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  1. Over 200 million individuals worldwide are infected with Schistosoma species, with over half of infections occurring in children. Many children experience first infections early in life and this impacts their gro...

    Authors: Emily L. Webb, Andrew Edielu, Hannah W. Wu, Narcis B. Kabatereine, Edridah M. Tukahebwa, Alfred Mubangizi, Moses Adriko, Alison M. Elliott, William W. Hope, Patrice A. Mawa, Jennifer F. Friedman and Amaya L. Bustinduy

    Citation: Trials 2021 22:601

    Content type: Study protocol

    Published on:

  2. Canadians of South Asian (SA) origin comprise the largest racialized group in Canada, representing 25.6% of what Statistics Canada terms “visible minority populations”. South Asian Canadians are disproportiona...

    Authors: Farooq Naeem, Andrew Tuck, Baldev Mutta, Puneet Dhillon, Gary Thandi, Azaad Kassam, Nimo Farah, Aamna Ashraf, M. Ishrat Husain, M. Omair Husain, Helen-Maria Vasiliadis, Marcos Sanches, Tariq Munshi, Maureen Abbott, Nicholas Watters, Sean A. Kidd…

    Citation: Trials 2021 22:600

    Content type: Study protocol

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  3. Up to 33% of women develop symptoms of posttraumatic stress disorder (PTSD) after a traumatic birth experience. Negative and traumatic childbirth experiences can also lead to fear of childbirth, avoiding or ne...

    Authors: Y. M. G. A. Hendrix, K. S. M. van Dongen, A. de Jongh and M. G. van Pampus

    Citation: Trials 2021 22:599

    Content type: Study protocol

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  4. Randomised controlled trials (RCTs) are the gold standard for demonstrating the efficacy of new therapies. However, issues of external validity often affect result application to real-world settings. Using reg...

    Authors: Ellen Murphy, Aoife O’Keeffe, Niamh O Shea, Eva Long, Joseph A. Eustace and Frances Shiely

    Citation: Trials 2021 22:597

    Content type: Research

    Published on:

  5. The objective of this study will be to investigate the additional effect of pain neuroscience education program compared to a craniocervical manual therapy and exercises program for pain intensity and disabili...

    Authors: Aroldo dos Santos Aguiar, Cesar Bataglion, Lilian Ramiro Felício, Beatriz Azevedo and Thaís Cristina Chaves

    Citation: Trials 2021 22:596

    Content type: Study protocol

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  6. Chronic lower limb ischemia develops earlier and more frequently in patients with type 2 diabetes mellitus. Diabetes remains the main cause of lower-extremity non-traumatic amputations. Current medical treatme...

    Authors: Barbara Soria-Juan, Mariano Garcia-Arranz, Lucía Llanos Jiménez, César Aparicio, Alejandro Gonzalez, Ignacio Mahillo Fernandez, Luis Riera del Moral, Lukasz Grochowicz, Enrique J. Andreu, Pedro Marin, Gregorio Castellanos, Jose Maria Moraleda, Ana Maria García-Hernández, Francisco S. Lozano, Fermin Sanchez-Guijo, Eva María Villarón…

    Citation: Trials 2021 22:595

    Content type: Study protocol

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  7. Post-traumatic stress disorder (PTSD) is a significant public health problem, affecting approximately 7% of the general population and 13–18% of the combat Veteran population. The first study using acupuncture...

    Authors: Michael Hollifield, An-Fu Hsiao, Kala Carrick, Andrea Gory Munoz, Teresa Calloway, Karen Cocozza, Besa Smith, Tyler Smith, Tanja Jovanovic, Seth Norrholm, Estate Sokhadze and Christopher Reist

    Citation: Trials 2021 22:594

    Content type: Study protocol

    Published on:

  8. Vaccine hesitancy is a major hurdle for stopping the COVID-19 pandemic. Recently, fear of vaccine side effects created widespread concern and paused global vaccination efforts. Many studies find that how medic...

    Authors: Nikkil Sudharsanan, Caterina Favaretti, Violetta Hachaturyan, Till Bärnighausen and Alain Vandormael

    Citation: Trials 2021 22:592

    Content type: Letter

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  9. The study objective is to quantify the effectiveness of ivermectin (subcutaneous/oral IVM) in the presence or absence of zinc (Zn) for clinical and radiological improvement in coronavirus disease 2019 (COVID-1...

    Authors: Shoaib Ashraf, Sohaib Ashraf, Iqra Farooq, Sidra Ashraf, Moneeb Ashraf, Muhammad Ahmad Imran, Larab Kalsoom, Rutaba Akmal, Muhammad Ghufran, Sundas Rafique, Muhammad Kiwan Akram, Zaigham Habib, Uzma Nasim Siddiqui, Ammara Ahmad, Shahroze Arshad, Muhammad Abdul Rehman Virk…

    Citation: Trials 2021 22:591

    Content type: Letter

    Published on:

  10. There is no strong evidence that any drug is beneficial either for the treatment of SARS-CoV-2 disease or for post-exposure prophylaxis. Therefore, clinical research is crucial to generate results and evaluate...

    Authors: Elena Bustamante Estebanez, Lucía Lavín Alconero, Beatriz Josa Fernández, Monica Gozalo Marguello, Juan Carlos López Caro, Jonathan Diez Vallejo, Marta Fernandez Sampedro, Pedro Muñoz Cacho, Carlos Richard Espiga and María Mar García Saiz

    Citation: Trials 2021 22:590

    Content type: Study protocol

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  11. Deferred consent is used to recruit patients in emergency research, when informed consent cannot be obtained prior to enrolment. This model of consent allows studies to recruit larger numbers of participants, ...

    Authors: Timia Raven-Gregg and Victoria Shepherd

    Citation: Trials 2021 22:589

    Content type: Commentary

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  12. Considering the important role of education in promoting parents’ attachment to the infant, temporal and spatial limitations, and the need to use new educational methods for spouses’ participation in childbirt...

    Authors: Zari Doaltabadi and Leila Amiri-Farahani

    Citation: Trials 2021 22:588

    Content type: Research

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  13. Falls are one of the most common accidents in older adults, often leading to injury, disability and quality-of-life declines. Foot core function contributes to postural stability in most static postures and dy...

    Authors: Zhangqi Lai, Hongbo Pang, Xiaoyue Hu, Kun Dong and Lin Wang

    Citation: Trials 2021 22:587

    Content type: Study protocol

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  14. Non-specific chronic neck pain (NCNP) is a common musculoskeletal disorder which has caused a huge economic burden due to its expensive health costs and high re-occurrence rate. Yijinjing and Tuina are widely ...

    Authors: Ziji Cheng, Ziying Chen, Fangfang Xie, Chong Guan, Yuanjia Gu, Ruiping Wang, Yanli You and Fei Yao

    Citation: Trials 2021 22:586

    Content type: Study protocol

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  15. Major depressive disorder is the second leading cause of years lost to disability worldwide. Anyu Peibo Capsule has been shown to be effective and safe in phase II trials.

    Authors: Jingjing Huang, Yimin Yu, Yi Jiang, Wu Chen, Yan Li, Yifeng Shen, Qingshan Zheng and Huafang Li

    Citation: Trials 2021 22:585

    Content type: Study protocol

    Published on:

  16. The primary objective of the study is to demonstrate the efficacy of low-dose IFN-β in reducing the risk of SARS-CoV-2 recently infected elderly patients to progress towards severe COVID-19 versus control group w...

    Authors: Eleonora Aricò, Luciano Castiello, Laura Bracci, Francesca Urbani, Flavia Lombardo, Ilaria Bacigalupo, Antonio Ancidoni, Nicola Vanacore, Alessandro Falcione, Chiara Reggiani, Giovanni Marco Dutti, Maria Grazia Maglie, Ombretta Papa, Pier Luigi Bartoletti, Giuseppina Ozzella, Nazario Bevilacqua…

    Citation: Trials 2021 22:584

    Content type: Letter

    Published on:

  17. Authors: Moses Badio, Edouard Lhomme, Mark Kieh, Abdoul Habib Beavogui, Stephen B. Kennedy, Seydou Doumbia, Bailah Leigh, Samba O. Sow, Alpha Diallo, Daniela Fusco, Matthew Kirchoff, Monique Termote, Renaud Vatrinet, Deborah Wentworth, Helène Esperou, H. Clifford Lane…

    Citation: Trials 2021 22:583

    Content type: Correction

    Published on:

    The original article was published in Trials 2021 22:86

  18. Nut consumption has been related to improvements on cardiometabolic parameters and reduction in the severity of atherosclerosis mainly in primary cardiovascular prevention. The objective of this trial is to ev...

    Authors: Aline Marcadenti, Bernardete Weber, Angela Cristine Bersch-Ferreira, Rachel Helena Vieira Machado, Camila Ragne Torreglosa, Enilda Maria de Sousa Lara, Lucas Ribeiro da Silva, Renato Hideo Nakagawa Santos, Debora Harumi Kodama Miyada, Erica Regina Ribeiro Sady, Rosana Perim Costa, Leopoldo Piegas, Erlon Oliveira de Abreu-Silva, Alexandre Schaan de Quadros, Camila Weschenfelder, Júlia Lorenzon dos Santos…

    Citation: Trials 2021 22:582

    Content type: Study protocol

    Published on:

  19. Older people account for 25% of all Emergency Department (ED) admissions. This is expected to rise with an ageing demographic. Older people often present to the ED with complex medical needs in the setting of ...

    Authors: Aoife Leahy, Rachel McNamara, Catriona Reddin, Gillian Corey, Ida Carroll, Aoife O’Neill, Darragh Flannery, Collette Devlin, Louise Barry, Brian MacCarthy, Niamh Cummins, Elaine Shanahan, Denys Shchetkovsky, Damien Ryan, Margaret O’Connor and Rose Galvin

    Citation: Trials 2021 22:581

    Content type: Study protocol

    Published on:

  20. Stress fractures are a common and potentially debilitating overuse injury to bone and occur frequently among military recruits and athletes. Recovery from a lower body stress fracture typically requires severa...

    Authors: Alexander T. Carswell, Katharine G. Eastman, Anna Casey, Matthew Hammond, Lee Shepstone, Estelle Payerne, Andoni P. Toms, James W. MacKay, Ann Marie Swart, Julie P. Greeves and William D. Fraser

    Citation: Trials 2021 22:580

    Content type: Study protocol

    Published on:

  21. Most cancer survivors are married, and cancer strains the physical and mental health of each partner and their intimate relationship. We created a partnered strength training program, Exercising Together©, whe...

    Authors: Kerri M. Winters-Stone, Karen S. Lyons, Nathan F. Dieckmann, Christopher S. Lee, Zahi Mitri and Tomasz M. Beer

    Citation: Trials 2021 22:579

    Content type: Study protocol

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  22. The SARS-CoV-2 pandemic has disrupted clinical trials worldwide. The European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) has tracked clinical trial disruption by surveying its 58 trial sites ac...

    Authors: Silke van Koningsbruggen-Rietschel, Fiona Dunlevy, Veerle Bulteel, Kate Hayes, Anne Verbrugge, Hettie M. Janssens, Nadine Dufeu, Nicholas J. Simmonds, Lieven J. Dupont and Damian G. Downey

    Citation: Trials 2021 22:578

    Content type: Commentary

    Published on:

  23. Presently available medications and surgical treatments for Parkinson’s disease have limited effects on fine motor problems and often leave patients with significant fine motor disability. Standard of care occ...

    Authors: Isabelle Buard, Lucas Lattanzio, Rebekah Stewart, Sarah Thompson, Kristin Sjoberg, Karen Hookstadt, Meghan Morrow, Samantha K. Holden, Stefan Sillau, Michael Thaut and Benzi Kluger

    Citation: Trials 2021 22:577

    Content type: Study protocol

    Published on:

  24. Although catheter ablation is an effective therapy for atrial fibrillation (AF), the most common cardiac arrhythmia encountered in clinical practice, AF ablation generates inflammation and oxidative stress in ...

    Authors: Matthew J. O’Neill, Zachary T. Yoneda, Diane M. Crawford, Fei Ye, Mingfang Ao, Lisa M. Pitchford, John A. Rathmacher, Katherine T. Murray, Wendell S. Akers, Dan M. Roden, Gregory F. Michaud and M. Benjamin Shoemaker

    Citation: Trials 2021 22:576

    Content type: Study protocol

    Published on:

  25. Stroke results in varying physical, cognitive, emotional and/or social disabilities in the short and long term alike. Motor impairments are important, persistent consequences of stroke and include, among other...

    Authors: Susanne Lillelund Sørensen, Simon Svanborg Kjeldsen, Sine Secher Mortensen, Ulla Torp Hansen, Dorthe Hansen, Asger Roger Pedersen and Hanne Pallesen

    Citation: Trials 2021 22:575

    Content type: Study protocol

    Published on:

  26. Mechanical neck pain (MNP) is a commonly occurring musculoskeletal condition that is usually managed using electrical modalities, joint mobilization techniques, and therapeutic exercises, but has limited evide...

    Authors: Prabu Raja G, Shyamasunder Bhat N, César Fernández-de-las-Peñas, Ranganath Gangavelli, Fiddy Davis, Ravi Shankar and Anupama Prabhu

    Citation: Trials 2021 22:574

    Content type: Study protocol

    Published on:

  27. SARS-CoV-2 binds to membrane-bound angiotensin-converting enzyme 2 (ACE2) which may result in downregulation of membrane-bound ACE2. ACE2 is a key regulator of the renin-angiotensin system (RAS) and is respons...

    Authors: Carinna Hockham, Sradha Kotwal, Arlen Wilcox, Abhinav Bassi, James McGree, Carol Pollock, Louise M. Burrell, Nikita Bathla, Mallikarjuna Kunigari, Vinay Rathore, Michael John, Enmoore Lin, Christine Jenkins, Angus Ritchie, Andrew McLachlan, Thomas Snelling…

    Citation: Trials 2021 22:573

    Content type: Study protocol

    Published on:

  28. An alveolar cleft commonly affects 75% of cleft lip and palate patients. While it is common practice to provide a course of orthodontic treatment before alveolar bone grafting, there are no previous high-quali...

    Authors: Badri Thiruvenkatachari, Syed Altaf Hussain, Puneet Batra, Charanya Vijayakumar and Manoj Prathap. C

    Citation: Trials 2021 22:572

    Content type: Study protocol

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  29. Community-acquired pneumonia (CAP) is a leading cause of hospitalization worldwide. Bed rest with low levels of physical activity is common during periods of hospitalization and leads to functional decline as ...

    Authors: Camilla Koch Ryrsø, Daniel Faurholt-Jepsen, Christian Ritz, Bente Klarlund Pedersen, Maria Hein Hegelund, Arnold Matovu Dungu, Adin Sejdic, Birgitte Lindegaard and Rikke Krogh-Madsen

    Citation: Trials 2021 22:571

    Content type: Study protocol

    Published on:

  30. Globally, the ongoing pursuit in exploring an effective drug to combat severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus has not met with significant success to date. Indian traditional medici...

    Authors: Anurag Srivastava, Manickavasagam Rengaraju, Saurabh Srivastava, Vimal Narayanan, Vivek Gupta, Rashmi Upadhayay, Jitender Kumar, Sathiyarajeswaran Parameswaran, KanakavalliKadarkarai and AarthiVelmurugan

    Citation: Trials 2021 22:570

    Content type: Research

    Published on:

  31. There is an international interest in whether improved primary care can lead to a more rational use of health resources. There is evidence that educational interventions can lead to improvements in the quality...

    Authors: Andrew Bonney, Christine Metusela, Judy Mullan, Stephen Barnett, Joel Rhee, Conrad Kobel and Marijka Batterham

    Citation: Trials 2021 22:569

    Content type: Study protocol

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  32. Pancreatic ductal adenocarcinoma (PDAC) is a lethal disease, and multimodal strategies, such as surgery plus neoadjuvant chemotherapy (NAC)/adjuvant chemotherapy, have been attempted to improve survival in pat...

    Authors: Daisaku Yamada, Shogo Kobayashi, Hidenori Takahashi, Hirofumi Akita, Terumasa Yamada, Tadafumi Asaoka, Junzo Shimizu, Yutaka Takeda, Shigekazu Yokoyama, Masanori Tsujie, Akira Tomokuni, Masahiro Tanemura, Osakuni Morimoto, Masahiro Murakami, Yongkook Kim, Shin Nakahira…

    Citation: Trials 2021 22:568

    Content type: Study protocol

    Published on:

  33. Recruitment to surgical randomised controlled trials (RCTs) can be challenging. The Sunflower study is a large-scale multi-centre RCT that seeks to establish the clinical and cost effectiveness of pre-operativ...

    Authors: Marcus Jepson, Michelle Lazaroo, Samir Pathak, Natalie Blencowe, Jane Collingwood, Madeleine Clout, Giles Toogood and Jane Blazeby

    Citation: Trials 2021 22:567

    Content type: Research

    Published on:

    The Correction to this article has been published in Trials 2021 22:615

  34. Non-alcohol fatty liver disease (NAFLD) is the most common chronic liver disease in the world, with a high incidence and no effective treatment. At present, the targeted therapy of intestinal microbes for NAFL...

    Authors: Lu-Lu Gao, Yu-Xiang Li, Jia-Min Ma, Yi-Qiong Guo, Lin Li, Qing-Han Gao, Yan-Na Fan, Meng-Wei Zhang, Xiu-Juan Tao, Jian-Qiang Yu and Jian-Jun Yang

    Citation: Trials 2021 22:566

    Content type: Study protocol

    Published on:

  35. This a priori statistical analysis plan describes the analysis for CRISTAL.

    Authors: Verinder Singh Sidhu, Thu-Lan Kelly, Nicole Pratt, Steven Graves, Rachelle Buchbinder, Justine Naylor, Richard de Steiger, Ilana Ackerman, Sam Adie, Michelle Lorimer, Durga Bastiras, Kara Cashman and Ian Harris

    Citation: Trials 2021 22:564

    Content type: Update

    Published on:

  36. This study aimed to evaluate the effect of perioperative transcutaneous electrical acupoint stimulation (TEAS) on postoperative cognitive dysfunction (POCD) in older patients who were diagnosed with gastrointe...

    Authors: Lijuan Xi, Fang Fang, Haijuan Yuan and Daorong Wang

    Citation: Trials 2021 22:563

    Content type: Research

    Published on:

  37. Due to the inherent characteristics of immersion, imagination, and interactivity in virtual reality (VR), it might be suitable for non-drug behavior management of children in dental clinics. The purpose of thi...

    Authors: Longkuan Ran, Nan Zhao, Lin Fan, Pinping Zhou, Chao Zhang and Cong Yu

    Citation: Trials 2021 22:562

    Content type: Research

    Published on:

  38. A recently published article described the safety, tolerability, and pharmacokinetic profile of molnupiravir (Painter et al. 2021), a novel antiviral agent with potent activity against severe acute respiratory...

    Authors: Wendy Holman, Wayne Holman, Stacy McIntosh, Wendy Painter, George Painter, Jim Bush and Oren Cohen

    Citation: Trials 2021 22:561

    Content type: Commentary

    Published on:

  39. Cognitive training with components that can further enhance the transferred and long-term effects and slow the progress of dementia is needed for preventing dementia.

    Authors: Feng V. Lin, Kathi Heffner, Richard Gevirtz, Zhengwu Zhang, Duje Tadin and Anton Porsteinsson

    Citation: Trials 2021 22:560

    Content type: Study protocol

    Published on:

  40. The demand for care during the COVID-19 pandemic has affected the mental health of healthcare workers (HCWs), thus increasing the need for psychosocial support services. Internet-based interventions have previ...

    Authors: Lina Jovarauskaite, Austeja Dumarkaite, Inga Truskauskaite-Kuneviciene, Ieva Jovaisiene, Gerhard Andersson and Evaldas Kazlauskas

    Citation: Trials 2021 22:559

    Content type: Study protocol

    Published on:

  41. Acute kidney injury (AKI) is a common complication of cardiac surgery. Factors such as cardiopulmonary bypass, aortic cross-clamping and surgical stress may precipitate renal hypoperfusion and ischaemia, infla...

    Authors: Mayurathan Balachandran, Piyusha Banneheke, Adrian Pakavakis, Wisam Al-Bassam, Vineet Sarode, Michael Rowland and Yahya Shehabi

    Citation: Trials 2021 22:558

    Content type: Study protocol

    Published on:

  42. Recruitment of fibromyalgia populations into long-term clinical trials involving exercise interventions is a challenge. We evaluated the cost and randomization yields of various recruitment methods used for a ...

    Authors: Michelle Park, Raveendhara R. Bannuru, Lori Lyn Price, William F. Harvey, Jeffrey B. Driban and Chenchen Wang

    Citation: Trials 2021 22:557

    Content type: Research

    Published on:

  43. Colorectal cancer is a major public concern, being the second deadliest cancer in the world. Whereas survival is high for localized forms, metastatic colorectal cancer has showed poor prognosis, with a 5-year ...

    Authors: Muriel Mathonnet, Mathieu Vanderstraete, Christophe Bounaix Morand du Puch, Stéphanie Giraud, Christophe Lautrette, Mehdi Ouaissi, Nicolas Tabchouri, Abdelkader Taïbi, Renaud Martin, Isabelle Herafa, Achille Tchalla and Niki Christou

    Citation: Trials 2021 22:556

    Content type: Study protocol

    Published on:

  44. Esophagogastroduodenoscopy is very useful in diagnosing and treating upper gastrointestinal mucosal disorders, but too much foam and water in stomach decrease its diagnostic efficiency. Simethicone administrat...

    Authors: Xiaotian Sun, Yang Xu, Xueting Zhang, Cuiyun Ma, Aitong Li, Haiyan Yu, Weihua Zhang, Hanqing Zhang, Teng Yang, Xinfang Miao, Huiming Zhang, Yan Liu and Zheng Lu

    Citation: Trials 2021 22:555

    Content type: Research

    Published on:

  45. Loss to follow-up resulting in missing outcomes compromises the validity of trial results by reducing statistical power, negatively affecting generalisability and undermining assumptions made at analysis, lead...

    Authors: Edmund Juszczak, Oliver Hewer, Christopher Partlett, Madeleine Hurd, Vasha Bari, Ursula Bowler, Louise Linsell and Jon Dorling

    Citation: Trials 2021 22:554

    Content type: Methodology

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  46. With the increased understanding of heart disease, microvascular angina (MVA) is receiving greater attention from clinicians. Studies have shown that patients with MVA have significantly higher major cardiovas...

    Authors: Yuanlong Sun, Chengxin Huang, Li Huo, Ying Li, Jun Chen, Zixiu Zhang, Meijun Jia, Meixian Jiang and Xiaofen Ruan

    Citation: Trials 2021 22:553

    Content type: Study protocol

    Published on:

  47. SiFAr-Stress investigates the impact of cycling on stress levels in older adults. Uncertainty due to change to motorized bicycle or fear of falling can be perceived as stressors for cyclists. Stress activates ...

    Authors: Sabine Britting, Robert Kob, Cornel Christian Sieber, Nicolas Rohleder, Ellen Freiberger and Linda Becker

    Citation: Trials 2021 22:552

    Content type: Study protocol

    Published on:

  48. After receiving breast cancer surgery or reconstruction, shoulder dysfunctions including weakness, post-operative pain, shoulder joint instability, and limited range of motion (ROM) often occur. Due to limited...

    Authors: Hae-Yeon Park, Kyung Eun Nam, Jae-Young Lim, Seung Mi Yeo, Jong In Lee and Ji Hye Hwang

    Citation: Trials 2021 22:549

    Content type: Study protocol

    Published on:

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