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  1. Approximately 60% of people with multiple sclerosis (PwMS) suffer from upper limb dysfunction. Our primary goal is to implement a single-blind, randomized control trial (RCT) designed to compare the effectiven...

    Authors: Alon Kalron, Anat Achiron, Massimiliano Pau and Eleonora Cocco

    Citation: Trials 2020 21:713

    Content type: Study protocol

    Published on:

  2. In cluster randomized crossover (CRXO) trials, groups of participants (i.e., clusters) are randomly allocated to receive a sequence of interventions over time (i.e., cluster periods). CRXO trials are becoming ...

    Authors: Sheila Sprague, Taryn Scott, Shannon Dodds, David Pogorzelski, Paula McKay, Anthony D. Harris, Amber Wood, Lehana Thabane, Mohit Bhandari, Samir Mehta, Greg Gaski, Christina Boulton, Francesc Marcano-Fernández, Ernesto Guerra-Farfán, Joan Hebden, Lyndsay M. O’Hara…

    Citation: Trials 2020 21:712

    Content type: Methodology

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  3. A core outcome set (COS) represents the agreed minimum set of domains and measurement instruments that should be measured and reported in any clinical trial for a given condition. In BMS randomized controlled ...

    Authors: B. Carey, A. M. Farag, C. Nasri-Heir, G. D. Klasser, A. Ariyawardana, M. Chmieliauskaite, A. Sardella, C. R. Carlson, C. S. Miller, L. Mejia, F. E. O’Neill and R. Albuquerque

    Citation: Trials 2020 21:711

    Content type: Study protocol

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  4. Resident-to-resident elder mistreatment (R-REM) is defined as negative and aggressive physical, sexual, or verbal interactions between (long-term care) residents that in a community setting would likely be con...

    Authors: Jeanne A. Teresi, Stephanie Silver, Mildred Ramirez, Jian Kong, Joseph P. Eimicke, Gabriel D. Boratgis, Rhoda Meador, Leslie Schultz, Mark S. Lachs and Karl A. Pillemer

    Citation: Trials 2020 21:710

    Content type: Study protocol

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  5. Recently, we demonstrated that the Montreal Museum of Fine Arts’ (MMFA) participatory art-based activity, known as “Thursdays at the Museum,” improved the well-being, quality of life, and physical health (i.e....

    Authors: Olivier Beauchet, Liam Cooper-Brown, Yoko Hayashi, Kevin Galery, Christine Vilcocq and Thomas Bastien

    Citation: Trials 2020 21:709

    Content type: Study protocol

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  6. Nucleos(t)ide analogues (NAs) are the first-line option against chronic hepatitis B (CHB). NAs produce potent suppression of viral replication with a small chance of HBsAg seroclearance and a high risk of viro...

    Authors: Xiaoke Li, Ludan Zhang, Mei Qiu, Yi Huang, Huanming Xiao, Bingjiu Lu, Yuyong Jiang, Fuli Long, Hui Lin, Jinyu He, Qikai Wu, Mingxiang Zhang, Li Wang, Xiaoning Zhu, Man Gong, Xuehua Sun…

    Citation: Trials 2020 21:708

    Content type: Study protocol

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

    Authors: Sarah Prentice, Emily L. Webb, Hazel M. Dockrell, Pontiano Kaleebu, Alison M. Elliott and Stephen Cose

    Citation: Trials 2020 21:707

    Content type: Correction

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    The original article was published in Trials 2015 16:149

  8. Social media represent cost-effective platforms to advance the dissemination and uptake of health research to improve population health. However, there is limited evidence available to support researchers over...

    Authors: Audrée-Anne Dumas, Simone Lemieux, Annie Lapointe, Véronique Provencher, Julie Robitaille and Sophie Desroches

    Citation: Trials 2020 21:706

    Content type: Research

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  9. Total knee arthroplasty (TKA) is a gold standard for patients with terminal term gonarthrosis for reducing pain, correcting deformities, and regaining stability. However, post-TKA muscle strength recovery is o...

    Authors: Hui Xu, Bingxin Kang, Yulin Li, Jun Xie, Songtao Sun, Sheng Zhong, Chenxin Gao, Xirui Xu, Chi Zhao, Guowei Qiu and Lianbo Xiao

    Citation: Trials 2020 21:705

    Content type: Study protocol

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  10. The primary aim of the present study is to examine the efficacy of an online intervention for poor sleep in the context of an ongoing stressful major life event, by assessing if this intervention can reduce in...

    Authors: Greg J. Elder, Pamela Alfonso-Miller, William C. M. Atkinson, Nayantara Santhi and Jason G. Ellis

    Citation: Trials 2020 21:704

    Content type: Letter

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  11. To investigate the potential efficacy of Nigella sativa (NS) oil supplementation on the outcomes of patients with mild Coronavirus Disease 2019 (COVID-19).

    Authors: Abdulrahman E. Koshak, Emad A. Koshak, Abdullah F. Mobeireek, Mazen A. Badawi, Siraj O. Wali, Husam M. Malibary, Ali F. Atwah, Meshari M. Alhamdan, Reem A. Almalki and Tariq A. Madani

    Citation: Trials 2020 21:703

    Content type: Letter

    Published on:

  12. To evaluate the effectiveness of Hydroxychloroquine Phosphate/Sulfate (200 mg orally 8 hourly thrice a day for 5 days), versus oseltamivir (75 mg orally twice a day for 5 days), and versus Azithromycin (500 mg or...

    Authors: Javed Akram, Shehnoor Azhar, Muhammad Shahzad, Waqas Latif and Khalid Saeed Khan

    Citation: Trials 2020 21:702

    Content type: Letter

    Published on:

  13. Acute herpes zoster (AHZ) is a common skin disease caused by invasion of the varicella zoster virus into the ganglia and skin, and the severe pain is the most complaint, which can seriously disturb the normal ...

    Authors: Ying Zhang, Zuohui Liang, Shihua Li, Ling Yang, Taipin Guo, Yan Xu, Juanjuan Yang, Qiannan Xu, Qing Zhang, Jian Zhao, Cailian Li and Xiuhong Liu

    Citation: Trials 2020 21:701

    Content type: Study protocol

    Published on:

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

    Authors: Shuanglan Lin, Lily Dongxia Xiao and Diane Chamberlain

    Citation: Trials 2020 21:700

    Content type: Correction

    Published on:

    The original article was published in Trials 2020 21:240

  15. • Primary objective: to evaluate the effect of intravenous melatonin (IVM) on mortality in adult patients admitted to the intensive care unit (ICU) with COVID-19.

    Authors: Miguel Rodríguez-Rubio, Juan Carlos Figueira, Darío Acuña-Castroviejo, Alberto M. Borobia, Germaine Escames and Pedro de la Oliva

    Citation: Trials 2020 21:699

    Content type: Letter

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  16. Irritable bowel syndrome (IBS) is one of the most frequent and recurrent gastrointestinal diseases. However, up to now, no pharmacological agent has been approved to treat IBS. Emerging evidence showed that in...

    Authors: Mahsa Miryan, Pezhman Alavinejad, Mohammadreza Abbaspour, Davood Soleimani and Alireza Ostadrahimi

    Citation: Trials 2020 21:698

    Content type: Study protocol

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  18. While the evolution of technology provides new opportunities to manage chronic refractory pain using different waveform modalities of spinal cord stimulation in failed back surgery syndrome (FBSS), there is no...

    Authors: Maxime Billot, Nicolas Naiditch, Claire Brandet, Bertille Lorgeoux, Sandrine Baron, Amine Ounajim, Manuel Roulaud, Aline Roy-Moreau, Géraldine de Montgazon, Elodie Charrier, Lorraine Misbert, Benjamin Maillard, Tanguy Vendeuvre and Philippe Rigoard

    Citation: Trials 2020 21:696

    Content type: Study protocol

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  19. Depression is a highly prevalent condition in the elderly, with a vast impact on quality of life, life expectancy, and medical outcomes. Selective serotonin reuptake inhibitors (SSRIs) are the most commonly pr...

    Authors: Giovanni Ostuzzi, Chiara Gastaldon, Angelo Barbato, Barbara D’Avanzo, Mauro Tettamanti, Igor Monti, Andrea Aguglia, Eugenio Aguglia, Maria Chiara Alessi, Mario Amore, Francesco Bartoli, Massimo Biondi, Paola Bortolaso, Camilla Callegari, Giuseppe Carrà, Rosangela Caruso…

    Citation: Trials 2020 21:695

    Content type: Study protocol

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  20. Participants in clinical research studies often do not reflect the populations for which healthcare interventions are needed or will be used. Enhancing representation of under-served groups in clinical researc...

    Authors: Miles D. Witham, Eleanor Anderson, Camille Carroll, Paul M. Dark, Kim Down, Alistair S. Hall, Joanna Knee, Rebecca H. Maier, Gail A. Mountain, Gary Nestor, Laurie Oliva, Sarah R. Prowse, Amanda Tortice, James Wason and Lynn Rochester

    Citation: Trials 2020 21:694

    Content type: Research

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  21. Approximately 30 to 50% of women are unable to correctly perform pelvic floor muscle (PFM) contractions. For women to benefit from a pelvic floor muscle training (PFMT) programme for stress urinary incontinenc...

    Authors: Letícia de Azevedo Ferreira, Fátima Faní Fitz, Márcia Maria Gimenez, Mayanni Magda Pereira Matias, Maria Augusta Tezelli Bortolini and Rodrigo Aquino Castro

    Citation: Trials 2020 21:693

    Content type: Study protocol

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  22. Harmful alcohol use is a leading cause of global disability and death. However, increased detection and brief intervention capacity of more severe alcohol use disorders has not been accompanied by increased av...

    Authors: Nicolas A. Barticevic, Fernando Poblete, Soledad M. Zuzulich, Victoria Rodriguez and Laura Bradshaw

    Citation: Trials 2020 21:692

    Content type: Study protocol

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  23. Stage 1: To evaluate the safety and efficacy of candidate agents as add-on therapies to standard of care (SoC) in patients hospitalised with COVID-19 in a screening stage.

    Authors: Tom Wilkinson, Rupert Dixon, Clive Page, Miles Carroll, Gareth Griffiths, Ling-Pei Ho, Anthony De Soyza, Timothy Felton, Keir E. Lewis, Karen Phekoo, James D. Chalmers, Anthony Gordon, Lorcan McGarvey, Jillian Doherty, Robert C. Read, Manu Shankar-Hari…

    Citation: Trials 2020 21:691

    Content type: Letter

    Published on:

  24. To determine if a specific intervention reduces the composite of progression of patients with COVID-19-related disease to organ failure or death as measured by time to incidence of any one of the following: de...

    Authors: Ing Ni Lu, Spoorthy Kulkarni, Marie Fisk, Michalis Kostapanos, Edward Banham-Hall, Sonakshi Kadyan, Simon Bond, Sam Norton, Andrew Cope, James Galloway, Frances Hall, David Jayne, Ian B. Wilkinson and Joseph Cheriyan

    Citation: Trials 2020 21:690

    Content type: Letter

    Published on:

  25. Hydroxychloroquine has shown to have antiviral activity in vitro against coronaviruses, specifically SARS-CoV-2. It is believed to block virus infection by increasing endosomal pH required for virus cell fusion a...

    Authors: Oriana Nanni, Pierluigi Viale, Bernadette Vertogen, Claudia Lilli, Chiara Zingaretti, Caterina Donati, Carla Masini, Manuela Monti, Patrizia Serra, Roberto Vespignani, Veruska Grossi, Annibale Biggeri, Emanuela Scarpi, Francesca Galardi, Lucia Bertoni, Americo Colamartini…

    Citation: Trials 2020 21:689

    Content type: Study protocol

    Published on:

  26. The aim of this study is to assess the efficacy of the use of pre-exposure prophylaxis (PrEP) with hydroxychloroquine against placebo in healthcare workers with high risk of severe acute respiratory syndrome c...

    Authors: Berta Grau-Pujol, Daniel Camprubí, Helena Marti-Soler, Marc Fernández-Pardos, Caterina Guinovart and Jose Muñoz

    Citation: Trials 2020 21:688

    Content type: Letter

    Published on:

  27. The trial objective is to determine if Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) is clinically effective compared to standard oxygen therapy in patients with confirmed or susp...

    Authors: Gavin D. Perkins, Keith Couper, Bronwen Connolly, J. Kenneth Baillie, Judy M. Bradley, Paul Dark, Anthony De Soyza, Ellen Gorman, Alasdair Gray, Louisa Hamilton, Nicholas Hart, Chen Ji, Ranjit Lall, Nicola McGowan, Scott Regan, Anita K. Simonds…

    Citation: Trials 2020 21:687

    Content type: Letter

    Published on:

  28. Allergic rhinitis (AR) in children is a major respiratory inflammatory disease with a high incidence that is increasing yearly. In China, 54.93% of children with asthma have AR, which often requires synchronou...

    Authors: Ming Chen, YuFen Wu, Shuhua Yuan, Jiande Chen, Luanluan Li, Jinhong Wu, Jing Zhang and Yong Yin

    Citation: Trials 2020 21:686

    Content type: Study protocol

    Published on:

  29. Traumatic brain injury (TBI) is the most common trauma worldwide and is a leading cause of injury-related death and disability. Inflammation is initiated as a result of the TBI, which is in association with se...

    Authors: Seyed Mostafa Arabi, Alireza Sedaghat, Mohammad Reza Ehsaei, Mohammad Safarian, Golnaz Ranjbar, Hamid Rezaee, Reza Rezvani, Hamed Tabesh and Abdolreza Norouzy

    Citation: Trials 2020 21:685

    Content type: Study protocol

    Published on:

  30. Bronchial asthma is one of the most common inflammatory airway disorders. As one of the main non-drug therapies, the Sanfu herbal patch (SHP) has been widely used to treat bronchial asthma, although the eviden...

    Authors: Xiaoyan Xie, Danghan Xu, Lixing Zhuang, Hui Liu, Sui Tan, Yanqing Lu, Meiyi Su, Jie Chen, Haihua Pan, Lu Lu, Yiming Xu, Muxi Liao, Zhanqiong Xu and Jun He

    Citation: Trials 2020 21:684

    Content type: Study protocol

    Published on:

  31. Working memory deficit is one of the most critical complex cognitive impairments in schizophrenia. Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy, but not still unsatisfac...

    Authors: Jiaqi Song, Dan Liu, Meng Zhang, Huiqiu Wang and Shuping Tan

    Citation: Trials 2020 21:683

    Content type: Study protocol

    Published on:

  32. Nonspecific chronic neck pain is a fairly common disorder that causes a great impact, and it is greatly influenced by psychosocial factors. Among a number of treatment modalities described for its management, ...

    Authors: Carlos Bernal-Utrera, Juan Jose Gonzalez-Gerez, Ernesto Anarte-Lazo and Cleofas Rodriguez-Blanco

    Citation: Trials 2020 21:682

    Content type: Research

    Published on:

  33. Early treatment with tranexamic acid may reduce deaths after traumatic brain injury (TBI). In mild and moderate TBI, there is a time to treatment interaction, with early treatment being most beneficial. Time t...

    Authors: Raoul Mansukhani, Lauren Frimley, Haleema Shakur-Still, Linda Sharples and Ian Roberts

    Citation: Trials 2020 21:681

    Content type: Research

    Published on:

  34. An effective drug to treat cryptosporidial diarrhea in HIV-infected individuals is a global health priority. Promising drugs need to be evaluated in endemic areas which may be challenged by both lack of resour...

    Authors: Neema Toto, Elaine Douglas, Markus Gmeiner, Lynn K. Barrett, Robert Lindblad, Lumbani Makhaza, Wilfred Nedi, Jacob Phulusa, Gerald V. Quinnan, Leigh A. Sawyer, Herbert Thole, Wesley C. Van Voorhis and Pui-Ying Iroh Tam

    Citation: Trials 2020 21:680

    Content type: Methodology

    Published on:

  35. Degenerative lumbar spinal stenosis (DLSS) is a common condition secondary to degenerative changes. Acupuncture may be effective for treating DLSS. However, there is a lack of sufficient evidence showing the e...

    Authors: Jing Zhou, Sixing Liu, Yuanjie Sun, Weiming Wang and Zhishun Liu

    Citation: Trials 2020 21:679

    Content type: Study protocol

    Published on:

  36. Neoadjuvant chemoradiotherapy followed by surgery is the mainstay treatment for locally advanced rectal cancer, leading to significant decrease in tumor size (downsizing) and a shift towards earlier disease st...

    Authors: Igor Monsellato, Elisabetta Garibaldi, Elisa Cassinotti, Ludovica Baldari, Luigi Boni, Ugo Elmore, Roberto Delpini, Riccardo Rosati, Roberto Perinotti, Filippo Alongi, Elisa Bertocchi, Stefania Gori, Giacomo Ruffo, Graziano Pernazza, Fabio Pulighe, Carlo De Nisco…

    Citation: Trials 2020 21:678

    Content type: Study protocol

    Published on:

  37. Guideline-based medical care has been identified to improve outcomes in stroke. However, data acquisition and medical quality management during hospital stay still need to be improved in China. We have develop...

    Authors: Yi Chen, Wansi Zhong, Xiaoxian Gong, Haitao Hu, Shenqiang Yan, Xuting Zhang, Zhicai Chen, Ying Zhou and Min Lou

    Citation: Trials 2020 21:677

    Content type: Study protocol

    Published on:

  38. Approximately 8–15% of patients undergoing bariatric surgery develop symptomatic gallstone disease within 24 months after surgery. Ursodeoxycholic acid (UDCA) seems to effectively prevent the formation of gall...

    Authors: Sylke Haal, Maimoena S. S. Guman, L. Maurits de Brauw, Ruben N. van Veen, Ruben Schouten, Paul Fockens, Victor E. A. Gerdes, Marcel G. W. Dijkgraaf and Rogier P. Voermans

    Citation: Trials 2020 21:676

    Content type: Update

    Published on:

    The Study protocol to this article has been published in BMC Gastroenterology 2017 17:164

  40. Process evaluation can illuminate barriers and facilitators to intervention implementation as well as the drivers of intervention outcomes. However, few obesity intervention studies have documented process eva...

    Authors: Jacob P. Beckerman-Hsu, Alyssa Aftosmes-Tobio, Adam Gavarkovs, Nicole Kitos, Roger Figueroa, Z. Begum Kalyoncu, Kindra Lansburg, Xinting Yu, Crystal Kazik, Adrienne Vigilante, Jessie Leonard, Merieka Torrico, Janine M. Jurkowski and Kirsten K. Davison

    Citation: Trials 2020 21:674

    Content type: Study protocol

    Published on:

  41. In China, psychodynamic psychotherapies are widely used as a treatment for depression. However, very few efficacy studies of psychodynamic therapies have been conducted with the Chinese population. This paper ...

    Authors: Lanlan Wang, Qian Wang, Wenhui Jiang, Jianfeng Luo, Jun Tong, Xiaosi Li, Fang Fang, Hongyan Wang, Wenqing Zhao, Diana Koszycki and Jianyin Qiu

    Citation: Trials 2020 21:673

    Content type: Study protocol

    Published on:

  42. Patients living in rural areas experience a variety of unmet needs that result in healthcare disparities. The triple threat of rural geography, racial inequities, and older age hinders access to high-quality p...

    Authors: Kristen Allen Watts, Shena Gazaway, Emily Malone, Ronit Elk, Rodney Tucker, Susan McCammon, Michele Goldhagen, Jacob Graham, Veronica Tassin, Joshua Hauser, Sidney Rhoades, Marjorie Kagawa-Singer, Eric Wallace, James McElligott, Richard Kennedy and Marie Bakitas

    Citation: Trials 2020 21:672

    Content type: Study protocol

    Published on:

  43. An estimand defines the target of estimation for a clinical trial through specification of the treatment, target population, variable, population-level summary and of the strategies for intercurrent events. A ...

    Authors: M. Mitroiu, K. Oude Rengerink, S. Teerenstra, F. Pétavy and K. C. B. Roes

    Citation: Trials 2020 21:671

    Content type: Review

    Published on:

  44. Treatment fidelity, defined as ensuring that the recipient receives the intended intervention, is a critical component for accurate estimation of treatment efficacy. Ensuring fidelity and protocol adherence in...

    Authors: Roberta W. Scherer, Sue Ann Erdman, Susan Gold and Craig Formby

    Citation: Trials 2020 21:670

    Content type: Methodology

    Published on:

  45. Idiopathic sudden sensorineural hearing loss (ISSNHL) is a rapid-onset sensorineural hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction has been considered as a...

    Authors: Weiming Hao, Liping Zhao, Huiqian Yu and Huawei Li

    Citation: Trials 2020 21:669

    Content type: Study protocol

    Published on:

  46. In sequential and adaptive trials, the delay that happens after the trial is stopped, by a predetermined stopping criterion, takes the name of overrunning. Overrunning consists of extra data, collected by inve...

    Authors: Ileana Baldi, Danila Azzolina, Nicola Soriani, Beatrice Barbetta, Paola Vaghi, Giampaolo Giacovelli, Paola Berchialla and Dario Gregori

    Citation: Trials 2020 21:668

    Content type: Methodology

    Published on:

  47. Neurogenic claudication is a common spinal condition affecting older adults that has a major effect on mobility and implicitly independence. The effectiveness of conservative interventions in this population i...

    Authors: Ioana R. Marian, Esther Williamson, Angela Garrett, Sarah E. Lamb and Susan J. Dutton

    Citation: Trials 2020 21:667

    Content type: Update

    Published on:

  48. To assess the efficacy of local intranasal treatment with budesonide (nasal irrigation), in addition to olfactory rehabilitation, in the management of loss of smell in COVID-19 patients without signs of severi...

    Authors: Mary Daval, Alain Corré, Clement Palpacuer, Juliette Housset, Guillaume Poillon, Michael Eliezer, Benjamin Verillaud, Dorsaf Slama, Denis Ayache, Philippe Herman, Clement Jourdaine, Camille Hervé, Wissame El Bakkouri, Dominique Salmon and Charlotte Hautefort

    Citation: Trials 2020 21:666

    Content type: Letter

    Published on:

  49. In the past two decades, the massive scale-up of long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) has led to significant reductions in malaria mortality and morbidity. Nonetheless, the...

    Authors: Guofa Zhou, Ming-chieh Lee, Harrysone E. Atieli, John I. Githure, Andrew K. Githeko, James W. Kazura and Guiyun Yan

    Citation: Trials 2020 21:665

    Content type: Study protocol

    Published on:

  50. Mental health recovery narratives have been defined as first-person lived experience accounts of recovery from mental health problems which refer to events or actions over a period of time and which include el...

    Authors: Stefan Rennick-Egglestone, Rachel Elliott, Melanie Smuk, Clare Robinson, Sylvia Bailey, Roger Smith, Jeroen Keppens, Hannah Hussain, Kristian Pollock, Pim Cuijpers, Joy Llewellyn-Beardsley, Fiona Ng, Caroline Yeo, James Roe, Ada Hui, Lian van der Krieke…

    Citation: Trials 2020 21:661

    Content type: Study protocol

    Published on:

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