1]
    • (2009) , pp. 1
  • 60
  • 62
    • 52449106449 scopus 로고    scopus 로고
    • The baseline characteristics did not differ significantly
    • Fayers, P.M. and King, M. (2008) The baseline characteristics did not differ significantly. Quality of Life Research, 17, 1047-1048. [10]
    • (2008) Quality of Life Research , vol.17 , pp. 1047-1048
    • Fayers, P.M.1    King, M.2
  • 63
    • 84889360388 scopus 로고    scopus 로고
    • Quality of Life: Assessment, Analysis and Interpretation of Patients-reported Outcomes
    • 2nd edn, John Wiley & Sons, Ltd, Chichester
    • Fayers, P.M. and Machin, D. (2007) Quality of Life: Assessment, Analysis and Interpretation of Patients-reported Outcomes, 2nd edn, John Wiley & Sons, Ltd, Chichester. [14]
    • (2007) , pp. 14
    • Fayers, P.M.1    Machin, D.2
  • 64
    • 84887209575 scopus 로고    scopus 로고
    • Clinical Trial Design
    • ICR Publishing, Marlow
    • Fitzpatrick, S. (2008a) Clinical Trial Design, ICR Publishing, Marlow, www.icr-global.org. [1]
    • (2008) , pp. 1
    • Fitzpatrick, S.1
  • 65
    • 84887136397 scopus 로고    scopus 로고
    • The Clinical Trial Protocol
    • ICR Publishing, Marlow
    • Fitzpatrick, S. (2008b) The Clinical Trial Protocol, ICR Publishing, Marlow, www.icr-global.org. [1]
    • (2008) , pp. 1
    • Fitzpatrick, S.1
  • 66
    • 0003532215 scopus 로고
    • The Design and Analysis of Clinical Experiments
    • John Wiley & Sons Ltd, New York
    • Fleiss, J.L. (1986) The Design and Analysis of Clinical Experiments, John Wiley & Sons Ltd, New York. [13, 14]
    • (1986) , pp. 13-14
    • Fleiss, J.L.1
  • 67
    • 0004278273 scopus 로고
    • Guidelines for the Format and Content of the Clinical and Statistics Section of New Drug Applications
    • Food and Drug Administration (FDA), US Department of Health and Human Services, Public Health Service, Food and Drug Administration
    • Food and Drug Administration (FDA) (1988) Guidelines for the Format and Content of the Clinical and Statistics Section of New Drug Applications. US Department of Health and Human Services, Public Health Service, Food and Drug Administration. [1]
    • (1988) , pp. 1
  • 69
    • 67650651085 scopus 로고    scopus 로고
    • How to Display Data
    • BMJ Books, Oxford
    • Freeman, J.V., Walters, S.J. and Campbell, M.J. (2008) How to Display Data. BMJ Books, Oxford. [1, 8]
    • (2008) , pp. 1-8
    • Freeman, J.V.1    Walters, S.J.2    Campbell, M.J.3
  • 70
    • 0026445783 scopus 로고
    • Repeated measures in clinical trials: analysing mean summary statistics and its implications for design
    • Frison, L. and Pocock, S.J. (1992) Repeated measures in clinical trials: analysing mean summary statistics and its implications for design. Statistics in Medicine, 11, 1685-1704. [10]
    • (1992) Statistics in Medicine , vol.11 , pp. 1685-1704
    • Frison, L.1    Pocock, S.J.2
  • 71
    • 33644884271 scopus 로고    scopus 로고
    • Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement
    • Gagnier, J.J., Boon, H., Rochon, P., Moher, D., Barnes, J. and Bombardier, C. (2006) Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Annals of Internal Medicine, 144, 364-367. [10]
    • (2006) Annals of Internal Medicine , vol.144 , pp. 364-367
    • Gagnier, J.J.1    Boon, H.2    Rochon, P.3    Moher, D.4    Barnes, J.5    Bombardier, C.6
  • 72
    • 0346599430 scopus 로고    scopus 로고
    • Statistical checklists
    • In Statistics With Confidence, 2nd edn (eds D.G. Altman, D. Machin, T.N. Bryant and M.J. Gardner), London
    • Gardner, M.J., Machin, D., Campbell, M.J. and Altman, D.G. (2000) Statistical checklists. In Statistics With Confidence, 2nd edn (eds D.G. Altman, D. Machin, T.N. Bryant and M.J. Gardner), British Medical Journal, London, pp. 191-201. [10]
    • (2000) British Medical Journal
    • Gardner, M.J.1    Machin, D.2    Campbell, M.J.3    Altman, D.G.4
  • 73
    • 84887156216 scopus 로고    scopus 로고
    • The new EMEA-CHMP Guideline on Clinical Trials in Small Populations-Methodological and statistical considerations with published examples
    • Gerb, J. and Köpcke, W. (2007) The new EMEA-CHMP Guideline on Clinical Trials in Small Populations-Methodological and statistical considerations with published examples. Biocybernetics and Biomedical Engineering, 27, 59-66. [14]
    • (2007) Biocybernetics and Biomedical Engineering , vol.27 , pp. 59-66
    • Gerb, J.1    Köpcke, W.2
  • 78
    • 53249125873 scopus 로고    scopus 로고
    • National and multinational prospective trial registers
    • Grobler, L., Siegfried, N., Askie, L., Hooft, L., Tharyan, P. and Antes, G. (2008) National and multinational prospective trial registers. Lancet, 372, 1201-1202. [6]
    • (2008) Lancet , vol.372 , pp. 1201-1202
    • Grobler, L.1    Siegfried, N.2    Askie, L.3    Hooft, L.4    Tharyan, P.5    Antes, G.6
  • 79
    • 35748977092 scopus 로고    scopus 로고
    • Assessment of diclofenac or spinal manipulative therapy, or both, in addition to recommended first-line treatment for acute low back pain: a randomised controlled trial
    • Hancock, M.J., Maher, C.G., Latimer, J., McLachlan, A.J., Cooper, C.W., Day, R.O., Spindler, M.F. and McAuley, J.H. (2007) Assessment of diclofenac or spinal manipulative therapy, or both, in addition to recommended first-line treatment for acute low back pain: a randomised controlled trial. Lancet, 370, 1638-1643. [10, 13]
    • (2007) Lancet , vol.370 , pp. 1638-1643
    • Hancock, M.J.1    Maher, C.G.2    Latimer, J.3    McLachlan, A.J.4    Cooper, C.W.5    Day, R.O.6    Spindler, M.F.7    McAuley, J.H.8
  • 80
    • 53049101018 scopus 로고    scopus 로고
    • Paracetemol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial
    • doi: 10.1136/bmj.a1302
    • Hay, A.D., Costelloe, C., Redmond, N.M., Montgomery, A.A., Fletcher, M., Hollinghurst, S. and Peters, T.J. (2008) Paracetemol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial. BMJ, 337, a1302, doi: 10.1136/bmj.a1302. [2, 10]
    • (2008) BMJ , vol.337
    • Hay, A.D.1    Costelloe, C.2    Redmond, N.M.3    Montgomery, A.A.4    Fletcher, M.5    Hollinghurst, S.6    Peters, T.J.7
  • 81
    • 30944459841 scopus 로고    scopus 로고
    • Cochrane Handbook for Systematic Reviews of Interventions 4.2.4 [updated March 2005]
    • In The Cochrane Library, Issue 2, John Wiley & Sons, Ltd, Chichester
    • Higgins, J.P.T. and Green, S. (eds) (2005) Cochrane Handbook for Systematic Reviews of Interventions 4.2.4 [updated March 2005]. In The Cochrane Library, Issue 2, John Wiley & Sons, Ltd, Chichester. [1, 14]
    • (2005) , pp. 1-14
    • Higgins, J.P.T.1    Green, S.2
  • 82
    • 42549099895 scopus 로고    scopus 로고
    • CONSORT for reporting randomised trials in journal and conferences abstracts
    • Hopewell, S., Clarke, M., Moher, D., Wager, E., Middleton, P. and Altman, D.G. (2008) CONSORT for reporting randomised trials in journal and conferences abstracts. Lancet, 371, 281-283. [10]
    • (2008) Lancet , vol.371 , pp. 281-283
    • Hopewell, S.1    Clarke, M.2    Moher, D.3    Wager, E.4    Middleton, P.5    Altman, D.G.6
  • 84
    • 0032037709 scopus 로고    scopus 로고
    • Design and analysis issues in split mouth clinical trials
    • Hujoel, P.P. (1998) Design and analysis issues in split mouth clinical trials. Community Dentistry and Oral Epidemiology, 26, 85-86. [12]
    • (1998) Community Dentistry and Oral Epidemiology , vol.26 , pp. 85-86
    • Hujoel, P.P.1
  • 85
    • 0024115469 scopus 로고
    • Evaluation of test statistics in split mouth clinical trials
    • Hujoel, P.P. and Moulton, L.H. (1988) Evaluation of test statistics in split mouth clinical trials. Journal of Periodontal Research, 23, 378-386. [12]
    • (1988) Journal of Periodontal Research , vol.23 , pp. 378-386
    • Hujoel, P.P.1    Moulton, L.H.2
  • 86
    • 42149139845 scopus 로고
    • Clinical safety data management: definitions and standards for expedited reporting
    • ICH E2A, CPMP/ICH/377/95, EMEA, Canary Wharf, London
    • ICH E2A (1994) Clinical safety data management: definitions and standards for expedited reporting. CPMP/ICH/377/95, EMEA, Canary Wharf, London, www.emea.eu.int. [6]
    • (1994) , pp. 6
  • 87
    • 84872155457 scopus 로고    scopus 로고
    • Note for guidance on clinical safety data management: data elements for transmission of individual case safety reports
    • ICH E2B(M), CPMP/ICH/287/95, EMEA, Canary Wharf, London
    • ICH E2B(M) (2000) Note for guidance on clinical safety data management: data elements for transmission of individual case safety reports. CPMP/ICH/287/95, EMEA, Canary Wharf, London, www.emea.eu.int. [6]
    • (2000) , pp. 6
  • 88
    • 7244238543 scopus 로고
    • Structure and content of clinical study reports
    • ICH E3, CPMP/ICH/137/95, EMEA, Canary Wharf, London
    • ICH E3 (1995) Structure and content of clinical study reports. CPMP/ICH/137/95, EMEA, Canary Wharf, London, www.emea.eu.int. [6, 10]
    • (1995) , pp. 6-10
  • 89
    • 0003663972 scopus 로고    scopus 로고
    • Guideline for good clinical practice
    • ICH E6 (R1), CPMP/ICH/135/95, EMEA, Canary Wharf, London
    • ICH E6 (R1) (1996) Guideline for good clinical practice. CPMP/ICH/135/95, EMEA, Canary Wharf, London, www.emea.eu.int. [1, 3, 4, 5, 6]
    • (1996) , pp. 1-6
  • 90
    • 0008432098 scopus 로고    scopus 로고
    • General considerations for clinical trials
    • ICH E8, CPMP/ICH/291/95, EMEA, Canary Wharf, London
    • ICH E8 (1997) General considerations for clinical trials. CPMP/ICH/291/95, EMEA, Canary Wharf, London, www.emea.eu.int. [6]
    • (1997) , pp. 6
  • 91
    • 0003875319 scopus 로고    scopus 로고
    • Statistical principles for clinical trials
    • ICH E9, CPMP/ICH/363/96, EMEA, Canary Wharf, London
    • ICH E9 (1998) Statistical principles for clinical trials. CPMP/ICH/363/96, EMEA, Canary Wharf, London, www.emea.eu.int. [1, 4, 5, 6]
    • (1998) , pp. 1-6
  • 92
    • 0033566769 scopus 로고    scopus 로고
    • Statistical principles for clinical trials: ICH Harmonised Tripartite Guideline
    • ICH E9 Expert Working Group
    • ICH E9 Expert Working Group (1999) Statistical principles for clinical trials: ICH Harmonised Tripartite Guideline, Statistics in Medicine, 18, 1905-1942. [1, 2, 4, 5, 6, 9]
    • (1999) Statistics in Medicine , vol.18
  • 93
    • 0344005734 scopus 로고    scopus 로고
    • Choice of control group in clinical trials
    • ICH E10, CPMP/ICH/2711/99, EMEA, Canary Wharf, London
    • ICH E10 (2000) Choice of control group in clinical trials. CPMP/ICH/2711/99, EMEA, Canary Wharf, London, www.emea.eu.int. [2, 6]
    • (2000) , pp. 2-6
  • 94
    • 84887147040 scopus 로고    scopus 로고
    • The Fundamental Guidelines for Clinical Research V2.0
    • Institute of Clinical Research, ICR Publishing
    • Institute of Clinical Research (2008) The Fundamental Guidelines for Clinical Research V2.0, ICR Publishing. [1, 2, 3]
    • (2008) , pp. 1-3
  • 96
    • 2942756927 scopus 로고    scopus 로고
    • Randomised Controlled Trials
    • London
    • Jadad, A. (1998) Randomised Controlled Trials, British Medical Journal, London. [1]
    • (1998) British Medical Journal , pp. 1
    • Jadad, A.1
  • 98
    • 48149113969 scopus 로고    scopus 로고
    • Fuel metabolism during exercise in euglycaemia and hyperglycaemia in patients with type 1 diabetes mellitus-a prospective single-blind randomised crossover trial
    • Jenni, S., Oetliker, C., Allemann, S., Ith, M., Tappy, L., Wuerth, S., Egger, A., Boesch, C., Schneiter, Ph., Diem, P., Christ, E. and Stettler, C. (2008) Fuel metabolism during exercise in euglycaemia and hyperglycaemia in patients with type 1 diabetes mellitus-a prospective single-blind randomised crossover trial. Diabetologia, 51, 1457-1465. [12]
    • (2008) Diabetologia , vol.51 , pp. 1457-1465
    • Jenni, S.1    Oetliker, C.2    Allemann, S.3    Ith, M.4    Tappy, L.5    Wuerth, S.6    Egger, A.7    Boesch, C.8    Schneiter, P.9    Diem, P.10    Christ, E.11    Stettler, C.12
  • 99
    • 4344564186 scopus 로고    scopus 로고
    • Validation of a questionnaire for self-assessment of sexual function and vaginal changes after gynaecological cancer
    • Jensen, P.T., Klee, M.C., Thranov, I. and Groenvold, M. (2004) Validation of a questionnaire for self-assessment of sexual function and vaginal changes after gynaecological cancer. Psycho-Oncology, 13, 577-592. [4]
    • (2004) Psycho-Oncology , vol.13 , pp. 577-592
    • Jensen, P.T.1    Klee, M.C.2    Thranov, I.3    Groenvold, M.4
  • 100
    • 50849109200 scopus 로고    scopus 로고
    • The cross-over trial: a subtle knife
    • Jones, B. (2008) The cross-over trial: a subtle knife. Significance, 5, 135-137. [12]
    • (2008) Significance , vol.5 , pp. 135-137
    • Jones, B.1
  • 101
    • 0029987569 scopus 로고    scopus 로고
    • Trials to assess equivalence: the importance of rigorous methods
    • Jones, B., Jarvis, P., Lewis, J.A. and Ebbutt, A.F. (1996) Trials to assess equivalence: the importance of rigorous methods. British Medical Journal, 313, 36-39. [11]
    • (1996) British Medical Journal , vol.313 , pp. 36-39
    • Jones, B.1    Jarvis, P.2    Lewis, J.A.3    Ebbutt, A.F.4
  • 102
    • 18344382517 scopus 로고    scopus 로고
    • Lack of concealment may lead to selection bias in cluster randomized trials of palliative care
    • Jordhøy, M.S., Fayers, P.M.,Ahlner-Elmqvist, M. and Kaasa S. (2002) Lack of concealment may lead to selection bias in cluster randomized trials of palliative care. Palliative Medicine, 16, 43-49. [11]
    • (2002) Palliative Medicine , vol.16 , pp. 43-49
    • Jordhøy, M.S.1    Fayers, P.M.2    Ahlner-Elmqvist, M.3    Kaasa, S.4
  • 103
    • 0035822324 scopus 로고    scopus 로고
    • Assessing the quality of controlled clinical trials
    • Jüni, P., Altman, D.G. and Egger, M. (2001). Assessing the quality of controlled clinical trials. BMJ, 323, 42-46. [14]
    • (2001) BMJ , vol.323
    • Jüni, P.1    Altman, D.G.2    Egger, M.3
  • 104
    • 40949142200 scopus 로고    scopus 로고
    • Effectiveness of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: an open randomised clinical trial
    • and 13 others
    • Kahn, R.S., Fleischhacker, W.W., Boter, H., Davidson, M., Vergouwe, Y., Keet, I.P.M. and 13 others (2008) Effectiveness of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: an open randomised clinical trial. Lancet, 371, 1085-1097. [2, 10, 13]
    • (2008) Lancet , vol.371 , pp. 1085-1097
    • Kahn, R.S.1    Fleischhacker, W.W.2    Boter, H.3    Davidson, M.4    Vergouwe, Y.5    Keet, I.P.M.6
  • 106
    • 0033760043 scopus 로고    scopus 로고
    • A randomized trial of 13-cis retinoic acid in children with advanced neuroblastoma after high-dose therapy
    • Kohler, J.A., Imeson, J., Ellershaw, C. and Lie, S.O. (2000) A randomized trial of 13-cis retinoic acid in children with advanced neuroblastoma after high-dose therapy. British Journal of Cancer, 83, 1124-1127. [8]
    • (2000) British Journal of Cancer , vol.83 , pp. 1124-1127
    • Kohler, J.A.1    Imeson, J.2    Ellershaw, C.3    Lie, S.O.4
  • 107
    • 36549078679 scopus 로고    scopus 로고
    • Effect of the cholesteryl ester transfer protein inhibitor, anacetrapib, on lipoproteins in patients with dyslipidaemia and on 24-h ambulatory blood pressure in healthy individuals: two double-blind, randomized placebocontrolled phase I studies
    • Krishna, R., Anderson, M.S., Bergman, A.J., Jin, B., Fallon, M., Cote, J., Rosko, K., Chavez-Eng, C., Lutz, R., Bloomfield, D.M., Gutierrez, M., Doherty, J., Bieberdorf, F., Chodakewitz, J., Gottesdiener, K.M. and Wagner, J.A. (2007) Effect of the cholesteryl ester transfer protein inhibitor, anacetrapib, on lipoproteins in patients with dyslipidaemia and on 24-h ambulatory blood pressure in healthy individuals: two double-blind, randomized placebocontrolled phase I studies. Lancet, 370, 1907-1914. [1, 2, 10, 12]
    • (2007) Lancet , vol.370 , pp. 1907-1914
    • Krishna, R.1    Anderson, M.S.2    Bergman, A.J.3    Jin, B.4    Fallon, M.5    Cote, J.6    Rosko, K.7    Chavez-Eng, C.8    Lutz, R.9    Bloomfield, D.M.10    Gutierrez, M.11    Doherty, J.12    Bieberdorf, F.13    Chodakewitz, J.14    Gottesdiener, K.M.15    Wagner, J.A.16
  • 108
    • 0036909370 scopus 로고    scopus 로고
    • Does pre-and postoperative metronidazole treatment lower vaginal cuff infection rate after abdominal hysterectomy among women with bacterial vaginosis?
    • Larsson, P.-G. and Carlsson, B. (2002) Does pre-and postoperative metronidazole treatment lower vaginal cuff infection rate after abdominal hysterectomy among women with bacterial vaginosis? Infectious Diseases in Obstetrics and Gynecolgy, 10, 133-140. [10, 14]
    • (2002) Infectious Diseases in Obstetrics and Gynecolgy , vol.10
    • Larsson, P.-G.1    Carlsson, B.2
  • 109
    • 37549046808 scopus 로고    scopus 로고
    • Adjuvant intra-arterial iodine-131-labelled lipiodol for resectable hepatocellular carcinoma: a prospective randomized trialupdate on 5-year and 10-year survival
    • Lau, W.Y., Lai, E.C.H., Leung, T.W.T. and Yu, S.C.H. (2008) Adjuvant intra-arterial iodine-131-labelled lipiodol for resectable hepatocellular carcinoma: a prospective randomized trialupdate on 5-year and 10-year survival. Annals of Surgery, 247, 43-48. [7]
    • (2008) Annals of Surgery , vol.247 , pp. 43-48
    • Lau, W.Y.1    Lai, E.C.H.2    Leung, T.W.T.3    Yu, S.C.H.4
  • 111
    • 0003726271 scopus 로고    scopus 로고
    • Java Applets for Power and Sample Size
    • Lenth, R.V. (2006) Java Applets for Power and Sample Size. www.stat.uiowa.edu/~rlenth/Power. [9]
    • (2006) , pp. 9
    • Lenth, R.V.1
  • 112
    • 0036040229 scopus 로고    scopus 로고
    • A 2-dose regimen of recombinant hepatitis B vaccine with the immune stimulant AS04 compared with the standard 3-dose regimen of EnderixTM-B in healthy young adults
    • Levie, K., Gjorup, I., Skinhøj, P. and Stoffel, M. (2002) A 2-dose regimen of recombinant hepatitis B vaccine with the immune stimulant AS04 compared with the standard 3-dose regimen of EnderixTM-B in healthy young adults. Scandinavian Journal of Infectious Disease, 34, 610-614. [1]
    • (2002) Scandinavian Journal of Infectious Disease , vol.34 , pp. 610-614
    • Levie, K.1    Gjorup, I.2    Skinhøj, P.3    Stoffel, M.4
  • 113
    • 34547697475 scopus 로고    scopus 로고
    • Efficacy of sepropterin dihydrochloride (tetrahydrobiopterin, 6R-BH4) for reduction of phenylalanine concentration in patients with phenylketonuria: a phase III randomised placebo-controlled study
    • Levy,H.L., Milanowski, A., Chakrapani,M., Cleary,M., Lee, P., Trefz, FK.,Whitley,C.B., Feillet, F., Feigenbaum, A.S., Bebchuk, J.D., Christ-Schmidt, H. and Dorenbaum, A. (2007) Efficacy of sepropterin dihydrochloride (tetrahydrobiopterin, 6R-BH4) for reduction of phenylalanine concentration in patients with phenylketonuria: a phase III randomised placebo-controlled study. Lancet, 370, 504-510. [11]
    • (2007) Lancet , vol.370 , pp. 504-510
    • Levy, H.L.1    Milanowski, A.2    Chakrapani, M.3    Cleary, M.4    Lee, P.5    Trefz, F.K.6    Whitley, C.B.7    Feillet, F.8    Feigenbaum, A.S.9    Bebchuk, J.D.10    Christ-Schmidt, H.11    Dorenbaum, A.12
  • 114
    • 0037129704 scopus 로고    scopus 로고
    • Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial
    • Llovet, J.M., Real, M.I., Montaňa, X., Planas, R., Coll, S., Aponte, J., Ayuso, C., Sala, M., Muchart, J., Solà , R., Rodés, J. and Bruix, J. (2002) Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet, 359, 1734-1739. [14]
    • (2002) Lancet , vol.359 , pp. 1734-1739
    • Llovet, J.M.1    Real, M.I.2    Montaňa, X.3    Planas, R.4    Coll, S.5    Aponte, J.6    Ayuso, C.7    Sala, M.8    Muchart, J.9    Solà, R.10    Rodés, J.11    Bruix, J.12
  • 115
    • 0035522973 scopus 로고    scopus 로고
    • Clinical investigation of two glass-ionomer restoratives used with the atraumatic restorative treatment approach in china: two-years results
    • Lo, E.C.M., Luo, Y., Fan, M.W. and Wei, S.H.Y. (2001) Clinical investigation of two glass-ionomer restoratives used with the atraumatic restorative treatment approach in china: two-years results. Caries Research, 35, 458-463. [1, 5, 10, 12]
    • (2001) Caries Research , vol.35 , pp. 458-463
    • Lo, E.C.M.1    Luo, Y.2    Fan, M.W.3    Wei, S.H.Y.4
  • 117
    • 0037172426 scopus 로고    scopus 로고
    • Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: a randomised controlled trial
    • Lobo, D.N., Bostock, K.A., Neal, K.R., Perkins, A.C., Rowlands, B.J. and Allison, S.P. (2002) Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: a randomised controlled trial. Lancet, 359, 1812-1818. [1, 9]
    • (2002) Lancet , vol.359 , pp. 1812-1818
    • Lobo, D.N.1    Bostock, K.A.2    Neal, K.R.3    Perkins, A.C.4    Rowlands, B.J.5    Allison, S.P.6
  • 118
    • 84889283743 scopus 로고    scopus 로고
    • Sample Sizes Tables for Clinical Studies
    • 3rd edn, Wiley-Blackwell, Oxford
    • Machin, D., Campbell, M.J., Tan, S.B. and Tan, S.H. (2009) Sample Sizes Tables for Clinical Studies, 3rd edn, Wiley-Blackwell, Oxford. [1, 3, 9, 10, 12]
    • (2009) , pp. 1-12
    • Machin, D.1    Campbell, M.J.2    Tan, S.B.3    Tan, S.H.4
  • 119
    • 84889402962 scopus 로고    scopus 로고
    • Survival Analysis: a Practical Approach
    • 2nd edn, John Wiley & Sons, Ltd, Chichester
    • Machin, D., Cheung, Y.B. and Parmar, M.K.B. (2006) Survival Analysis: a Practical Approach, 2nd edn, John Wiley & Sons, Ltd, Chichester. [8]
    • (2006) , pp. 8
    • Machin, D.1    Cheung, Y.B.2    Parmar, M.K.B.3
  • 120
    • 84890638266 scopus 로고    scopus 로고
    • Textbook of Clinical Trials
    • 2nd edn, John Wiley & Sons, Ltd, Chichester
    • Machin, D., Day, S. and Green, S. (eds) (2006) Textbook of Clinical Trials, 2nd edn, John Wiley & Sons, Ltd, Chichester. [1]
    • (2006) , pp. 1
    • Machin, D.1    Day, S.2    Green, S.3
  • 121
    • 0034104696 scopus 로고    scopus 로고
    • The ethics of randomization trials in the context of cleft palate research
    • Machin, D. and Lee, S.T. (2000) The ethics of randomization trials in the context of cleft palate research. Plastic and Reconstructive Surgery, 105, 1566-1568. [14]
    • (2000) Plastic and Reconstructive Surgery , vol.105 , pp. 1566-1568
    • Machin, D.1    Lee, S.T.2
  • 123
    • 0041408235 scopus 로고    scopus 로고
    • Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function taking angiotensin-converting-enzyme inhibitors: the CHARM-Added trial
    • McMurray, J.J.V.,ö stergren, J., Swedberg, K. Granger, C.B., Held, P., Mivhelson, E.L., Olofsson, B., Yusuf, S., Pfeffer, M.A. (2003) Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function taking angiotensin-converting-enzyme inhibitors: the CHARM-Added trial. Lancet, 362, 767-771. [14]
    • (2003) Lancet , vol.362 , pp. 767-771
    • McMurray, J.J.V.1    Ö Stergren, J.2    Swedberg, K.3    Granger, C.B.4    Held, P.5    Mivhelson, E.L.6    Olofsson, B.7    Yusuf, S.8    Pfeffer, M.A.9
  • 124
    • 1442345733 scopus 로고    scopus 로고
    • Cluster Randomised Trials: Methodological and Ethical Considerations
    • Medical Research Council, MRC Clinical Trials Series, Medical Research Council, London
    • Medical Research Council (2002) Cluster Randomised Trials: Methodological and Ethical Considerations, MRC Clinical Trials Series, Medical Research Council, London. [11]
    • (2002) , pp. 11
  • 125
    • 0010622331 scopus 로고    scopus 로고
    • Randomized trial of palliative two-fraction versus more intensive 13-fraction radiotherapy for patients with inoperable non-small cell lung cancer and good performance status
    • Medical Research Council Lung Cancer Working Party
    • Medical Research Council Lung Cancer Working Party (1996) Randomized trial of palliative two-fraction versus more intensive 13-fraction radiotherapy for patients with inoperable non-small cell lung cancer and good performance status. Clinical Oncology, 8, 167-175. [2]
    • (1996) Clinical Oncology , vol.8 , pp. 167-175
  • 126
    • 84965185073 scopus 로고
    • The prevention of whooping-cough by vaccination
    • Medical Research Council Whooping-Cough Immunization Committee
    • Medical Research Council Whooping-Cough Immunization Committee (1951) The prevention of whooping-cough by vaccination. British Medical Journal, 1, 1463-1471. [1]
    • (1951) British Medical Journal , vol.1 , pp. 1463-1471
  • 127
    • 33644837550 scopus 로고    scopus 로고
    • Azathioprine dosed by thiopurine methyltransferase activity for moderate-to-severe atopic eczema: a double-blind, randomised controlled trial
    • Meggitt, S.J., Gray, J.C. and Reynolds, N.J. (2006) Azathioprine dosed by thiopurine methyltransferase activity for moderate-to-severe atopic eczema: a double-blind, randomised controlled trial. Lancet, 367, 839-846. [1, 2, 4, 8, 9, 10, 11, 12]
    • (2006) Lancet , vol.367 , pp. 839-846
    • Meggitt, S.J.1    Gray, J.C.2    Reynolds, N.J.3
  • 128
    • 0037431733 scopus 로고    scopus 로고
    • Effect on hip fractures of increased use of hip protectors in nursing homes: cluster randomised controlled trial
    • Meyer,G.,Warnke,A., Mülhauser, I. and Bender, R. (2003) Effect on hip fractures of increased use of hip protectors in nursing homes: cluster randomised controlled trial. BMJ, 326, 76-78. [1, 2, 11]
    • (2003) BMJ , vol.326 , pp. 76-78
    • Meyer, G.1    Warnke, A.2    Mülhauser, I.3    Bender, R.4
  • 130
    • 0033610734 scopus 로고    scopus 로고
    • Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement
    • Moher, D., Cook, D.J., Eastwood, S., Olkin, I., Rennie, D., and Stroup, D.F. (1999) Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Lancet, 354, 1896-1900. [14]
    • (1999) Lancet , vol.354 , pp. 1896-1900
    • Moher, D.1    Cook, D.J.2    Eastwood, S.3    Olkin, I.4    Rennie, D.5    Stroup, D.F.6
  • 131
    • 0035857966 scopus 로고    scopus 로고
    • The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials
    • for the CONSORT Group
    • Moher, D., Schultz, K.F. and Altman, D.G., for the CONSORT Group (2001) The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet, 357, 1191-1194. [1, 2, 5, 10]
    • (2001) Lancet , vol.357 , pp. 1191-1194
    • Moher, D.1    Schultz, K.F.2    Altman, D.G.3
  • 133
    • 43449092540 scopus 로고    scopus 로고
    • Active symptom control with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma (MS01): a multicentre trial
    • and 8 others
    • Muers, M.F., Stephens, R.J., Fisher, P., Darlison, L., Higgs, C.M.B., Lowry, L., Nicholson, A.G., O'Brien, M. and 8 others (2008) Active symptom control with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma (MS01): a multicentre trial. Lancet, 371, 1685-1694. [13]
    • (2008) Lancet , vol.371 , pp. 1685-1694
    • Muers, M.F.1    Stephens, R.J.2    Fisher, P.3    Darlison, L.4    Higgs, C.M.B.5    Lowry, L.6    Nicholson, A.G.7    O'Brien, M.8
  • 134
    • 12344312699 scopus 로고    scopus 로고
    • Common Terminology Criteria for Adverse Events
    • National Cancer Institute, (v3.0 CTCAE), National Cancer Institute, Bethesda
    • National Cancer Institute (2003) Common Terminology Criteria for Adverse Events. (v3.0 CTCAE), National Cancer Institute, Bethesda, www.ctep.cancer.gov/reporting/ctc.html. [3]
    • (2003) , pp. 3
  • 135
    • 84887165236 scopus 로고    scopus 로고
    • Power analysis and sample size software (PASS): Version 2005
    • National Council for Social Studies, Kaysville, UT
    • National Council for Social Studies (2005) Power analysis and sample size software (PASS): Version 2005, Kaysville, UT. [9]
    • (2005) , pp. 9
  • 136
    • 0003079992 scopus 로고    scopus 로고
    • Proportions and their differences
    • In Statistics with Confidence, 2nd edn (eds D.G. Altman, D. Machin, T.N. Bryant and M.J. Gardner), London
    • Newcombe, R.G. and Altman, D.G. (2000) Proportions and their differences. In Statistics with Confidence, 2nd edn (eds D.G. Altman, D. Machin, T.N. Bryant and M.J. Gardner), British Medical Journal Books, London, pp. 45-56. [8]
    • (2000) British Medical Journal Books
    • Newcombe, R.G.1    Altman, D.G.2
  • 137
    • 0032129953 scopus 로고    scopus 로고
    • A sequential randomised controlled trial comparing a dry visco-elastic polymer gel pad and standard operating table mattresses in the prevention of post-operative pressure sores
    • Nixon, J., McElvenny D., Mason, S., Brown, J. and Bond, S. (1998) A sequential randomised controlled trial comparing a dry visco-elastic polymer gel pad and standard operating table mattresses in the prevention of post-operative pressure sores. International Journal of Nursing Studies, 35, 193-203. [10, 14]
    • (1998) International Journal of Nursing Studies , vol.35 , pp. 193-203
    • Nixon, J.1    McElvenny, D.2    Mason, S.3    Brown, J.4    Bond, S.5
  • 138
    • 34250332517 scopus 로고    scopus 로고
    • Modified overt aggression scale (MOAS) for people with intellectual disability and aggressive challenging behaviour: a reliability study
    • Oliver, P.C., Crawford, M.J., Rao, B., Reece, B. and Tyrer, P. (2007) Modified overt aggression scale (MOAS) for people with intellectual disability and aggressive challenging behaviour: a reliability study. Journal of Applied Research in Intellectual Disability, 20, 368-272. [10]
    • (2007) Journal of Applied Research in Intellectual Disability , vol.20 , pp. 368-272
    • Oliver, P.C.1    Crawford, M.J.2    Rao, B.3    Reece, B.4    Tyrer, P.5
  • 140
    • 42049103402 scopus 로고    scopus 로고
    • Efficacy of ISA247 in plaque psoriasis: a randomised multicentre, double-blind, placebo-controlled phase III study
    • Papp, K., Bissonnette, R., Rosoph, L., Wasel, N., Lynde, C.W., Searles, G., Shear, N.H., Huizinga, R.B. and Maksymowych, W.P. (2008) Efficacy of ISA247 in plaque psoriasis: a randomised multicentre, double-blind, placebo-controlled phase III study. Lancet, 371, 1337-1342. [13]
    • (2008) Lancet , vol.371 , pp. 1337-1342
    • Papp, K.1    Bissonnette, R.2    Rosoph, L.3    Wasel, N.4    Lynde, C.W.5    Searles, G.6    Shear, N.H.7    Huizinga, R.B.8    Maksymowych, W.P.9
  • 142
    • 84887197748 scopus 로고    scopus 로고
    • Operating Manual 4.4, MPS Research Unit
    • PEST, University of Reading, Reading
    • PEST (2004) Operating Manual 4.4, MPS Research Unit, University of Reading, Reading. [14]
    • (2004) , pp. 14
  • 146
    • 33745776490 scopus 로고    scopus 로고
    • Flexibility by design
    • GCPj, Informa UK Ltd, July
    • Phillips, A. (2006) Flexibility by design, GCPj, Informa UK Ltd, July, pp. 13-17, www.GCPj.com [14]
    • (2006)
    • Phillips, A.1
  • 149
    • 0035892614 scopus 로고    scopus 로고
    • Use of the equivalence approach in reproductive health clinical trials
    • Piaggio, G. and Pinol, A.P. (2001) Use of the equivalence approach in reproductive health clinical trials. Statistics in Medicine, 20, 3571-3577. [11]
    • (2001) Statistics in Medicine , vol.20 , pp. 3571-3577
    • Piaggio, G.1    Pinol, A.P.2
  • 150
    • 0003576014 scopus 로고
    • Clinical Trials: a Practical Approach
    • John Wiley & Sons, Ltd, Chichester
    • Pocock, S.J. (1983) Clinical Trials: a Practical Approach, John Wiley & Sons, Ltd, Chichester. [1, 8]
    • (1983) , pp. 1-8
    • Pocock, S.J.1
  • 151
    • 66149190550 scopus 로고    scopus 로고
    • Translating statistical findings into plain English
    • Pocock, S.J. and Ware, J.E. (2009) Translating statistical findings into plain English. Lancet, 373, 1926-1928. [10]
    • (2009) Lancet , vol.373 , pp. 1926-1928
    • Pocock, S.J.1    Ware, J.E.2
  • 152
    • 0033586193 scopus 로고    scopus 로고
    • Trials stopped early: too good to be true?
    • Pocock, S.J. and White, I. (1999) Trials stopped early: too good to be true? Lancet, 353, 943-944. [7]
    • (1999) Lancet , vol.353
    • Pocock, S.J.1    White, I.2
  • 154
    • 51149092388 scopus 로고    scopus 로고
    • Twenty-four-hour intraocular pressure and blood pressure levels with bimatoprost versus latanoprost in patients with normal-tension glaucoma
    • Quaranta, L., Pizzolante, T., Riva, I., Haidich, A.-B., Konstas, G.P. and Stewart, W.C. (2008) Twenty-four-hour intraocular pressure and blood pressure levels with bimatoprost versus latanoprost in patients with normal-tension glaucoma. British Journal of Ophthalmology, 92, 1227-1231. [12]
    • (2008) British Journal of Ophthalmology , vol.92 , pp. 1227-1231
    • Quaranta, L.1    Pizzolante, T.2    Riva, I.3    Haidich, A.-B.4    Konstas, G.P.5    Stewart, W.C.6
  • 155
    • 0012358466 scopus 로고    scopus 로고
    • Biostatistics in Clinical Trials
    • John Wiley & Sons, Ltd, Chichester
    • Redwood, C. and Colton, T. (eds) (2001) Biostatistics in Clinical Trials, John Wiley & Sons, Ltd, Chichester. [1]
    • (2001) , pp. 1
    • Redwood, C.1    Colton, T.2
  • 157
    • 84887160030 scopus 로고    scopus 로고
    • Getting Started with the SAS Power and Sample Size Application: Version 9.1
    • SAS Institute, SAS Institute, Cary, NC
    • SAS Institute (2004) Getting Started with the SAS Power and Sample Size Application: Version 9.1, SAS Institute, Cary, NC. [9]
    • (2004) , pp. 9
  • 158
    • 77956888457 scopus 로고
    • Partial residuals for the proportional hazards regression model
    • Schoenfeld, D. (1982) Partial residuals for the proportional hazards regression model. Biometrika, 69, 239-241. [10]
    • (1982) Biometrika , vol.69 , pp. 239-241
    • Schoenfeld, D.1
  • 160
    • 45849084312 scopus 로고    scopus 로고
    • Maintenance treatment with buprenorphine and naltrexone for heroin dependence in Malaysia: a randomised, doubleblind, placebo controlled trial
    • Schottenfeld, R.S., Charwarski, M.C. and Mazlan, M. (2008) Maintenance treatment with buprenorphine and naltrexone for heroin dependence in Malaysia: a randomised, doubleblind, placebo controlled trial. Lancet, 371, 2192-2200. [13]
    • (2008) Lancet , vol.371 , pp. 2192-2200
    • Schottenfeld, R.S.1    Charwarski, M.C.2    Mazlan, M.3
  • 161
    • 0003678816 scopus 로고    scopus 로고
    • Cross-Over Trials in Clinical Research
    • 2nd edn, John Wiley & Sons, Ltd, Chichester
    • Senn, S.J. (2002) Cross-Over Trials in Clinical Research, 2nd edn, John Wiley & Sons, Ltd, Chichester. [12]
    • (2002) , pp. 12
    • Senn, S.J.1
  • 162
    • 84948079859 scopus 로고    scopus 로고
    • Statistical Issues in Drug Development
    • 2nd edn, John Wiley & Sons, Ltd, Chichester
    • Senn, S. (2007) Statistical Issues in Drug Development, 2nd edn, John Wiley & Sons, Ltd, Chichester. [1]
    • (2007) , pp. 1
    • Senn, S.1
  • 163
    • 4544226824 scopus 로고    scopus 로고
    • A randomized controlled trial to compare calcipotriol with betamethasone valerate for the treatment of cutaneous lichen planus
    • Singapore Lichen Planus Study Group
    • Singapore Lichen Planus Study Group (2004) A randomized controlled trial to compare calcipotriol with betamethasone valerate for the treatment of cutaneous lichen planus. Journal of Dermatological Treatment, 15, 141-145. [10]
    • (2004) Journal of Dermatological Treatment , vol.15 , pp. 141-145
  • 165
    • 40749114497 scopus 로고    scopus 로고
    • Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (Option study): a double-blind, placebocontrolled, randomised trial
    • Smolen, J.S., Beaulieu, A., Rubbert-Roth, A., Ramos-Remus, C., Rovensky, J., Alecock, E., Woodworth, T., and Alten, R. (2008) Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (Option study): a double-blind, placebocontrolled, randomised trial. Lancet, 371, 987-997. [10, 13]
    • (2008) Lancet , vol.371 , pp. 987-997
    • Smolen, J.S.1    Beaulieu, A.2    Rubbert-Roth, A.3    Ramos-Remus, C.4    Rovensky, J.5    Alecock, E.6    Woodworth, T.7    Alten, R.8
  • 167
    • 0003392284 scopus 로고    scopus 로고
    • EORTC Quality of Life Study Group: Guidelines for Developing Questionnaire Modules
    • EORTC, Brussels
    • Sprangers, M.A., Cull, A. and Groenvold, M. (1998) EORTC Quality of Life Study Group: Guidelines for Developing Questionnaire Modules, EORTC, Brussels. [2, 4]
    • (1998) , pp. 2-4
    • Sprangers, M.A.1    Cull, A.2    Groenvold, M.3
  • 168
    • 31644450063 scopus 로고    scopus 로고
    • Stata Statistical Software: Release 10
    • StataCorp, Stata Press, College Station, Texas
    • StataCorp (2007) Stata Statistical Software: Release 10, Stata Press, College Station, Texas. [8, 9, 10]
    • (2007) , pp. 8-10
  • 169
    • 84887165458 scopus 로고    scopus 로고
    • NQuery Advise: Version 6.0
    • Statistical Solutions, Saugus, MA
    • Statistical Solutions (2006) NQuery Advise: Version 6.0, Saugus, MA. [9]
    • (2006) , pp. 9
  • 170
  • 171
    • 52049108262 scopus 로고    scopus 로고
    • Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial
    • and 10 others
    • Szefler, S.S., Mitchell, H., Sorkness, C.A., Gergen, P.J., O'Connor, G.T., Morgan, W.J., Kattan, M. and 10 others (2008) Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial. Lancet, 372, 1065-1072. [10]
    • (2008) Lancet , vol.372 , pp. 1065-1072
    • Szefler, S.S.1    Mitchell, H.2    Sorkness, C.A.3    Gergen, P.J.4    O'Connor, G.T.5    Morgan, W.J.6    Kattan, M.7
  • 172
    • 0037385232 scopus 로고    scopus 로고
    • Elicitation of prior distributions for a phase III randomized controlled trial of adjuvant therapy with surgery for hepatocellular carcinoma
    • Tan, S.B., Chung, Y.F.A., Tai, B.C., Cheung, Y.B. and Machin, D. (2003) Elicitation of prior distributions for a phase III randomized controlled trial of adjuvant therapy with surgery for hepatocellular carcinoma. Controlled Clinical Trials, 24, 110-121. [14]
    • (2003) Controlled Clinical Trials , vol.24 , pp. 110-121
    • Tan, S.B.1    Chung, Y.F.A.2    Tai, B.C.3    Cheung, Y.B.4    Machin, D.5
  • 173
  • 174
    • 39149121831 scopus 로고    scopus 로고
    • Can external and subjective information ever be used to reduce the size of a randomised controlled trial?
    • Tan, S.B., Wee, J., Wong, H.B. and Machin, D. (2008) Can external and subjective information ever be used to reduce the size of a randomised controlled trial? Contemporary Clinical Trials, 29, 211-219. [14]
    • (2008) Contemporary Clinical Trials , vol.29
    • Tan, S.B.1    Wee, J.2    Wong, H.B.3    Machin, D.4
  • 175
    • 0034846874 scopus 로고    scopus 로고
    • Randomized clinical trial of the effect of open versus laparoscopically assisted colectomy on systemic immunity in patients with colorectal cancer
    • Tang, C.-L., Eu, K.-W., Tai, B.-C., Soh, J.G.S., Machin, D. and Seow-Choen, F. (2001) Randomized clinical trial of the effect of open versus laparoscopically assisted colectomy on systemic immunity in patients with colorectal cancer. British Journal of Surgery, 88, 801-807. [4]
    • (2001) British Journal of Surgery , vol.88 , pp. 801-807
    • Tang, C.-L.1    Eu, K.-W.2    Tai, B.-C.3    Soh, J.G.S.4    Machin, D.5    Seow-Choen, F.6
  • 177
    • 0032901932 scopus 로고    scopus 로고
    • Methods for evaluating area-wide and organisation-based interventions in health and health care: a systematic review
    • Ukoumunne, O.C., Gulliford, M.C., Chinn, S., Sterne, J.A.C., Burney, P.G.J. (1999) Methods for evaluating area-wide and organisation-based interventions in health and health care: a systematic review. Health Technology Assessment, 3(5), www.hta.ac.uk/fullmono/mon305.pdf. [11]
    • (1999) , vol.3 , Issue.5 , pp. 11
    • Ukoumunne, O.C.1    Gulliford, M.C.2    Chinn, S.3    Sterne, J.A.C.4    Burney, P.G.J.5
  • 178
    • 0026516454 scopus 로고
    • A randomized trial comparing intravenous immune globulin and plasma exchange in Guillain-Barré syndrome
    • van der Meché, F.G.A. and Schmitz, P.I.M. (1992) A randomized trial comparing intravenous immune globulin and plasma exchange in Guillain-Barré syndrome. New England Journal of Medicine, 326, 1123-1129. [10]
    • (1992) New England Journal of Medicine , vol.326 , pp. 1123-1129
    • van der Meché, F.G.A.1    Schmitz, P.I.M.2
  • 179
    • 84887165223 scopus 로고    scopus 로고
    • Clinical Trials
    • A Practical Guide to Design, Analysis and Reporting, Remedica, London
    • Wang, D. and Bakhai, A. (eds) (2006) Clinical Trials. A Practical Guide to Design, Analysis and Reporting, Remedica, London. [1]
    • (2006) , pp. 1
    • Wang, D.1    Bakhai, A.2
  • 180
    • 0003408447 scopus 로고
    • SF-36 Health Survey Manual and Interpretation Guide
    • New England Medical Centre, Boston, MA
    • Ware, J.E., Snow, K.K., Kosinski, M. and Gandek, B. (1993) SF-36 Health Survey Manual and Interpretation Guide, New England Medical Centre, Boston, MA. [4]
    • (1993) , pp. 4
    • Ware, J.E.1    Snow, K.K.2    Kosinski, M.3    Gandek, B.4
  • 182
    • 43849105857 scopus 로고    scopus 로고
    • Effect of intensive insulin therapy on Β-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial
    • and others
    • Weng, J., Li, Y., Xu, W., Shi, L., Zhang, Q., Zhu, D., Hu, Y. and Zhou, Z. and others (2008) Effect of intensive insulin therapy on Β-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet, 371, 1753-1760. [1, 13]
    • (2008) Lancet , vol.371 , pp. 1753-1760
    • Weng, J.1    Li, Y.2    Xu, W.3    Shi, L.4    Zhang, Q.5    Zhu, D.6    Hu, Y.7    Zhou, Z.8
  • 183
    • 0003801716 scopus 로고    scopus 로고
    • The Design and Analysis of Sequential Clinical Trials
    • revised 2nd edn, John Wiley & Sons, Ltd, Chichester
    • Whitehead, J. (1997) The Design and Analysis of Sequential Clinical Trials, revised 2nd edn, John Wiley & Sons, Ltd, Chichester. [14]
    • (1997) , pp. 14
    • Whitehead, J.1
  • 184
    • 84887157809 scopus 로고    scopus 로고
    • WHO International Clinical Trials Registry Platform: Universal Trial Reference Number (UTRN)
    • WHO
    • WHO (2008) WHO International Clinical Trials Registry Platform: Universal Trial Reference Number (UTRN), www.who.int/ictrp/utrn/en/index.html. [6]
    • (2008) , pp. 6
  • 188
    • 0004103588 scopus 로고    scopus 로고
    • Guidelines for Assessing Quality of Life in EORTC Trials
    • EORTC, Brussels
    • Young, T., de Haes, J.C.J.M., Curran, D., Fayers, P.M. and Brandberg, Y. (1999) Guidelines for Assessing Quality of Life in EORTC Trials, EORTC, Brussels. [14]
    • (1999) , pp. 14
    • Young, T.1    De Haes, J.C.J.M.2    Curran, D.3    Fayers, P.M.4    Brandberg, Y.5
  • 189
    • 0018750520 scopus 로고
    • A new design for randomized clinical trials
    • Zelen, M. (1979) A new design for randomized clinical trials. New England Journal of Medicine, 300, 1242-1245. [14]
    • (1979) New England Journal of Medicine , vol.300 , pp. 1242-1245
    • Zelen, M.1
  • 190
    • 0026696951 scopus 로고
    • Randomised consent trials
    • Zelen, M. (1992) Randomised consent trials. Lancet, 340, 375. [14]
    • (1992) Lancet , vol.340
    • Zelen, M.1
  • 192
    • 33846837894 scopus 로고    scopus 로고
    • Artemether-lumefantrine versus amodiaquine plus sulfadoxinepyrimethamine for uncomplicated falciparum malaria in Burkina Faso: a randomised noinferiority trial
    • Zongo, I., Dorsey, G., Rouamba, N., Tinto, H., Dokomajilar, C., Guiguemde, R.T., Rosenthal, P. and Ouedraogo, J.B. (2007) Artemether-lumefantrine versus amodiaquine plus sulfadoxinepyrimethamine for uncomplicated falciparum malaria in Burkina Faso: a randomised noinferiority trial. Lancet, 369, 491-498. [1, 5, 11]
    • (2007) Lancet , vol.369 , pp. 491-498
    • Zongo, I.1    Dorsey, G.2    Rouamba, N.3    Tinto, H.4    Dokomajilar, C.5    Guiguemde, R.T.6    Rosenthal, P.7    Ouedraogo, J.B.8


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