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  1. Clinically useful treatment moderators of Major Depressive Disorder (MDD) have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identif...

    Authors: Leanne M Williams, A John Rush, Stephen H Koslow, Stephen R Wisniewski, Nicholas J Cooper, Charles B Nemeroff, Alan F Schatzberg and Evian Gordon

    Citation: Trials 2011 12:4

    Content type: Study protocol

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  2. Pregnant women living with HIV (WLH) face daily challenges maintaining their own and their babies' health and mental health. Standard Prevention of Maternal to Child Transmission (PMTCT) programs are not desig...

    Authors: Mary-Jane Rotheram-Borus, Linda Richter, Heidi Van Rooyen, Alastair van Heerden, Mark Tomlinson, Alan Stein, Tamsen Rochat, Julia de Kadt, Nonhle Mtungwa, Lungile Mkhize, Lindo Ndlovu, Lungile Ntombela, W Scott Comulada, Katherine A Desmond and Erin Greco

    Citation: Trials 2011 12:2

    Content type: Study protocol

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  3. The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telepho...

    Authors: Jesia G Berry, Philip Ryan, Annette J Braunack-Mayer, Katherine M Duszynski, Vicki Xafis and Michael S Gold

    Citation: Trials 2011 12:1

    Content type: Study protocol

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  4. It has been demonstrated that cognitive behavioural therapy (CBT) has a moderate effect on symptom reduction and on general well being of patients suffering from psychosis. However, questions regarding the spe...

    Authors: Stefan Klingberg, Andreas Wittorf, Christoph Meisner, Wolfgang Wölwer, Georg Wiedemann, Jutta Herrlich, Andreas Bechdolf, Bernhard W Müller, Gudrun Sartory, Michael Wagner, Tilo Kircher, Hans-Helmut König, Corinna Engel and Gerhard Buchkremer

    Citation: Trials 2010 11:123

    Content type: Study protocol

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  5. Contrast-induced nephropathy (CIN) is a serious clinical problem associated with increased morbidity and mortality, particularly in patients with chronic renal insufficiency. Although some agents including hyd...

    Authors: Kyungil Park, Woo-Young Chung, Jae-Bin Seo, Sang-Hyun Kim, Joo-Hee Zo, Myung-A Kim and Young-Bae Park

    Citation: Trials 2010 11:122

    Content type: Study protocol

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  6. Asthma is a major health problem and has significant mortality around the world. Although the symptoms can be controlled by drug treatment in most patients, effective low-risk, non-drug strategies could consti...

    Authors: Rixin Chen, Mingren Chen, Jun Xiong, Fan Yi, Zhenhai Chi and Bo Zhang

    Citation: Trials 2010 11:121

    Content type: Study protocol

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  7. Observational studies have documented a potential protective effect of physical exercise in older adults who are at risk for developing Alzheimer's disease. The Fitness for the Ageing Brain II (FABS II) study ...

    Authors: Elizabeth V Cyarto, Kay L Cox, Osvaldo P Almeida, Leon Flicker, David Ames, Gerard Byrne, Keith D Hill, Christopher D Beer, Dina LoGiudice, Kana Appadurai, Muireann Irish, Emma Renehan and Nicola T Lautenschlager

    Citation: Trials 2010 11:120

    Content type: Study protocol

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  8. Given the increase in overweight and obesity prevalence in adolescents in the last decade, effective prevention strategies for these conditions in adolescents are urgently needed. The PRALIMAP (Promotion de l'...

    Authors: Serge Briançon, Emilie Bonsergent, Nelly Agrinier, Sabrina Tessier, Karine Legrand, Edith Lecomte, Evelyne Aptel, Serge Hercberg and Jean-François Collin

    Citation: Trials 2010 11:119

    Content type: Study protocol

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  9. In low-income countries, only about a third of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) patients eligible for anti-retroviral treatment currently receive it. Providing decent...

    Authors: Michael J Schull, Hastings Banda, Damson Kathyola, Lara Fairall, Alexandra Martiniuk, Barry Burciul, Merrick Zwarenstein, Sumeet Sodhi, Sandy Thompson, Martias Joshua, Martha Mondiwa and Eric Bateman

    Citation: Trials 2010 11:118

    Content type: Study protocol

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  10. Hospital acquired infections are a major cause of morbidity and mortality and markedly increased health care costs. Critically ill patients who require management in an Intensive Care Unit are particularly sus...

    Authors: BH Cuthbertson, J Francis, MK Campbell, L MacIntyre, I Seppelt and J Grimshaw

    Citation: Trials 2010 11:117

    Content type: Study protocol

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  11. Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be ...

    Authors: Stephen Brealey, Lazaros Andronis, Laura Dennis, Christine Atwell, Stirling Bryan, Simon Coulton, Helen Cox, Ben Cross, Fiona Fylan, Andrew Garratt, Fiona Gilbert, Maureen Gillan, Maggie Hendry, Kerenza Hood, Helen Houston, David King…

    Citation: Trials 2010 11:116

    Content type: Research

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  12. Caring for a person with progressive cancer creates challenges for caregivers. However the needs of caregivers are often not assessed or recognised by health care providers. Research is also lacking in this ar...

    Authors: Geoffrey Mitchell, Afaf Girgis, Moyez Jiwa, David Sibbritt and Letitia Burridge

    Citation: Trials 2010 11:115

    Content type: Study protocol

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  13. Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Relatively few adolescents with depression are identi...

    Authors: Paul Stallard, Alan A Montgomery, Ricardo Araya, Rob Anderson, Glynn Lewis, Kapil Sayal, Rhiannon Buck, Abigail Millings and John A Taylor

    Citation: Trials 2010 11:114

    Content type: Study protocol

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  14. Although highly active antiretroviral therapy (HAART) has dramatically decreased HIV-related morbidity and mortality, the associated costs, toxicities, and resistance risks make the potential delay of HAART in...

    Authors: Darrell H S Tan, Janet M Raboud, Rupert Kaul, Beatriz Grinsztejn, Pedro Cahn and Sharon L Walmsley

    Citation: Trials 2010 11:113

    Content type: Study protocol

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  15. Hospital treatment of chronic obstructive pulmonary disease (COPD) frequently does not follow published evidences. This lack of adherence can contribute to the high morbidity, mortality and readmissions rates....

    Authors: Kris Vanhaecht, Walter Sermeus, Jan Peers, Cathy Lodewijckx, Svin Deneckere, Fabrizio Leigheb, Marc Decramer and Massimiliano Panella

    Citation: Trials 2010 11:111

    Content type: Study protocol

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  16. Haemostasis in liver surgery remains a challenge despite improved resection techniques. Oozing from blood vessels too small to be ligated necessitate a treatment with haemostats in order to prevent complicatio...

    Authors: Christian Moench, Wolf O Bechstein, Valentin Hermanutz, Godehard Hoexter and Hanns-Peter Knaebel

    Citation: Trials 2010 11:109

    Content type: Study protocol

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  17. There is currently much interest in pharmacogenetics: determining variation in genes that regulate drug effects, with a particular emphasis on improving drug safety and efficacy. The ability to determine such ...

    Authors: Benjamin French, Jungnam Joo, Nancy L Geller, Stephen E Kimmel, Yves Rosenberg, Jeffrey L Anderson, Brian F Gage, Julie A Johnson and Jonas H Ellenberg

    Citation: Trials 2010 11:108

    Content type: Methodology

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  18. Previous studies of acupuncture show favourable results for both subjective and objective outcomes of dry eye. However, firm conclusions could not be drawn from these studies because the quality of the trials ...

    Authors: Tae-Hun Kim, Jung Won Kang, Kun Hyung Kim, Kyung-Won Kang, Mi-Suk Shin, So-Young Jung, Ae-Ran Kim, Hee-Jung Jung, Seung-Deok Lee, Jin-Bong Choi and Sun-Mi Choi

    Citation: Trials 2010 11:107

    Content type: Study protocol

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  19. Hypothyroidism is a prevalent endocrine condition. Individuals with this disease are commonly managed through supplementation with synthetic thyroid hormone, with the aim of alleviating symptoms and restoring ...

    Authors: Benjamin T Brown, Rod Bonello, Henry Pollard and Petra Graham

    Citation: Trials 2010 11:106

    Content type: Study protocol

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  20. Depression is one of the most common reasons for consulting a General Practitioner (GP) within the UK. Whilst antidepressants have been shown to be clinically effective, many patients and healthcare profession...

    Authors: Helen Baxter, Rachel Winder, Melanie Chalder, Christine Wright, Sofie Sherlock, Anne Haase, Nicola J Wiles, Alan A Montgomery, Adrian H Taylor, Ken R Fox, Debbie A Lawlor, Tim J Peters, Deborah J Sharp, John Campbell and Glyn Lewis

    Citation: Trials 2010 11:105

    Content type: Study protocol

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  21. 'Compassionate use' programmes allow medicinal products that are not authorised, but are in the development process, to be made available to patients with a severe disease who have no other satisfactory treatm...

    Authors: Kate Whitfield, Karl-Heinz Huemer, Diana Winter, Steffen Thirstrup, Christian Libersa, Béatrice Barraud, Christine Kubiak, Lea Stankovski, Xina Grählert, Gabriele Dreier, Sebastian Geismann, Wolfgang Kuchinke, Anke Strenge-Hesse, Zsuza Temesvari, Gyorgy Blasko, Gabriella Kardos…

    Citation: Trials 2010 11:104

    Content type: Research

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  22. Chronic cough is common and is associated with significant economic and human costs. While cough can be a problematic symptom without serious consequences, it could also reflect a serious underlying illness. E...

    Authors: AB Chang, CF Robertson, PP van Asperen, NJ Glasgow, IB Masters, CM Mellis, LI Landau, L Teoh and PS Morris

    Citation: Trials 2010 11:103

    Content type: Study protocol

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  23. The use of compulsory treatment under the Mental Health Act (MHA) has continued to rise in the UK and in other countries. The Joint Crisis Plan (JCP) is a statement of service users' wishes for treatment in th...

    Authors: Graham Thornicroft, Simone Farrelly, Max Birchwood, Max Marshall, George Szmukler, Waquas Waheed, Sarah Byford, Graham Dunn, Claire Henderson, Helen Lester, Morven Leese, Diana Rose and Kim Sutherby

    Citation: Trials 2010 11:102

    Content type: Study protocol

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  24. The Turkish population living in the Netherlands has a high prevalence of psychological complaints and has a high threshold for seeking professional help for these problems. Seeking help through the Internet c...

    Authors: Burçin Ünlü, Heleen Riper, Annemieke van Straten and Pim Cuijpers

    Citation: Trials 2010 11:101

    Content type: Study protocol

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  25. 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:

  26. 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

    Published on:

  27. 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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  28. 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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  29. 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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  30. 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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  31. 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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  32. 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

    Published on:

  33. 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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  34. 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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  35. 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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  36. 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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  37. 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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  38. 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

    Published on:

  39. 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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  40. 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

    Published on:

  41. 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

    Published on:

  42. 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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  43. 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

    Published on:

  44. 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

    Published on:

  45. 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

    Published on:

  46. 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

    Published on:

  47. 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

    Published on:

  48. 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

    Published on:

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