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  1. This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking ...

    Authors: Sally A Brinkman, Sarah E Johnson, David Lawrence, James P Codde, Michael B Hart, Judith AY Straton and Sven Silburn

    Citation: Trials 2010 11:100

    Content type: Study protocol

    Published on:

  2. Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating dep...

    Authors: Willem Kuyken, Sarah Byford, Richard Byng, Tim Dalgleish, Glyn Lewis, Rod Taylor, Edward R Watkins, Rachel Hayes, Paul Lanham, David Kessler, Nicola Morant and Alison Evans

    Citation: Trials 2010 11:99

    Content type: Study protocol

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  3. Rates of non-completion of treatments for personality disorder are high and there are indications that those who do not complete treatment have worse outcomes than those who do. Improving both cost-efficiency ...

    Authors: Mary McMurran, W Miles Cox, Stephen Coupe, Diane Whitham and Lucy Hedges

    Citation: Trials 2010 11:98

    Content type: Study protocol

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  4. Depression and bipolar disorder are associated with reduced neural plasticity and deficits in memory, attention and executive function. Drug treatments for these affective disorders have insufficient clinical ...

    Authors: Kamilla W Miskowiak, Maj Vinberg, Catherine J Harmer, Hannelore Ehrenreich, Gitte M Knudsen, Julian Macoveanu, Allan R Hansen, Olaf B Paulson, Hartwig R Siebner and Lars V Kessing

    Citation: Trials 2010 11:97

    Content type: Study protocol

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  5. Depressive disorders are highly prevalent in primary care (PC) and are associated with considerable functional impairment and increased health care use. Research has shown that many patients prefer psychologic...

    Authors: Kim D Baas, Maarten WJ Koeter, Henk C van Weert, Peter Lucassen, Claudi LH Bockting, Karin A Wittkampf and Aart H Schene

    Citation: Trials 2010 11:96

    Content type: Study protocol

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  6. Many patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure t...

    Authors: Michele Heisler, Timothy P Hofer, Mandi L Klamerus, Julie Schmittdiel, Joe Selby, Mary M Hogan, Hayden B Bosworth, Adam Tremblay and Eve A Kerr

    Citation: Trials 2010 11:95

    Content type: Study protocol

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  7. Weight gain accompanies smoking cessation, but dieting during quitting is controversial as hunger may increase urges to smoke. This is a feasibility trial for the investigation of a very low calorie diet (VLCD...

    Authors: Deborah Lycett, Peter Hajek and Paul Aveyard

    Citation: Trials 2010 11:94

    Content type: Study protocol

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  8. Improving the health of school-aged children can yield substantial benefits for cognitive development and educational achievement. However, there is limited experimental evidence on the benefits of school-base...

    Authors: Simon Brooker, George Okello, Kiambo Njagi, Margaret M Dubeck, Katherine E Halliday, Hellen Inyega and Matthew CH Jukes

    Citation: Trials 2010 11:93

    Content type: Study protocol

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  9. Besides cognitive decline, Alzheimer's disease (AD) leads to physical disability, need for help and permanent institutional care. The trials investigating effects of exercise rehabilitation on physical functio...

    Authors: Kaisu H Pitkala, Minna M Raivio, Marja-Liisa Laakkonen, Reijo S Tilvis, Hannu Kautiainen and Timo E Strandberg

    Citation: Trials 2010 11:92

    Content type: Study protocol

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  10. New-onset diabetes mellitus after transplantation (NODAT), a frequent and serious complication after transplantation, is associated with decreased graft and patient survival. Currently, it is diagnosed and tre...

    Authors: Michael Haidinger, Johannes Werzowa, Hans-Christian Voigt, Johannes Pleiner, Gunar Stemer, Manfred Hecking, Dominik Döller, Walter H Hörl, Thomas Weichhart and Marcus D Säemann

    Citation: Trials 2010 11:91

    Content type: Study protocol

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  11. The purpose of clinical trials of acupuncture is to help clinicians and patients make decisions about treatment. Yet this is not straightforward: some trials report acupuncture to be superior to sham (placebo)...

    Authors: Andrew J Vickers, Angel M Cronin, Alexandra C Maschino, George Lewith, Hugh Macpherson, Norbert Victor, Karen J Sherman, Claudia Witt and Klaus Linde

    Citation: Trials 2010 11:90

    Content type: Study protocol

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  12. In the setting of primary percutaneous coronary intervention, patients with a chronic total occlusion in a non-infarct related artery were recently identified as a high-risk subgroup. It is unclear whether ST-...

    Authors: René J van der Schaaf, Bimmer E Claessen, Loes P Hoebers, Niels J Verouden, Jacques J Koolen, Maarten J Suttorp, Emanuele Barbato, Matthijs Bax, Bradley H Strauss, Göran K Olivecrona, Vegard Tuseth, Dietmar Glogar, Truls Råmunddal, Jan G Tijssen, Jan J Piek and José PS Henriques

    Citation: Trials 2010 11:89

    Content type: Study protocol

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  13. The UN Millennium Development Goals call for substantial reductions in maternal and child mortality, to be achieved through reductions in morbidity and mortality during pregnancy, delivery, postpartum and earl...

    Authors: Sonia Lewycka, Charles Mwansambo, Peter Kazembe, Tambosi Phiri, Andrew Mganga, Mikey Rosato, Hilda Chapota, Florida Malamba, Stefania Vergnano, Marie-Louise Newell, David Osrin and Anthony Costello

    Citation: Trials 2010 11:88

    Content type: Study protocol

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  14. Current guidelines recommend dual anti-platelet therapy, aspirin and clopidogrel, for patients treated with drug-eluting stent for coronary heart disease. In a few small trials, addition of cilostazol on dual ...

    Authors: Seung-Pyo Lee, Jung-Won Suh, Kyung Woo Park, Hae-Young Lee, Hyun-Jae Kang, Bon-Kwon Koo, In-Ho Chae, Dong-Ju Choi, Seung-Woon Rha, Jang-Whan Bae, Myeong-Chan Cho, Taek-Geun Kwon, Jang-Ho Bae and Hyo-Soo Kim

    Citation: Trials 2010 11:87

    Content type: Study protocol

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  15. Treatment with Androgen Deprivation Therapy (ADT) for prostate cancer is associated with changes in body composition including increased fat and decreased lean mass; increased fatigue, and a reduction in quali...

    Authors: Farhana Haseen, Liam J Murray, Roisin F O'Neill, Joe M O'Sullivan and Marie M Cantwell

    Citation: Trials 2010 11:86

    Content type: Study protocol

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  16. Mounting evidence suggests that there is frequently considerable variation in the risk of the outcome of interest in clinical trial populations. These differences in risk will often cause clinically important ...

    Authors: David M Kent, Peter M Rothwell, John PA Ioannidis, Doug G Altman and Rodney A Hayward

    Citation: Trials 2010 11:85

    Content type: Methodology

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  17. Seasonal allergic rhinitis (hayfever) is common and can contribute to a considerable reduction in the quality of life of adolescents. This study aims to examine the effectiveness of standardised allergy traini...

    Authors: Victoria S Hammersley, Samantha Walker, Rob Elton and Aziz Sheikh

    Citation: Trials 2010 11:84

    Content type: Study protocol

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  18. Functional dyspepsia (FD) is characterized by a high prevalence rate and no standard conventional treatments. Alternative therapies, such as herbal formulas, are widely used to treat FD. However, there are ina...

    Authors: Jae-Woo Park, Bongha Ryu, Inkwon Yeo, Ui-Min Jerng, Gajin Han, Sunghwan Oh, Jinsoo Lee and Jinsung Kim

    Citation: Trials 2010 11:83

    Content type: Study protocol

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  19. With the increase in the elderly population, a growing number of chronic degenerative diseases and a greater dependency on caregivers have been observed. Elderly persons in states of frailty remain more suscep...

    Authors: Lygia P Lustosa, Fernanda M Coelho, Juscelio P Silva, Daniele S Pereira, Adriana N Parentoni, João MD Dias, Rosangela C Dias and Leani SM Pereira

    Citation: Trials 2010 11:82

    Content type: Study protocol

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  20. Patients with early stage papillary thyroid carcinoma (PTC), are faced with the decision to either to accept or reject adjuvant radioactive iodine (RAI) treatment after thryroidectomy. This decision is often d...

    Authors: Anna M Sawka, Sharon Straus, James D Brierley, Richard W Tsang, Lorne Rotstein, Gary Rodin, Amiram Gafni, Shereen Ezzat, Lehana Thabane, Kevin E Thorpe and David P Goldstein

    Citation: Trials 2010 11:81

    Content type: Study protocol

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  21. This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design.

    Authors: Michael Teut, Ute Hirschberg, Rainer Luedtke, Cristoph Schnegg, Joern Dahler, Henning Albrecht and Claudia M Witt

    Citation: Trials 2010 11:80

    Content type: Study protocol

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  22. The use of Clinical Data Management Systems (CDMS) has become essential in clinical trials to handle the increasing amount of data that must be collected and analyzed. With a CDMS trial data are captured at in...

    Authors: Wolfgang Kuchinke, Christian Ohmann, Qin Yang, Nader Salas, Jens Lauritsen, Francois Gueyffier, Alan Leizorovicz, Carmen Schade-Brittinger, Michael Wittenberg, Zoltán Voko, Siobhan Gaynor, Margaret Cooney, Peter Doran, Aldo Maggioni, Andrea Lorimer, Ferràn Torres…

    Citation: Trials 2010 11:79

    Content type: Research

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  23. Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evalua...

    Authors: Barbara Farrell, Sara Kenyon and Haleema Shakur

    Citation: Trials 2010 11:78

    Content type: Review

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  24. In the course of producing the 2009 NHS Evidence - skin disorders Annual Evidence Update on Acne Vulgaris, 25 randomised controlled trials were examined. From these, at least 12 potentially serious problems of...

    Authors: John R Ingram, Douglas JC Grindlay and Hywel C Williams

    Citation: Trials 2010 11:77

    Content type: Commentary

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  25. Traditional randomized controlled trials are considered the gold standard for evaluating the efficacy of a treatment. However, in adherence research, limitations to this study design exist, especially when eva...

    Authors: Charity D Evans, Dean T Eurich, Jeff G Taylor, Alfred J Remillard, Yvonne M Shevchuk and David F Blackburn

    Citation: Trials 2010 11:76

    Content type: Study protocol

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  26. Due to language limitations, the abstract of journal article may be the only way for people of non-Chinese speaking countries to know about trials in traditional Chinese medicine (TCM). However, little is know...

    Authors: Ling Wang, Yulin Li, Jing Li, Mingming Zhang, Lin Xu, Wenming Yuan, Gang Wang and Sally Hopewell

    Citation: Trials 2010 11:75

    Content type: Methodology

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  27. Stroke is one of the most disabling and costly impairments of adulthood in the United States. Stroke patients clearly benefit from intensive inpatient care, but due to the high cost, there is considerable inte...

    Authors: Neale R Chumbler, Dorian K Rose, Patricia Griffiths, Patricia Quigley, Nancy McGee-Hernandez, Katherine A Carlson, Phyllis Vandenberg, Miriam C Morey, Jon Sanford and Helen Hoenig

    Citation: Trials 2010 11:74

    Content type: Study protocol

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  28. Quality of residential care for people with severe dementia is in urgent need of improvement. One reason for this may be the assumption that people with severe dementia are unaware of what is happening to them...

    Authors: Linda Clare, Robert T Woods, Rhiannon Whitaker, Barbara A Wilson and Murna Downs

    Citation: Trials 2010 11:73

    Content type: Study protocol

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  29. The challenge of Bipolar Disorder (BD) treatment is due to the complexity of the disease. Current guidelines represent an effort to help clinicians in their everyday practice but still have limitations, specia...

    Authors: Rodolfo N Campos, Luis F Costa, Danielle S Bio, Márcio G Soeiro de Souza, Carla RL Garcia, Frederico N Demétrio, Doris H Moreno and Ricardo A Moreno

    Citation: Trials 2010 11:72

    Content type: Study protocol

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  30. A recent Cochrane Review demonstrated the remarkable lack of reliable clinical trials of migraine treatments for children, especially for the two most prescribed preventative treatments in the UK, Propranolol and...

    Authors: Paul Silcocks, Diane Whitham and William Patrick Whitehouse

    Citation: Trials 2010 11:71

    Content type: Study protocol

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  31. Anemia is a risk factor for death, adverse cardiovascular outcomes and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESA) are commonly used to increase ...

    Authors: Giovanni FM Strippoli

    Citation: Trials 2010 11:70

    Content type: Study protocol

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  32. Acute infectious diseases are major causes of short periods of days off from work, day care and school. These diseases are mainly caused by viruses and hands have a key role in their transmission. Thus, hypoth...

    Authors: Carita Savolainen-Kopra, Jaason Haapakoski, Piia A Peltola, Thedi Ziegler, Terttu Korpela, Pirjo Anttila, Ali Amiryousefi, Pentti Huovinen, Markku Huvinen, Heikki Noronen, Pia Riikkala, Merja Roivainen, Petri Ruutu, Juha Teirilä, Erkki Vartiainen and Tapani Hovi

    Citation: Trials 2010 11:69

    Content type: Study protocol

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  33. The optimization of preventive strategies in patients at high risk of cardiovascular events and the evaluation of bottlenecks and limitations of transferring current guidelines to the real world of clinical pr...

    Authors:

    Citation: Trials 2010 11:68

    Content type: Study protocol

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  34. Screening for abdominal aortic aneurysm (AAA) of men aged 65-74 years reduces the AAA-related mortality and is generally considered cost effective. Despite of this only a few national health care services have...

    Authors: Nikolaj Grøndal, Rikke Søgaard, Eskild W Henneberg and Jes S Lindholt

    Citation: Trials 2010 11:67

    Content type: Study protocol

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  35. Our objective was to report on the design and essentials of the Etoricoxib protocol- Preemptive and Postoperative Analgesia (EPPA) Trial, investigating whether preemptive analgesia with cox-2 inhibitors is more e...

    Authors: Johannes Fleckenstein, Sybille Kramer, Martin Offenbächer, Gabriel Schober, Herbert Plischke, Matthias Siebeck, Thomas Mussack, Rudolf Hatz, Lukas Lehmeyer, Philip M Lang, Bernhard Heindl, Peter Conzen and Dominik Irnich

    Citation: Trials 2010 11:66

    Content type: Study protocol

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  36. The subject of death and bereavement in the context of randomised controlled trials in neonatal or paediatric intensive care is under-researched. The objectives of this phase of the Bereavement and RAndomised ...

    Authors: Claire Snowdon, Sheila E Harvey, Peter Brocklehurst, Robert C Tasker, Martin P Ward Platt, Elizabeth Allen and Diana Elbourne

    Citation: Trials 2010 11:65

    Content type: Research

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  37. Public confidence in clinical trials has been eroded by data suppression, misrepresentation and manipulation. Although various attempts have been made to achieve universal trial registration- e.g., Declaration...

    Authors: Zhao-Xiang Bian and Tai-Xiang Wu

    Citation: Trials 2010 11:64

    Content type: Commentary

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  38. There is scope to improve the quality of life (QOL) of people with dementia living in residential care facilities (RCF). The DIRECT study will determine if delivery of education to General Practitioners (GPs) ...

    Authors: Christopher D Beer, Barbara Horner, Osvaldo P Almeida, Samuel Scherer, Nicola T Lautenschlager, Nick Bretland, Penelope Flett, Frank Schaper and Leon Flicker

    Citation: Trials 2010 11:63

    Content type: Study protocol

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  39. The standard of care for colorectal peritoneal carcinomatosis is evolving from chemotherapy to cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with disease limit...

    Authors: Robert T Ripley, Jeremy L Davis, Clinton D Kemp, Seth M Steinberg, Mary Ann Toomey and Itzhak Avital

    Citation: Trials 2010 11:62

    Content type: Study protocol

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  40. Statins have been proved to be effective in reduction of mortality and morbidity when started in the early secondary prevention in stabilized patients after acute coronary syndrome (ACS). The safety and effica...

    Authors: Petr Ostadal, David Alan, Jiri Vejvoda, Jiri Kukacka, Milan Macek, Petr Hajek, Martin Mates, Milan Kvapil, Jiri Kettner, Martin Wiendl, Ondrej Aschermann, Josef Slaby, Frantisek Holm, Peter Telekes, David Horak, Peter Blasko…

    Citation: Trials 2010 11:61

    Content type: Research

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  41. Associated with a tripling in obesity since 1970, type 2 diabetes mellitus (T2DM) in children has risen 9-10 fold. There is a critical need of protocols for trials to prevent T2DM in children.

    Authors: Lorrene D Ritchie, Sushma Sharma, Joanne P Ikeda, Rita A Mitchell, Aarthi Raman, Barbara S Green, Mark L Hudes and Sharon E Fleming

    Citation: Trials 2010 11:60

    Content type: Study protocol

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  42. To evaluate the use and reporting of adjusted analysis in randomised controlled trials (RCTs) and compare the quality of reporting before and after the revision of the CONSORT Statement in 2001.

    Authors: Ly-Mee Yu, An-Wen Chan, Sally Hopewell, Jonathan J Deeks and Douglas G Altman

    Citation: Trials 2010 11:59

    Content type: Review

    Published on:

  43. Tackling neonatal mortality is essential for the achievement of the child survival millennium development goal. There are just under 4 million neonatal deaths, accounting for 38% of the 10.8 million deaths amo...

    Authors: Betty R Kirkwood, Alexander Manu, Charlotte Tawiah-Agyemang, Guus ten Asbroek, Thomas Gyan, Benedict Weobong, R Eric Lewandowski, Seyi Soremekun, Samuel Danso, Catherine Pitt, Kara Hanson, Seth Owusu-Agyei and Zelee Hill

    Citation: Trials 2010 11:58

    Content type: Study protocol

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  44. Chest pain is a common presenting complaint in the emergency department (ED). Despite the frequency with which clinicians evaluate patients with chest pain, accurately determining the risk of acute coronary sy...

    Authors: Meghan A Pierce, Erik P Hess, Jeffrey A Kline, Nilay D Shah, Maggie Breslin, Megan E Branda, Laurie J Pencille, Brent R Asplin, David M Nestler, Annie T Sadosty, Ian G Stiell, Henry H Ting and Victor M Montori

    Citation: Trials 2010 11:57

    Content type: Study protocol

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  45. Chronic (systolic) heart failure (CHF) represents a clinical syndrome with high individual and societal burden of disease. Multifaceted interventions like case management are seen as promising ways of improvin...

    Authors: Frank Peters-Klimm, Stephen Campbell, Katja Hermann, Cornelia U Kunz, Thomas Müller-Tasch and Joachim Szecsenyi

    Citation: Trials 2010 11:56

    Content type: Research

    Published on:

  46. Almost all of the 820,000 people in the UK with dementia will experience Behavioural and Psychological Symptoms of Dementia (BPSD). However, research has traditionally focused on treating cognitive symptoms, t...

    Authors: Arlinda Cerga-Pashoja, David Lowery, Rahul Bhattacharya, Mark Griffin, Steve Iliffe, James Lee, Claire Leonard, Sue Ricketts, Lyn Strother, Fiona Waters, Craig W Ritchie and James Warner

    Citation: Trials 2010 11:53

    Content type: Study protocol

    Published on:

  47. Outcome reporting bias (ORB) occurs when variables are selected for publication based on their results. This can impact upon the results of a meta-analysis, biasing the pooled treatment effect estimate.

    Authors: Kerry Dwan, Carrol Gamble, Ruwanthi Kolamunnage-Dona, Shabana Mohammed, Colin Powell and Paula R Williamson

    Citation: Trials 2010 11:52

    Content type: Methodology

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  48. Thrombolysis with intravenous rt-PA is currently the only approved acute therapy for ischemic stroke. Re-occlusion after initial recanalization occurs in up to 34% in patients treated with rt-PA, probably caus...

    Authors: SM Zinkstok, M Vermeulen, J Stam, RJ de Haan and YB Roos

    Citation: Trials 2010 11:51

    Content type: Study protocol

    Published on:

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