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  1. Adaptive designs offer a flexible approach, allowing changes to a trial based on examinations of the data as it progresses. Adaptive clinical trials are becoming a popular choice, as the prudent use of finite ...

    Authors: Laura Flight, Steven Julious, Alan Brennan, Susan Todd and Daniel Hind

    Citation: Trials 2020 21:252

    Content type: Research

    Published on:

  2. After publication of our article [1] the authors have notified us that one of the names has been incorrectly spelled.

    Authors: Soobin Jang, Hyun Kyung Sung, Mi Mi Ko, Seon Mi Shin, Ho-Yeon Go and Jeeyoun Jung

    Citation: Trials 2020 21:250

    Content type: Correction

    Published on:

    The original article was published in Trials 2020 21:193

  3. The aim of this study is to demonstrate that capecitabine metronomic chemotherapy is non-inferior to capecitabine conventional chemotherapy as maintenance treatment, in patients who have responded to 16–18 wee...

    Authors: Min Shi, Tao Ma, Wenqi Xi, Jinling Jiang, Junwei Wu, Chenfei Zhou, Chen Yang, Zhenggang Zhu and Jun Zhang

    Citation: Trials 2020 21:249

    Content type: Study protocol

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  4. Shoulder impingement syndrome is one of the most common causes of shoulder pain, accounting for approximately 30% of all shoulder pain. Approximately 35% of patients with shoulder impingement syndrome are refr...

    Authors: Travis Cleland, Nitin B. Jain, John Chae, Kristine M. Hansen, Terri Z. Hisel, Douglas D. Gunzler, Victoria C. Whitehair, Chong H. Kim and Richard D. Wilson

    Citation: Trials 2020 21:248

    Content type: Study protocol

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  5. Complications of preterm birth cause more than 1 million deaths each year, mostly within the first day after birth (47%) and before full post-natal stabilisation. Kangaroo mother care (KMC), provided as contin...

    Authors: Helen Brotherton, Abdou Gai, Cally J. Tann, Ahmadou Lamin Samateh, Anna C. Seale, Syed M. A. Zaman, Simon Cousens, Anna Roca and Joy E. Lawn

    Citation: Trials 2020 21:247

    Content type: Study protocol

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  6. We aimed to assess the patient experience of informed consent (IC) during acute myocardial infarction (AMI) in a sub-study of the VALIDATE-SWEDEHEART trial. The original trial compared two anticoagulant agents...

    Authors: Anneli Olsson, Camilla Ring, Johan Josefsson, Annika Eriksson, Rebecca Rylance, Ole Fröbert, Stefan James, David Sparv and David Erlinge

    Citation: Trials 2020 21:246

    Content type: Research

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  7. Antipsychotic drug-induced weight gain puts individuals with schizophrenia at increased cardiometabolic risk. As a potential intervention for this problem, we describe the theoretical background and a protocol...

    Authors: Luiza Grycuk, Gemma Gordon, Fiona Gaughran, Iain C. Campbell and Ulrike Schmidt

    Citation: Trials 2020 21:245

    Content type: Study protocol

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  8. There are difficulties in carrying out research in low-income urban communities, but the methodological challenges and suggestions on how to deal with them are often undocumented. The aims of this study are to...

    Authors: Amanda Rodrigues Amorim Adegboye, Paula G. Cocate, Camila Benaim, Maria Claudia da Veiga Soares Carvalho, Michael M. Schlüssel, Maria Beatriz T. de Castro, Gilberto Kac and Berit L. Heitmann

    Citation: Trials 2020 21:244

    Content type: Research

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  9. Atopic dermatitis (AD) is a common, chronic skin disorder often beginning in infancy. Skin barrier dysfunction early in life serves as a central event in the pathogenesis of AD. In infants at high risk of deve...

    Authors: Brian Eichner, Le Ann C. Michaels, Kelsey Branca, Katrina Ramsey, Julie Mitchell, Cynthia D. Morris, Lyle J. Fagnan, Rowena J. Dolor, Nancy Elder, David L. Hahn, Donald E. Nease, Jodi Lapidus, Ricardo Cibotti, Julie Block and Eric L. Simpson

    Citation: Trials 2020 21:243

    Content type: Study protocol

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  10. Acute respiratory distress syndrome (ARDS) is caused by rapid-onset (within hours) acute inflammatory processes in lung tissue, and it is a life-threatening condition with high mortality. The treatment of ARDS...

    Authors: Helene Haeberle, Stefanie Prohaska, Peter Martus, Andreas Straub, Alexander Zarbock, Gernot Marx, Manola Zago, Martin Giera, Michael Koeppen and Peter Rosenberger

    Citation: Trials 2020 21:242

    Content type: Study protocol

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  11. Researchers often rely on trial participants to self-report clinical outcomes (for example, fractures, re-operations). Little information exists as to the ‘accuracy’ of participant-reported clinical outcomes, ...

    Authors: Suzanne Breeman, Lynda Constable, Anne Duncan, Kath Starr, Alison McDonald, Samantha Wileman and Seonaidh Cotton

    Citation: Trials 2020 21:241

    Content type: Research

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  12. Hospital to home transition care is a most stressful period for stroke survivors and their caregivers to learn self-management of stroke-related health conditions and to engage in rehabilitation. Health coachi...

    Authors: Shuanglan Lin, Lily Dongxia Xiao and Diane Chamberlain

    Citation: Trials 2020 21:240

    Content type: Study protocol

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  13. Traditional Chinese medicine (TCM) usually involves syndrome differentiation and treatment. Acupuncture, one form of TCM, requires the selection of appropriate acupoints and needling techniques, but many clini...

    Authors: Shiya Huang, Min Hu, Ernest Hung Yu Ng, Elisabet Stener-Victorin, Yanhua Zheng, Qidan Wen, Cong Wang, Maohua Lai, Juan Li, Xingcheng Gao, Xinhua Wang, Zhenxing Hu, Tian Xia, Rongkui Hu, Jianping Liu, Xiaohui Wen…

    Citation: Trials 2020 21:239

    Content type: Study protocol

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  14. Single-sided deafness (SSD) describes the presence of a unilateral severe to profound sensorineural hearing loss. SSD disrupts spatial hearing and understanding speech in background noise. It has functional, p...

    Authors: Roulla Katiri, Deborah A. Hall, Nora Buggy, Nicholas Hogan, Adele Horobin, Paul van de Heyning, Jill B. Firszt, Iain A. Bruce and Pádraig T. Kitterick

    Citation: Trials 2020 21:238

    Content type: Study protocol

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  15. Dysphagia is a common and serious complication after (chemo)radiotherapy (CRT) for head-and-neck cancer (HNC) patients. Prophylactic swallowing exercises (PSE) can have a significantly positive effect on post-...

    Authors: Margot Baudelet, Leen Van den Steen, Fréderic Duprez, Marc De Bodt, Sarah Deschuymer, Ann Goeleven, Isabel Hutsebaut, Steven Mariën, Sabine Meersschout, Daan Nevens, Sandra Nuyts, Marc Peeters, Pol Specenier, Michiel Van den Brekel, Lisette van der Molen, Caroline Vandenbruaene…

    Citation: Trials 2020 21:237

    Content type: Study protocol

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  16. Law enforcement officers (LEOs) are exposed to significant stressors, elevating their risk for aggression and excessive use of force, as well as mental health consequences, including post-traumatic stress diso...

    Authors: Michael Christopher, Sarah Bowen and Katie Witkiewitz

    Citation: Trials 2020 21:236

    Content type: Study protocol

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  17. In cardiac surgery with cardiopulmonary bypass (CPB), large amounts of fluids are administered. CPB priming with crystalloid solution causes marked hemodilution and fluid extravasation. Colloid solutions may r...

    Authors: Hanna Vlasov, Tatu Juvonen, Seppo Hiippala, Raili Suojaranta, Markku Peltonen, Alexey Schramko, Kaapo Arvonen, Ulla-Stina Salminen, Ilona Kleine Budde, Tiina Eränen, Maxim Mazanikov, Mihkel Meinberg, Tommi Vähäsilta, Erika Wilkman, Ville Pettilä and Eero Pesonen

    Citation: Trials 2020 21:235

    Content type: Study protocol

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  18. Measures shown to improve outcomes for patients often fail to be adopted into routine practice in the NHS. The Institute for Health Improvement Breakthrough Series Collaborative (BSC) model is designed to supp...

    Authors: Ashley B Scrimshire, Alison Booth, Caroline Fairhurst, Mike Reed, Win Tadd, Annie Laverty, Belen Corbacho, David Torgerson and Catriona McDaid

    Citation: Trials 2020 21:234

    Content type: Study protocol

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  19. Studies have suggested that fluoxetine might improve neurological recovery after stroke, but the results remain inconclusive. The EFFECTS (Efficacy oF Fluoxetine – a randomisEd Controlled Trial in Stroke) reac...

    Authors: Erik Lundström, Eva Isaksson, Per Näsman, Per Wester, Björn Mårtensson, Bo Norrving, Håkan Wallén, Jörgen Borg, Martin Dennis, Gillian Mead, Graeme J. Hankey, Maree L. Hackett and Katharina S. Sunnerhagen

    Citation: Trials 2020 21:233

    Content type: Update

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    The original article was published in Trials 2015 16:369

  20. Pleural lavage is regularly performed before closing the chest wall in pulmonary surgeries to prevent pleural implantation of tumor cells and postoperative infection. However, scant data could be found in the ...

    Authors: Jian Zhou, Chengwu Liu, Shulei Man, Mengyuan Lyu, Hu Liao, Nan Chen, Yuhui Cheng and Lunxu Liu

    Citation: Trials 2020 21:232

    Content type: Study protocol

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  21. Adolescent pregnancy is a pressing public health issue globally, and particularly in low and middle-income countries. Depression occurring in the perinatal period is common among women and more so among adoles...

    Authors: Oye Gureje, Lola Kola, Bibilola D. Oladeji, Jibril Abdulmalik, Olatunde Ayinde, Phyllis Zelkowitz and Ian Bennett

    Citation: Trials 2020 21:231

    Content type: Study protocol

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  22. Adult participation in sport is associated with important positive psychosocial outcomes. Despite the multitude of benefits that have been linked to sport participation, adult participation rates in Canada rem...

    Authors: Stina J. Grant, Mark R. Beauchamp, Chris M. Blanchard, Valerie Carson and Ryan E. Rhodes

    Citation: Trials 2020 21:230

    Content type: Study protocol

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  23. It is difficult to achieve a balance among safety, efficacy, and cost for the clinical treatment of plaque psoriasis. The current treatment of psoriasis often involves comprehensive therapy such as topical pla...

    Authors: Meng Xing, Xiaoning Yan, Suqing Yang, Linge Li, Liping Gong, Hongxia Liu, Rong Xu, Jie Chen, Luo Ying, Yiding Zhao, Yuepeng An, Yang Liu, Gang Huang, Fei Guo, Qingfeng Yin, Ruiping Wang…

    Citation: Trials 2020 21:229

    Content type: Study protocol

    Published on:

  24. Automatic processes to approach smoking-related cues have been repeatedly linked to smoking status, intensity of smoking, and cigarette craving. Moreover, recent findings suggest that targeting those tendencie...

    Authors: Alla Machulska, Tanja Joan Eiler, Armin Grünewald, Rainer Brück, Katharina Jahn, Björn Niehaves, Heiko Ullrich and Tim Klucken

    Citation: Trials 2020 21:227

    Content type: Study protocol

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  25. Pelvic organ prolapse (POP) is a common health problem and has significant negative effects on a woman’s quality of life. The transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits ...

    Authors: Juan Chen, Jiajie Yu, Abraham Morse, Christian Fünfgeld, Kuanhui Huang, Jian Gong, Guangshi Tao, Binan Wang, Yuling Wang, Xiangyang Jiang, Gulina Ababaikeli, Peishu Liu, Hatiguli Nisier, Xiaowei Zhang, Ping Wang, Xin Sun…

    Citation: Trials 2020 21:226

    Content type: Study protocol

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  26. Emerging evidence has shown that vitamin D and magnesium have anti-inflammatory and anti-depressant effects. Dietary intake of magnesium is associated with reduced body mass index, waist circumference, body fa...

    Authors: Behnaz Abiri and Mohammadreza Vafa

    Citation: Trials 2020 21:225

    Content type: Study protocol

    Published on:

  27. Acute abdomen is a common disease in the emergency department (ED) and usually results in huge medical expenditure. To relieve abdominal pain effectively and reduce bed occupancy rate in emergency rooms, elect...

    Authors: Yuan Ya Chang, Chih Wen Chiu, Chia Yun Chen, Chin Fu Chang, Tsung Chieh Lee, Lun Chien Lo, Chia Ying Lee, Kai Chang, Po Wei Chen, Chang Ju Hsieh, Yu Jun Chang and Sung Yen Huang

    Citation: Trials 2020 21:224

    Content type: Study protocol

    Published on:

  28. Optimising hearing and vision function may be important in improving a range of outcomes for people living with dementia (PwD) and their companions. The SENSE-Cog cross-national randomised controlled trial (RC...

    Authors: Iracema Leroi, Christopher J. Armitage, Fidéline Collin, Eric Frison, Mark Hann, Emma Hooper, David Reeves, Zoe Simkin and Lucas Wolski

    Citation: Trials 2020 21:223

    Content type: Study protocol

    Published on:

  29. Osteoarthritis of the knee is a common condition that is expected to rise in the next two decades leading to an associated increase in total knee replacement (TKR) surgery. Although there is little debate rega...

    Authors: Celia Clarke, Valerie Pomeroy, Allan Clark, Graham Creelman, Nicola Hancock, Simon Horton, Anne Killett, Charles Mann, Estelle Payerne, Andoni Toms, Gareth Roberts, Toby Smith, Ann Marie Swart and Iain McNamara

    Citation: Trials 2020 21:222

    Content type: Study protocol

    Published on:

  30. An extreme and persistent dysbiosis occurs among critically ill patients, regardless of the heterogeneity of disease. Dysbiosis in critically ill patients may make them prone to hospital-acquired infections, s...

    Authors: Najmeh Seifi, Mohammad Safarian, Mohsen Nematy, Reza Rezvani, Majid Khadem-Rezaian and Alireza Sedaghat

    Citation: Trials 2020 21:221

    Content type: Study protocol

    Published on:

  31. Cambodia has made notable progress in the fight against tuberculosis (TB). However, these gains are impeded by a significant proportion of undiagnosed cases. To effectively reach people with TB, active case-fi...

    Authors: Alvin Kuo Jing Teo, Kiesha Prem, Konstantin Evdokimov, Chetra Ork, Sothearith Eng, Sovannary Tuot, Monyrath Chry, Tan Eang Mao, Li Yang Hsu and Siyan Yi

    Citation: Trials 2020 21:220

    Content type: Study protocol

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  32. Idiopathic membranous nephropathy (IMN) remains the leading cause of adult nephrotic syndrome. Immunosuppressive therapy with cyclophosphamide (CTX) is often successful in reducing proteinuria, but its use is ...

    Authors: Shasha Chen, Song Ren, Amanda Y. Wang, Hieu Tran, Zheng Li, Xiaoyun Cheng, Manli Liu, Guisen Li, Li Wang and Daqing Hong

    Citation: Trials 2020 21:219

    Content type: Study protocol

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  33. Total knee arthroplasty (TKA) is considered an effective treatment for pain relief and improved physical performances in end-stage knee osteoarthritis. However, several studies have reported less favorable out...

    Authors: Jesper Bie Larsen, Søren T. Skou, Lars Arendt-Nielsen, Ole Simonsen and Pascal Madeleine

    Citation: Trials 2020 21:218

    Content type: Study protocol

    Published on:

  34. Naturalistic developmental behavioural interventions (NDBI) have been shown to improve autism-specific symptoms in young children with Autism Spectrum Disorder (ASD). NDBI approaches, such as the ASD-specific ...

    Authors: Janina Kitzerow, Matthes Hackbusch, Katrin Jensen, Meinhard Kieser, Michele Noterdaeme, Ulrike Fröhlich, Regina Taurines, Julia Geißler, Nicole Wolff, Veit Roessner, Nico Bast, Karoline Teufel, Ziyon Kim and Christine M. Freitag

    Citation: Trials 2020 21:217

    Content type: Study protocol

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  35. Laparoscopy, by its minimally invasive nature, has revolutionized digestive and particularly colorectal surgery by decreasing post-operative pain, morbidity, and length of hospital stay. In this trial, we aim ...

    Authors: S. Celarier, S. Monziols, M. O. Francois, V. Assenat, P. Carles, M. Capdepont, C. Fleming, E. Rullier, G. Napolitano and Q. Denost

    Citation: Trials 2020 21:216

    Content type: Study protocol

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  36. Recruitment and retention in clinical trials remains an important challenge, particularly in the context of advanced disease. It is important to understand what affects retention to improve trial quality, mini...

    Authors: N. Lovell, S. N. Etkind, S. Bajwah, M. Maddocks and I. J. Higginson

    Citation: Trials 2020 21:215

    Content type: Research

    Published on:

  37. Approximately 40% of the newly diagnosed patients with advanced ovarian cancer are aged 70 years or older. Standard treatment for advanced disease consists of cytoreductive surgery and combination chemotherapy...

    Authors: Neeltje J. van Soolingen, Carolina H. Smorenburg, Marije E. Hamaker, Wim G. Groen, Valesca P. Retèl, Christianne A. R. Lok, Lonneke V. van de Poll-Franse and Johannes W. Trum

    Citation: Trials 2020 21:214

    Content type: Study protocol

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  38. While lay-health worker models for mental health care have proven to be effective in controlled trials, there is limited evidence on the effectiveness and scalability of these models in rural communities in lo...

    Authors: Kaustubh Joag, Jasmine Kalha, Deepa Pandit, Susmita Chatterjee, Sadhvi Krishnamoorthy, Laura Shields-Zeeman and Soumitra Pathare

    Citation: Trials 2020 21:212

    Content type: Study protocol

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  39. Muscle soreness after exercise, called delayed-onset muscle soreness (DOMS), may cause significant changes in muscle function and may increase the risk of sports injuries. Therefore, various therapeutic strate...

    Authors: Kyungsun Han, Ojin Kwon, So-Young Jung, In-hwa Park, Man-Suk Hwang, Sun-Young Park, Eui-Hyoung Hwang and Jun-Hwan Lee

    Citation: Trials 2020 21:211

    Content type: Study protocol

    Published on:

  40. The structures of the mesentery including adipose tissue, nerves, and lymphatics play an important role in the pathogenesis and disease progression of Crohn’s disease (CD). Conventional surgical resection for ...

    Authors: Yi Li, Helen Mohan, Nan Lan, Xiaojian Wu, Wei Zhou, Jianfeng Gong, Bo Shen, Luca Stocchi, J. Calvin Coffey and Weiming Zhu

    Citation: Trials 2020 21:210

    Content type: Study protocol

    Published on:

  41. Patients’ pre-operative health and physical function is known to influence their post-operative outcomes. In patients with knee osteoarthritis, pharmacological and non-pharmacological options are often not opt...

    Authors: A. Hamish R. W. Simpson, Anna Bell-Higgs, Philip G. Conaghan, Peter Craig, David F. Hamilton, Catherine Hankey, Catriona Keerie, Sarah R. Kingsbury, Elaine Kinsella, Anthony R. Leeds, John Norrie, Hemant G. Pandit, Hazel M. Ross, Sharon Anne Simpson and Chris Tuck

    Citation: Trials 2020 21:209

    Content type: Study protocol

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    The Correction to this article has been published in BMC Psychiatry 2020 20:132

  42. The Health Research Board-Trials Methodology Research Network (HRB-TMRN) celebrates International Clinical Trials Day with the help of the younger members of our community through the Network’s ‘Schools Teachi...

    Authors: Linda Biesty, Sandra Galvin, Elaine Finucane, Patricia Healy, Declan Devane and Tom Conway

    Citation: Trials 2020 21:208

    Content type: Research

    Published on:

  43. Thrice-weekly haemodialysis is the usual dose when starting renal replacement therapy; however, this schedule is no longer appropriate since it does not consider residual renal function. Several reports have s...

    Authors: M. Fernández Lucas, G. Ruíz-Roso, J. L. Merino, R. Sánchez, H. Bouarich, J. A. Herrero, A. Muriel, J. Zamora and A. Collado

    Citation: Trials 2020 21:206

    Content type: Study protocol

    Published on:

  44. Temporary fixation with an external fixator is used for numerous indications in orthopedic trauma surgery. It is unclear whether primary wound healing or secondary open-wound healing after removal of the exter...

    Authors: Franz Roth, Flavio Cagienard, Björn C. Link, Sandro Hodel, Dirk Lehnick, Reto Babst and Frank J. P. Beeres

    Citation: Trials 2020 21:205

    Content type: Study protocol

    Published on:

  45. The innervation of the shoulder-upper-extremity area is complicated and unclear. Regional anesthesia with a brachial plexus and cervical plexus block is probably inadequate for the proximal humeral surgery. Mi...

    Authors: Xiaofeng Wang, Hui Zhang, Zhenwei Xie, Qingfu Zhang, Wei Jiang and Junfeng Zhang

    Citation: Trials 2020 21:204

    Content type: Study protocol

    Published on:

  46. When physical activity contains training of at least three components such as balance, coordination and strength, among others, it is called multicomponent training. This type of training is recommended for im...

    Authors: Glaucio Carneiro Costa, João Carlos Ferrari Corrêa, Soraia Micaela Silva, Simone Dal Corso, Stefany Ferreira da Cruz, Micaelly de Souza Cunha, Paulo Henrique Leite Souza, Marcella Leiva Saldanha and Fernanda Ishida Corrêa

    Citation: Trials 2020 21:203

    Content type: Study protocol

    Published on:

  47. Multiple national expert panels have identified early detection of Alzheimer’s disease and related dementias (ADRD) as a national priority. However, the United States Preventive Services Task Force (USPSTF) do...

    Authors: Nicole R. Fowler, Katharine J. Head, Anthony J. Perkins, Sujuan Gao, Christopher M. Callahan, Tamilyn Bakas, Shelley D. Suarez and Malaz A. Boustani

    Citation: Trials 2020 21:202

    Content type: Study protocol

    Published on:

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