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  1. Nocebo effects (‘negative placebo’ effects) experienced by clinical trial participants can arise from an underlying condition or through communication about side effects in the participant information leaflets...

    Authors: Nigel Kirby, Victoria Shepherd, Jeremey Howick, Sophie Betteridge and Kerenza Hood

    Citation: Trials 2020 21:658

    Content type: Research

    Published on:

  2. Despite the importance of dairy proteins in modifying of metabolic abnormalities, no attention has been given to their effects on endocannabinoids.

    Authors: Fatemeh Haidari, Vahideh Aghamohammadi, Majid Mohammadshahi, Kambiz Ahmadi-Angali and Mohammad Asghari-Jafarabadi

    Citation: Trials 2020 21:657

    Content type: Research

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  3. To inform the design of a clinical trial of a targeted screening programme for relatives of individuals affected by thoracic aortic disease, we performed a consensus exercise as to the acceptability of screeni...

    Authors: R. G. Abbasciano, J. Barwell, R. Sayers, M. Bown, D. Milewicz, G. Cooper, G. Mariscalco, N. Wheeldon, C. Fowler, G. Owens and G. J. Murphy

    Citation: Trials 2020 21:656

    Content type: Research

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  4. It is estimated that 55 million adults will be 65 years and older in the USA by 2020. These older adults are at increased risk for injury and their recovery is multi-faceted. A collaborative care model may imp...

    Authors: Damaris Ortiz, Ashley D. Meagher, Heidi Lindroth, Emma Holler, Sujuan Gao, Babar Khan, Sue Lasiter, Malaz Boustani and Ben Zarzaur

    Citation: Trials 2020 21:655

    Content type: Study protocol

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  5. HIV disproportionately affects men who have sex with men (MSM) in the USA, and new infections continue to increase, particularly among African American (AA) and Hispanic/Latino (H/L) MSM. Rates of HIV testing ...

    Authors: Tyler B. Wray, Philip A. Chan, Jeffrey D. Klausner, Leandro A. Mena, James B. Brock, Erik M. Simpanen, Lori M. Ward and Stafylis Chrysovalantis

    Citation: Trials 2020 21:654

    Content type: Study protocol

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  6. Process evaluation addresses the implementation, mechanisms of impact, and context of participants in complex interventions. The STADPLAN study assesses the effects of conversations on advance care planning (A...

    Authors: Katharina Silies, Rieke Schnakenberg, Almuth Berg, Änne Kirchner, Henriette Langner, Juliane Köberlein-Neu, Gabriele Meyer, Falk Hoffmann and Sascha Köpke

    Citation: Trials 2020 21:653

    Content type: Study protocol

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  7. There is limited evidence that rituximab, a B cell depletion therapy, is an effective treatment for systemic lupus erythematosus (SLE). Data on the mechanisms of B cell depletion in SLE indicate that the combi...

    Authors: Patrick Muller, Kashfia Chowdhury, Caroline Gordon, Michael R. Ehrenstein and Caroline J. Doré

    Citation: Trials 2020 21:652

    Content type: Update

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  8. We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysi...

    Authors: Andrew Lawson, Justine Naylor, Rachelle Buchbinder, Rebecca Ivers, Zsolt Balogh, Paul Smith, Rajat Mittal, Wei Xuan, Kirsten Howard, Arezoo Vafa, Piers Yates, Bertram Rieger, Geoff Smith, Ilia Elkinson, Woosung Kim, Jai Sungaran…

    Citation: Trials 2020 21:651

    Content type: Update

    Published on:

  9. An amendment to this paper has been published and can be accessed via the original article.

    Authors: Ebaa Al Ozairi, Dalal Alsaeed, Dennis Taliping, Mohamad Jalali, Abeer El Samad, Anant Mashankar, Etab Taghadom, Nicola Guess, Jason M. R. Gill, Naveed Sattar, Cindy Gray, Paul Welsh and Stuart R. Gray

    Citation: Trials 2020 21:650

    Content type: Correction

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    The original article was published in Trials 2020 21:557

  10. Mild cognitive impairment is considered a precursor to dementia and significantly impacts upon quality of life. The prevalence of mild cognitive impairment is higher in the post-surgical cardiac population tha...

    Authors: Jacqueline M. S. Pengelly, Alistair G. Royse, Adam L. Bryant, Gavin P. Williams, Lynda J. Tivendale, Timothy J. Dettmann, David J. Canty, Colin F. Royse and Doa A. El-Ansary

    Citation: Trials 2020 21:649

    Content type: Study protocol

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  11. Objective 1: To determine if it is feasible to conduct an RCT of online Sudarshan Kriya Yoga (SKY) for frontline hospital and long-term care home staff under the constraints imposed by the COVID-19 pandemic and n...

    Authors: Ka Sing Paris Lai, Christine Watt, Emily Ionson, Imants Baruss, Cheryl Forchuk, Javeed Sukhera, Amer M. Burhan and Akshya Vasudev

    Citation: Trials 2020 21:648

    Content type: Letter

    Published on:

  12. Primary Objective: To determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily reduces microbiologically confirmed COVID-19 among front line health care workers at...

    Authors: Julie K. Wright, Darrell H. S. Tan, Sharon L. Walmsley, Jennifer Hulme, Erin O’Connor, Carolyn Snider, Ivy Cheng, Adrienne K. Chan, Bjug Borgundvaag, Shelley McLeod, Michael H. Gollob, Rosemarie J. Clarke, Linda Dresser, Fatima Haji, Tony Mazzulli, Samira Mubareka…

    Citation: Trials 2020 21:647

    Content type: Letter

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  13. To determine if lopinavir/ritonavir +/- hydroxychloroquine will reduce the proportion of participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-...

    Authors: Justin T. Denholm, Joshua Davis, David Paterson, Jason Roberts, Susan Morpeth, Thomas Snelling, Dominica Zentner, Megan Rees, Matthew O’Sullivan, David Price, Asha Bowen and Steven Y. C. Tong

    Citation: Trials 2020 21:646

    Content type: Letter

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  14. Delirium is an acute status of brain dysfunction that commonly occurs in patients who have undergone cardiac surgery, and increases morbidity and mortality. It is associated with risk factors, such as older ag...

    Authors: Hong-Bai Wang, Liang Zhang, Zhe Zhang, Su Yuan, Fu-Xia Yan and Qi-Peng Luo

    Citation: Trials 2020 21:645

    Content type: Study protocol

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  15. Despite evidence of a quite large beneficial effect of endovascular treatment (EVT) for ischemic stroke caused by anterior circulation large vessel occlusion, many patients do not recover even after complete r...

    Authors: Vicky Chalos, Rob A. van de Graaf, Bob Roozenbeek, Adriaan C. G. M. van Es, Heleen M. den Hertog, Julie Staals, Lukas van Dijk, Sjoerd F.M. Jenniskens, Robert J. van Oostenbrugge, Wim H. van Zwam, Yvo B.W.E.M. Roos, Charles B.L.M. Majoie, Hester F. Lingsma, Aad van der Lugt and Diederik W.J. Dippel

    Citation: Trials 2020 21:644

    Content type: Study protocol

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  16. The standard therapy for patients suffering from sensorineural hearing loss is cochlear implantation. The insertion of the electrode array into the cochlea, with potential mechanical trauma and the presence of...

    Authors: Verena Scheper, Melanie Schmidtheisler, Florian Lasch, Heiko von der Leyen, Armin Koch, Jana Schwieger, Andreas Büchner, Anke Lesinski-Schiedat and Thomas Lenarz

    Citation: Trials 2020 21:643

    Content type: Research

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  17. William James’ 1884 paper “What is an emotion?” has generated much recent interest in affective science regarding somatic contributions to emotion. Studies of interoception (“sensing the physiological conditio...

    Authors: Steven Davey, Elliot Bell, Jamin Halberstadt and Sunny Collings

    Citation: Trials 2020 21:642

    Content type: Study protocol

    Published on:

  18. An amendment to this paper has been published and can be accessed via the original article.

    Authors: Carmel M. McEniery, Marie Fisk, Karen Miles, Fotini Kaloyirou, Annette Hubsch, Jane Smith, Ian B. Wilkinson and Joseph Cheriyan

    Citation: Trials 2020 21:641

    Content type: Correction

    Published on:

    The original article was published in Trials 2020 21:604

  19. The application of neuroendoscopy in intraventricular hemorrhage (IVH) has attracted more and more attention in recent years. Studies have shown that the use of neuroendoscopy for IVH evacuation has advantages...

    Authors: Junhao Zhu, Chao Tang, Zixiang Cong, Jin Yang, Xiangming Cai, Yuxiu Liu and Chiyuan Ma

    Citation: Trials 2020 21:640

    Content type: Study protocol

    Published on:

  20. Primary Objective

    Authors: Keisha Smith, Amy Pace, Stephan Ortiz, Shamsah Kazani and Scott Rottinghaus

    Citation: Trials 2020 21:639

    Content type: Letter

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  21. Advances in peri-operative oncological treatment, surgery and peri-operative care have improved survival for patients with oesophagogastric cancers. Neoadjuvant cancer treatment (NCT) reduces physical fitness,...

    Authors: Roisin Tully, Lisa Loughney, Jarlath Bolger, Jan Sorensen, Oliver McAnena, Chris G. Collins, Paul A. Carroll, Mayilone Arumugasamy, Tomas J. Murphy and William B. Robb

    Citation: Trials 2020 21:638

    Content type: Study protocol

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  22. The proportion of older citizens is increasing worldwide. A well-known syndrome in old age is physical frailty which is associated with a greater risk of disabilities in activities of daily living, greater rel...

    Authors: Sussi F. Buhl, Anne Marie Beck, Britt Christensen and Paolo Caserotti

    Citation: Trials 2020 21:637

    Content type: Study protocol

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  23. Increasing physical activity (PA) is considered to be an important factor for the efficient management of chronic obstructive pulmonary disease (COPD). Successful methods required to achieve improvements in PA...

    Authors: Marc Spielmanns, Tobias Boeselt, Stephan Huber, Pawandeep Kaur Bollinger, Bernhard Ulm, Anna-Maria Peckaka-Egli, Inga Jarosch, Tessa Schneeberger, Sabine Schoendorf, Rainer Gloeckl and A. Rembert Koczulla

    Citation: Trials 2020 21:636

    Content type: Study protocol

    Published on:

  24. The aim of this trial is to identify the effect of ambulatory treatment in early COVID-19 disease with hydroxychloroquine on the rate of hospitalization or death in older patients above the age of 64.

    Authors: Siri Göpel, Wolfgang Bethge, Peter Martus, Florian Kreth, Thomas Iftner, Stefanie Joos, Stefanie Döbele, Benjamin Mordmüller, Peter Kremsner, Thomas Ettrich, Thomas Seufferlein, Michael Bitzer and Nisar Malek

    Citation: Trials 2020 21:635

    Content type: Letter

    Published on:

  25. The prevalence of pneumonia complicating stroke in acute phase has a poor prognosis and higher risk for death. Oral opportunistic pathogens have been reported to be associated with pneumonia among people with ...

    Authors: Juncang Wu, Yuanchang Dai, Edward C. M. Lo, Yinliang Qi, Ya Zhang, Quan-li Li and Ruoxi Dai

    Citation: Trials 2020 21:634

    Content type: Study protocol

    Published on:

  26. Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance with onset or first recognition during pregnancy, which is characterized by an increased insulin resistance. Gestational diabetes me...

    Authors: George Asimakopoulos, Vasilios Pergialiotis, Eleni Anastasiou, Panagiotis Antsaklis, Mariana Theodora, Evangelia Vogiatzi, Aggela Kallergi, Michael Sindos, Dimitrios Loutradis and George Daskalakis

    Citation: Trials 2020 21:633

    Content type: Study protocol

    Published on:

  27. The aim of this study is to explore the effectiveness and safety of oral corticosteroids (prednisone) in the treatment of early stage SARS-Cov-2 pneumonia in patients who do not yet meet hospital admission cri...

    Authors: Miriam Saiz-Rodríguez, Teresa Peña, Lourdes Lázaro, Ángel González, Andrés Martínez, José A. Cordero, Juan T. Vicente, Fernando Richard, María Jesús Coma, Martín de Frutos, Jorge Labrador and Ana Pueyo

    Citation: Trials 2020 21:632

    Content type: Letter

    Published on:

  28. Novel coronavirus SARS-CoV-2 is known to be susceptible in vitro to exposure to hydroxychloroquine and its effect has been found to be potentiated by azithromycin. We hypothesise that early administration of h...

    Authors: František Duška, Petr Waldauf, Milada Halačová, Václav Zvoníček, Jakub Bala, Martin Balík, Jan Beneš, Olga Klementová, Irena Kozáková, Viktor Kubricht, Anne Le Roy, Tomáš Vymazal, Veronika Řehořová and Vladimír Černý

    Citation: Trials 2020 21:631

    Content type: Study protocol

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  29. Postherpetic neuralgia (PHN) is one of the most common types of chronic neuropathic pain, which seriously affects quality of the life because of pain severity and poor response to the currently available treat...

    Authors: Lu Chen, Ruihao Zhou, Fuguo Sun, Yan Weng, Ling Ye and Pingliang Yang

    Citation: Trials 2020 21:630

    Content type: Study protocol

    Published on:

  30. The utility of patient screening logs and their impact on improving trial recruitment rates are unclear. We conducted a retrospective exploratory analysis of screening data collected within a multicentre rando...

    Authors: Rebecca Lewis, Rachel Todd, Michelle Newton, Robert J. Jones, Caroline Wilson, Jenny L. Donovan, Richard T. Bryan, Alison Birtle and Emma Hall

    Citation: Trials 2020 21:629

    Content type: Research

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  31. Current guidelines recommend the prescription of immune-enriched oral nutritional supplements for malnourished patients before major gastrointestinal surgery. However, the benefit of preoperative immunonutriti...

    Authors: Soo Young Lee, Seung-Seop Yeom, Chang Hyun Kim and Hyeong Rok Kim

    Citation: Trials 2020 21:628

    Content type: Study protocol

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  32. With a survival rate of 6 to 11%, out-of-hospital cardiac arrest (OHCA) remains a healthcare challenge with room for improvement in morbidity and mortality. The guidelines emphasize the highest possible qualit...

    Authors: Clément Buléon, Jean-Jacques Parienti, Elodie Morilland-Lecoq, Laurent Halbout, Eric Cesaréo, Pierre-Yves Dubien, Benoit Jardel, Christophe Boyer, Kévin Husson, Florian Andriamirado, Xavier Benet, Emmanuel Morel-Marechal, Antoine Aubrion, Catalin Muntean, Erwan Dupire, Eric Roupie…

    Citation: Trials 2020 21:627

    Content type: Study protocol

    Published on:

  33. To determine if a specific immunomodulatory intervention reduces progression of COVID-19-related disease to organ failure or death, compared to standard of care (SoC).

    Authors: Spoorthy Kulkarni, Marie Fisk, Michalis Kostapanos, Edward Banham-Hall, Simon Bond, Elena Hernan-Sancho, Sam Norton, Joseph Cheriyan, Andrew Cope, James Galloway, Frances Hall, David Jayne and Ian B. Wilkinson

    Citation: Trials 2020 21:626

    Content type: Letter

    Published on:

  34. Autoimmune encephalitis is a new spectrum of autoimmune disorders of the central nervous system (CNS), which are characterized by pathogenic autoantibodies against neuronal surface antigens. Clinical presentat...

    Authors: Jonathan Wickel, Ha-Yeun Chung, Stephanie Platzer, Thomas Lehmann, Harald Prüss, Frank Leypoldt, Albrecht Günther, André Scherag and Christian Geis

    Citation: Trials 2020 21:625

    Content type: Study protocol

    Published on:

  35. Native tissue cystocele repair has been the cornerstone of prolapse surgery, especially since the learned societies warned clinicians and patients about serious mesh-related complications. Surgical techniques ...

    Authors: A. Lacorre, F. Vidal, S. Campagne-Loiseau, B. Marin, Y. Aubard, F. Siegerth, C. Mesnard, E. Chantalat, C. Hocke and T. Gauthier

    Citation: Trials 2020 21:624

    Content type: Study protocol

    Published on:

  36. The World Health Organization initiated test, treat, and track (T3) malaria strategy to support malaria-endemic countries in their efforts to achieve universal coverage with diagnostic testing, antimalarial tr...

    Authors: Olajoju Temidayo Soniran, Benjamin Abuaku and Collins Stephen Ahorlu

    Citation: Trials 2020 21:623

    Content type: Study protocol

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  37. The outbreak of COVID-19 (caused by SARS-Cov-2) is very serious, and no effective antiviral treatment has yet been confirmed. The adage “old drug, new trick” in this context may suggest the important therapeut...

    Authors: Xi Liu, Huili Chen, Yuqi Shang, Hongqiong Zhu, Gongqi Chen, Yuanli Chen, Shaoxuan Liu, Yaoyong Zhou, Mingxing Huang, Zhongsi Hong and Jinyu Xia

    Citation: Trials 2020 21:622

    Content type: Study protocol

    Published on:

  38. Blood from younger individuals has been shown to improve physiological function in recipients in laboratory research, and many proteins from human peripheral blood show antisenescence capabilities. Thus, resea...

    Authors: Xianfei Zeng, Yan Liao, Xiaoshuang Wu, Jinmei Xu, Chenxing Da, Zhijun Tan, Fan Feng, Wen Yin, Dongjian Wang and Xingbin Hu

    Citation: Trials 2020 21:621

    Content type: Study protocol

    Published on:

  39. Clinicians, patients, and policy-makers rely on published evidence from clinical trials to help inform decision-making. A lack of complete and transparent reporting of the investigated trial outcomes limits re...

    Authors: Nancy J. Butcher, Emma J. Mew, Andrea Monsour, An-Wen Chan, David Moher and Martin Offringa

    Citation: Trials 2020 21:620

    Content type: Review

    Published on:

  40. In the Netherlands, midwives are required to use the ‘V-MIS’ (Minimal Intervention Strategy for Midwives) smoking cessation counselling protocol to help pregnant women quit smoking. This counselling protocol i...

    Authors: Jeroen Bommelé, Linda Springvloet, Naïma Abouri, Karianne Djoyoadhiningrat-Hol, Margriet van Laar and Matthijs Blankers

    Citation: Trials 2020 21:619

    Content type: Study protocol

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  41. Obese patients undergoing general anesthesia and mechanical ventilation during laparoscopic abdominal surgery commonly have a higher incidence of postoperative pulmonary complications (PPCs), due to factors su...

    Authors: Chen Zhu, Jing-Wen Yao, Li-Xin An, Ya-Fan Bai and Wen-Jing Li

    Citation: Trials 2020 21:618

    Content type: Study protocol

    Published on:

  42. Postoperative gastrointestinal (GI) dysfunction (PGD) is a common problem after abdominal surgery. PGD can increase the length of hospital stay and may lead to serious complications. Acupuncture and moxibustio...

    Authors: Ya-Fan Bai, Chao Gao, Wen-Jing Li, Yi Du and Li-Xin An

    Citation: Trials 2020 21:617

    Content type: Study protocol

    Published on:

  43. Elevated cholesterol levels and systemic inflammation are considered relevant risk factors for cardiovascular disease (CVD) development and progression. Increasing evidence suggests that cholesterol-lowering a...

    Authors: Anna Rita Bonfigli, Olga Protic, Fabiola Olivieri, Alberto Montesanto, Gelsomina Malatesta, Raffaele Di Pillo and Roberto Antonicelli

    Citation: Trials 2020 21:616

    Content type: Study protocol

    Published on:

  44. Chronic musculoskeletal pain (MSP) affects more than 40% of adults aged 50 years and older and is the leading cause of disability in the USA. Older adults with chronic MSP are at risk for analgesic-related sid...

    Authors: Timothy F. Platts-Mills, Samuel A. McLean, Morris Weinberger, Sally C. Stearns, Montika Bush, Brittni B. Teresi, Karen Hurka-Richardson, Kurt Kroenke, Robert D. Kerns, Mark A. Weaver and Francis J. Keefe

    Citation: Trials 2020 21:615

    Content type: Study protocol

    Published on:

  45. This study will evaluate the main hypothesis that supplementation with vitamins A, B, C, D, and E significantly improves the severity and mortality rate in ICU patients with COVID-19.

    Authors: Mohammad Taghi Beigmohammadi, Sama Bitarafan, Azin Hoseindokht, Alireza Abdollahi, Laya Amoozadeh, Maedeh Mahmoodi Ali Abadi and Morteza Foroumandi

    Citation: Trials 2020 21:614

    Content type: Study protocol

    Published on:

  46. In a randomized crossover trial, each participant is randomized to a sequence of treatments and treatment effect is estimated based on within-individual difference because each participant serves as his/her ow...

    Authors: Lijuan Zeng, Riaz Qureshi, Shilpa Viswanathan, Lea Drye and Tianjing Li

    Citation: Trials 2020 21:613

    Content type: Methodology

    Published on:

  47. Cancer-related fatigue (CRF) is the most taxing symptom for many breast cancer patients during and after therapy. In patients with metastatic disease, the prevalence of CRF exceeds 75%. Currently, there is no ...

    Authors: Delphine Meier-Girard, Karin Ribi, Gisa Gerstenberg, Thomas Ruhstaller and Ursula Wolf

    Citation: Trials 2020 21:612

    Content type: Study protocol

    Published on:

  48. Despite improvements in medical care, patients with advanced cancer still experience substantial symptom distress. There is increasing interest in the use of medicinal cannabinoids but little high-quality evid...

    Authors: Janet Hardy, Alison Haywood, Gauri Gogna, Jennifer Martin, Patsy Yates, Ristan Greer and Phillip Good

    Citation: Trials 2020 21:611

    Content type: Study protocol

    Published on:

  49. As there is no treatment for COVID-19 with a proven mortality benefit at this moment in the pandemic, supportive management including mechanical ventilation is the core management in an intensive care unit (IC...

    Authors: Atsushi Kawaguchi, Gabrielle Bernier, Jacques Lacroix, Saly El Salti, Matthew P. Cheng, Todd C. Lee, Kosar Khwaja and Philippe Jouvet

    Citation: Trials 2020 21:610

    Content type: Letter

    Published on:

  50. To evaluate the therapeutic effects of ultra-short-wave diathermy (SWD) on COVID-19 pneumonia. The hypothesis is that SWD may minimise pneumonic inflammation and shorten the duration of the time to positive-to...

    Authors: Mohammad Nasb, Zulfiqar Ali Sayed Shah, Liangjiang Huang, Qian Li and Hong Chen

    Citation: Trials 2020 21:609

    Content type: Letter

    Published on:

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