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  1. HPV infection is the primary cause of cervical cancer, a leading cause of cancer among women in Kenya and many sub-Saharan African countries. High coverage of HPV vaccination is a World Health Organization pri...

    Authors: Ruanne V. Barnabas, Elizabeth R. Brown, Maricianah Onono, Elizabeth A. Bukusi, Betty Njoroge, Rachel L. Winer, Deborah Donnell, Denise Galloway, Stephen Cherne, Kate Heller, Hannah Leingang, Susan Morrison, Elena Rechkina, R. Scott McClelland, Jared M. Baeten, Connie Celum…

    Citation: Trials 2021 22:661

    Content type: Study protocol

    Published on:

  2. Randomized trials of assisted reproductive technology (ART) have been designed for outcomes of clinical pregnancy or live birth and have not been powered for obstetric outcomes such as preeclampsia, critical f...

    Authors: Sheriza Baksh, Anne Casper, Mindy S. Christianson, Kate Devine, Kevin J. Doody, Stephan Ehrhardt, Karl R. Hansen, Ruth B. Lathi, Fatmata Timbo, Rebecca Usadi, Wendy Vitek, David M. Shade, James Segars and Valerie L. Baker

    Citation: Trials 2021 22:660

    Content type: Study protocol

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  3. Type 2 diabetes mellitus (T2DM) and coronary heart disease (CHD) are two chronic diseases that cause a tremendous burden. To reduce this burden, several programmes for optimising the care for these diseases ha...

    Authors: Uwe Konerding, Marcus Redaèlli, Karolin Ackermann, Sibel Altin, Sebastian Appelbaum, Bianca Biallas, August-Wilhelm Bödecker, Suzan Botzenhardt, Chloé Chermette, Martin Cichocki, Iris Dapper, Katja Dehnen, Christian Funke, Angeli Gawlik, Lisa Giesen, Johannes Goetz…

    Citation: Trials 2021 22:659

    Content type: Study protocol

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  4. Information about and invitation to participate in a clinical trial involving an intervention during childbirth may cause fear or worry in pregnant women. The aim of this study was to describe nulliparous wome...

    Authors: Jenny Ericson, Cecilia Anagrius, Agnes Rygaard, Lisa Guntram, Sophia Brismar Wendel and Susanne Hesselman

    Citation: Trials 2021 22:658

    Content type: Research

    Published on:

  5. Infertility is a widespread global challenge. Currently, the most effective treatment strategy for infertility is in vitro fertilization (IVF), which is an assisted reproductive technique (ART). The use of IVF...

    Authors: Ying-jie Ma, Xian-ling Cao, Ting Ma, Jing-yan Song, Ling-yu Yu, Yang-yang Yu, Jian-Yun Zhao and Zhen-Gao Sun

    Citation: Trials 2021 22:657

    Content type: Study protocol

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  6. To achieve higher effectiveness in population-based SARS-CoV-2 surveillance and to reliably predict the course of an outbreak, screening, and monitoring of infected individuals without major symptoms (about 40...

    Authors: Andreas Deckert, Simon Anders, Manuela De Allegri, Hoa Thi Nguyen, Aurélia Souares, Shannon McMahon, Matthias Meurer, Robin Burk, Matthias Sand, Lisa Koeppel, Lena Maier Hein, Tobias Roß, Tim Adler, Tobias Siems, Lucia Brugnara, Stephan Brenner…

    Citation: Trials 2021 22:656

    Content type: Study protocol

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    The Letter to this article has been published in Trials 2021 22:39

  7. Primary dysmenorrhea (PD) is the most common complaint in young women and adolescents. Side effects of non-steroidal anti-inflammatory drugs can limit their use. Therefore, non-pharmacological pain relief meth...

    Authors: Masoomeh Vahedi, Seyedeh Batool Hasanpoor-Azghady, Leila Amiri-Farahani and Imaneh Khaki

    Citation: Trials 2021 22:655

    Content type: Research

    Published on:

  8. A promising approach to reduce the increasing costs of clinical trials is the use of routinely collected health data as participant data. However, the quality of this data could limit its usability as trial pa...

    Authors: Sharon B. Love, Anna Kilanowski, Victoria Yorke-Edwards, Oliver Old, Hugh Barr, Clive Stokes, Catherine Kendall and Matthew R. Sydes

    Citation: Trials 2021 22:654

    Content type: Research

    Published on:

  9. First-line treatment for prolactinomas is a medical treatment with dopamine agonists (DAs), which effectively control hyperprolactinaemia in most patients, although post-withdrawal remission rates are approxim...

    Authors: Ingrid M. Zandbergen, Amir H. Zamanipoor Najafabadi, Iris C. M. Pelsma, M. Elske van den Akker-van Marle, Peter H. L. T. Bisschop, H. D. Jeroen Boogaarts, Arianne C. van Bon, Bakhtyar Burhani, Saskia le Cessie, Olaf M. Dekkers, Madeleine L. Drent, Richard A. Feelders, Johan P. de Graaf, J. Hoogmoed, Kitty K. Kapiteijn, Melanie M. van der Klauw…

    Citation: Trials 2021 22:653

    Content type: Study protocol

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  10. Acute renal colic caused by urinary calculi (ARCUC) has a considerable impact on the quality of life. Acupuncture might be a potential treatment option. However, the evidence is limited. We will conduct this t...

    Authors: Ying Cao, Jian-Feng Tu, Guang-Xia Shi, Li-Qiong Wang, Lian-Cheng Jia, Bo Li, Bao-Li Liu, Wei-Hai Yao, Xiao-Lu Pei, Zhi-Cheng Qu and Cun-Zhi Liu

    Citation: Trials 2021 22:652

    Content type: Study protocol

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  11. Treatment of multidrug- and rifampin-resistant tuberculosis (MDR/RR-TB) is expensive, labour-intensive, and associated with substantial adverse events and poor outcomes. While most MDR/RR-TB patients do not re...

    Authors: L. Guglielmetti, E. Ardizzoni, M. Atger, E. Baudin, E. Berikova, M. Bonnet, E. Chang, S. Cloez, J. M. Coit, V. Cox, B. C. de Jong, C. Delifer, J. M. Do, D. Dos Santos Tozzi, V. Ducher, G. Ferlazzo…

    Citation: Trials 2021 22:651

    Content type: Study protocol

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  12. Cognitive deficit is a common syndrome of methamphetamine (MA) dependence. It is related to decision-making, control ability, and social functioning. High-intensity interval training (HIIT) is a training techn...

    Authors: Shen Menglu, Yang Suyong, Wang Xiaoyan, Wolfgang I. Schöllhorn and Zhu Dong

    Citation: Trials 2021 22:650

    Content type: Study protocol

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  13. Anaemia is a worldwide problem and iron deficiency is the most common cause. In pregnancy, anaemia increases the risk of adverse maternal, foetal and neonatal outcomes.

    Authors: Richard J. Derman, Shivaprasad S. Goudar, Simal Thind, Sudhir Bhandari, Zubair Aghai, Michael Auerbach, Rupsa Boelig, Umesh S. Charantimath, Rosemary Frasso, M. S. Ganachari, Kusum Lata Gaur, Michael K. Georgieff, Frances Jaeger, S Yogeshkumar, Parth Lalakia, Benjamin Leiby…

    Citation: Trials 2021 22:649

    Content type: Study protocol

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  14. This paper describes the statistical analysis plan for a randomised controlled trial of a Healthy Lifestyle Program (HeLP) for low back pain targeting multiple health risks and behaviours, weight, physical act...

    Authors: Emma Robson, Steven J. Kamper, Alix Hall, Hopin Lee, Simon Davidson, Priscilla Viana da Silva, Connor Gleadhill and Christopher M. Williams

    Citation: Trials 2021 22:648

    Content type: Study protocol

    Published on:

  15. Transcranial direct current stimulation (tDCS) has the potential to modulate cortical excitability and enhance the effects of walking training in people with Parkinson’s disease. This study will examine the ef...

    Authors: Lucas Rodrigues Nascimento, Ester Miyuki Nakamura-Palacios, Augusto Boening, Daniel Lyrio Cabral, Alessandra Swarowsky, Guilherme Peixoto Tinoco Arêas, Wellingson Silva Paiva and Fernando Zanela da Silva Arêas

    Citation: Trials 2021 22:647

    Content type: Study protocol

    Published on:

  16. Citation: Trials 2021 22:646

    Content type: Correction

    Published on:

    The original article was published in Trials 2021 22:506

  17. Hypermobility is a poorly recognised and understood musculoskeletal disorder thought to affect around 20% of the population. Hypermobility is associated with reduced physiological and psychological functioning...

    Authors: Geoff Davies, Jenny L. L. Csecs, Heather Ball, Jess Dare, Stephen Bremner, Robin Hosking, Hugo D. Critchley, Nick Grey and Jessica A. Eccles

    Citation: Trials 2021 22:645

    Content type: Study protocol

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  18. Intervention fidelity is the core component of a well-designed clinical trial and processes that are used to ensure that the study intervention is delivered as planned. It affects the design and implementation...

    Authors: Mimi M. Y. Tse, Shuk Kwan Tang, Shamay Ng, Yajie Li, Daphne Sze Ki Cheung and Rick Yiu Cho Kwan

    Citation: Trials 2021 22:644

    Content type: Research

    Published on:

  19. Acute respiratory distress syndrome (ARDS) is a complex clinical diagnosis with various possible etiologies. One common feature, however, is pulmonary permeability edema, which leads to an increased alveolar d...

    Authors: Benedikt Schmid, Markus Kredel, Roman Ullrich, Katharina Krenn, Rudolf Lucas, Klaus Markstaller, Bernhard Fischer, Peter Kranke, Patrick Meybohm, Bernhard Zwißler and Sandra Frank

    Citation: Trials 2021 22:643

    Content type: Study protocol

    Published on:

  20. Colorectal cancer is one the most common cancers in the western world with increasing incidence. Approximately 50% of the patients develop liver metastases. Resection of liver metastases is the treatment of ch...

    Authors: Sheraz Yaqub, Bjørn Atle Bjørnbeth, Jon-Helge Angelsen, Claus Wilki Fristrup, Jon Erik Grønbech, Oskar Hemmingsson, Bengt Isaksson, Ingebjørg Soterud Juel, Peter Nørgaard Larsen, Gert Lindell, Frank Viborg Mortensen, Kim Erlend Mortensen, Magnus Rizell, Per Sandström, Oddvar Mathias Sandvik, Ernesto Sparrelid…

    Citation: Trials 2021 22:642

    Content type: Study protocol

    Published on:

  21. Targeting low self-esteem in youth exposed to childhood adversity is a promising strategy for preventing adult mental disorder, but psychological help remains difficult to access and accept for youth, calling ...

    Authors: Maud Daemen, Mary Rose Postma, Ramon Lindauer, Iris Hoes-van der Meulen, Dorien Nieman, Philippe Delespaul, Josefien Johanna Froukje Breedvelt, Mark van der Gaag, Wolfgang Viechtbauer, Koen Schruers, David van den Berg, Claudi Bockting, Therese van Amelsvoort and Ulrich Reininghaus

    Citation: Trials 2021 22:641

    Content type: Study protocol

    Published on:

  22. Time management skills are essential for living in modern society. People with mental or neurodevelopmental disorders typically have cognitive limitations, including affected time management, which might lead ...

    Authors: Marie Holmefur, Afsaneh Roshanay, Suzanne White, Gunnel Janeslätt, Elin Vimefall and Kajsa Lidström-Holmqvist

    Citation: Trials 2021 22:640

    Content type: Study protocol

    Published on:

  23. Heparin is used worldwide for 70 years during all non-cardiac arterial procedures (NCAP) to reduce thrombo-embolic complications (TEC). But heparin also increases blood loss causing possible harm for the patie...

    Authors: Arno M. Wiersema, Liliane C. Roosendaal, Mark J. W. Koelemaij, Jan G. P. Tijssen, Susan van Dieren, Jan D. Blankensteijn, E. Sebastian Debus, Saskia Middeldorp, Jan M. M. Heyligers, Ymke S. Fokma, Michel M. P. J. Reijnen and Vincent Jongkind

    Citation: Trials 2021 22:639

    Content type: Study protocol

    Published on:

  24. Sleep apnea and coronary artery disease are prevalent and relevant diseases. The mechanism by which sleep apnea leads to coronary artery disease remains unclear. Intermittent hypoxia, caused by sleep apnea, le...

    Authors: Leticia Maria Tedesco Silva, Antonio Cortes, Beatriz Rossi, Liliana Boll, Gustavo Waclawosky, Bruna Eibel, Sandro Cadaval Gonçalves, Maria Claudia Irigoyen and Denis Martinez

    Citation: Trials 2021 22:638

    Content type: Study protocol

    Published on:

  25. Most hospitalized preterm infants experience difficulties in transitioning from tube feeding to full oral feeding. Interventions to promote full oral feeding in preterm infants in the neonatal intensive care u...

    Authors: Liling Li, Li Wang, Conway Niu, Chan Liu, Tianchan Lv, Futing Ji, Ling Yu, Weili Yan, Ya Lan Dou, Yin Wang, Yun Cao, Guoying Huang and Xiaojing Hu

    Citation: Trials 2021 22:637

    Content type: Study protocol

    Published on:

  26. Financial toxicity, the material and psychological burden of the cost of treatment, affects 30–50% of people with cancer, even those with health insurance. The burden of treatment cost can affect treatment adh...

    Authors: Lauren M. Hamel, David W. Dougherty, Seongho Kim, Elisabeth I. Heath, Lorna Mabunda, Eyouab Tadesse, RaeAnn Hill and Susan Eggly

    Citation: Trials 2021 22:636

    Content type: Study protocol

    Published on:

  27. Palliative care is a medical specialty centered on improving the quality of life (QOL) of patients with complex or life-threatening illnesses. The need for palliative care is increasing and with that the rigor...

    Authors: Patrick M. Wilson, Lindsey M. Philpot, Priya Ramar, Curtis B. Storlie, Jacob Strand, Alisha A. Morgan, Shusaku W. Asai, Jon O. Ebbert, Vitaly D. Herasevich, Jalal Soleimani and Brian W. Pickering

    Citation: Trials 2021 22:635

    Content type: Study protocol

    Published on:

  28. Optimal management of severe trauma patients with active hemorrhage relies on adequate initial resuscitation. Early administration of coagulation factors improves post-traumatic coagulation disorders, and four...

    Authors: Pierre Bouzat, Jean-Luc Bosson, Jean-Stéphane David, Bruno Riou, Jacques Duranteau and Jean-François Payen

    Citation: Trials 2021 22:634

    Content type: Study protocol

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  29. Radical antegrade modular pancreatosplenectomy (RAMPS) is an isolation procedure in pancreatosplenectomy for pancreatic body/tail cancer. Connective tissues around the bifurcation of the celiac axis are dissec...

    Authors: Ken-ichi Okada, Manabu Kawai, Seiko Hirono, Masayuki Sho, Masaji Tani, Ippei Matsumoto, Suguru Yamada, Ryosuke Amano, Hirochika Toyama, Yo-ichi Yamashita, Takeshi Gocho, Kazuto Shibuya, Minako Nagai, Hiromitsu Maehira, Keiko Kamei, Go Ohira…

    Citation: Trials 2021 22:633

    Content type: Study protocol

    Published on:

  30. We aim to study the effect of epidural morphine as a means to reduce high respiratory drive in COVID 19 patients on non-invasive ventilation (NIV)—primary end point—and to study its effect on respiratory param...

    Authors: Swagata Tripathy and P. Bhaskar Rao

    Citation: Trials 2021 22:632

    Content type: Letter

    Published on:

  31. Metastatic prostate cancer remains a lethal malignancy that warrants novel supportive interventions for patients and their decision partners and proxies. Decision aids have been applied primarily to patients w...

    Authors: Lourdes R. Carhuapoma, Winter M. Thayer, Catherine E. Elmore, Jane Gildersleeve, Tanmay Singh, Farah Shaukat, Melissa K. Uveges, Tamryn Gray, Crystal Chu, Daniel Song, Patricia J. Hollen, Jennifer Wenzel and Randy A. Jones

    Citation: Trials 2021 22:631

    Content type: Study protocol

    Published on:

  32. Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease—including HIV/AIDS. Additionally, depression is a leading cause of disability in the c...

    Authors: Ryan K. McBain, Owen Mwale, Todd Ruderman, Waste Kayira, Emilia Connolly, Mark Chalamanda, Chiyembekezo Kachimanga, Brown David Khongo, Jesse Wilson, Emily Wroe, Giuseppe Raviola, Stephanie Smith, Sarah Coleman, Ksakrad Kelly, Amruta Houde, Mahlet G. Tebeka…

    Citation: Trials 2021 22:630

    Content type: Study protocol

    Published on:

  33. Universal Health Coverage ensures access to quality health services for all, with no financial hardship when accessing the needed services. Nevertheless, access to quality health services is marred by substant...

    Authors: Amanuel Abajobir, Richard de Groot, Caroline Wainaina, Anne Njeri, Daniel Maina, Silvia Njoki, Nelson Mbaya, Hermann Pythagore Pierre Donfouet, Menno Pradhan, Wendy Janssens and Estelle M. Sidze

    Citation: Trials 2021 22:629

    Content type: Study protocol

    Published on:

  34. Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Alt...

    Authors: Tim Hundscheid, Rogier Donders, Wes Onland, Elisabeth M. W. Kooi, Daniel C. Vijlbrief, Willem B. de Vries, Debbie H. G. M. Nuytemans, Bart van Overmeire, Antonius L. Mulder and Willem P. de Boode

    Citation: Trials 2021 22:627

    Content type: Update

    Published on:

    The Study protocol to this article has been published in BMC Pediatrics 2018 18:262

  35. Some parallel-group cluster-randomized trials use covariate-constrained rather than simple randomization. This is done to increase the chance of balancing the groups on cluster- and patient-level baseline char...

    Authors: Ahmed A. Al-Jaishi, Stephanie N. Dixon, Eric McArthur, P. J. Devereaux, Lehana Thabane and Amit X. Garg

    Citation: Trials 2021 22:626

    Content type: Research

    Published on:

  36. Patients in Germany are free to seek care from any office-based physician and can always ask for multiple opinions on a diagnosis or treatment. The high density of physicians and the freedom to choose among th...

    Authors: Leonie Sundmacher, Ronja Flemming, Verena Leve, Isabel Geiger, Sebastian Franke, Thomas Czihal, Clemens Krause, Birgitt Wiese, Frank Meyer, Matthias Brittner, Johannes Pollmanns, Johannes Martin, Paul Brandenburg, Annemarie Schultz, Emmanuelle Brua, Udo Schneider…

    Citation: Trials 2021 22:624

    Content type: Study protocol

    Published on:

  37. Despite several ongoing efforts in biomedicine and traditional medicine, there are no drugs or vaccines for coronavirus disease 2019 (COVID-19) as of May 2020; Kabasura Kudineer (KSK), a polyherbal formulation...

    Authors: S. Natarajan, C. Anbarasi, P. Sathiyarajeswaran, P. Manickam, S. Geetha, R. Kathiravan, P. Prathiba, M. Pitchiahkumar, P. Parthiban, K. Kanakavalli and P. Balaji

    Citation: Trials 2021 22:623

    Content type: Research

    Published on:

  38. Families with minor children affected by parental cancer are at risk of considerable emotional and organizational stress that can severely burden all family members. So far, there has been a lack of comprehens...

    Authors: Marc Dohmen, Andrea Petermann-Meyer, Daniel Blei, Rebecca Bremen, Evamarie Brock-Midding, Manuela Brüne, Franziska Geiser, Burkhard Haastert, Sarah Maria Halbach, Christian Heuser, Steffen Holsteg, Lina Heier, Andrea Icks, Andre Karger, Joseph Montalbo, Hannah Nakata…

    Citation: Trials 2021 22:622

    Content type: Study protocol

    Published on:

  39. Colorectal cancer is associated with secondary sarcopenia (muscle loss) and myosteatosis (fatty infiltration of muscle) and patients who exhibit these host characteristics have poorer outcomes following surger...

    Authors: Edward T. Pring, Laura E. Gould, George Malietzis, Philip Lung, Mina Bharal, Tutu Fadodun, Paul Bassett, Mani Naghibi, Claire Taylor, Ioanna Drami, Deeptika Chauhan, Tamsyn Street, Nader K. Francis, Thanos Athanasiou, John M. Saxton and John T. Jenkins

    Citation: Trials 2021 22:621

    Content type: Study protocol

    Published on:

  40. There is a lack of high-quality evidence underpinning many contemporary clinical practice guidelines embedded in the healthcare systems, leading to treatment uncertainty and practice variation in most medical ...

    Authors: Tom Briffa, Tanya Symons, Nikolajs Zeps, Nicola Straiton, William Odita Tarnow-Mordi, John Simes, Ian A. Harris, Melinda Cruz, Steven A. Webb, Edward Litton, Alistair Nichol and Christopher M. Williams

    Citation: Trials 2021 22:620

    Content type: Commentary

    Published on:

  41. Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders in clinical practice. IBS diagnosis is based on symptoms defined by abdominal pain or discomfort associated with d...

    Authors: Linda L. D. Zhong, Tsz Fung Lam, Wei Yang, Ya Zheng, Zipan Lyu and Zhaoxiang Bian

    Citation: Trials 2021 22:619

    Content type: Study protocol

    Published on:

  42. Considering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS.

    Authors: Sohaib Ashraf, Shoaib Ashraf, Rutaba Akmal, Moneeb Ashraf, Larab Kalsoom, Aadil Maqsood, Muhammad Ahmad Imran, Iqra Farooq, Sidra Ashraf, Uzma Nasim Siddiqui, Muhammad Ghufran, Muhammad Kiwan Akram, Nighat Majeed, Sundas Rafique, Zaigham Habib, Muhammad Sarmad Shahab…

    Citation: Trials 2021 22:618

    Content type: Letter

    Published on:

  43. Tonsillar surgery has been used for decades to treat recurrent and chronic tonsillitis in adults. Recurrent and chronic tonsillitis result in disturbing symptoms, treatment costs, sick leave, and impaired qual...

    Authors: Aleksi Laajala, Paulus Tokola, Timo J. Autio, Timo Koskenkorva, Mikko Tastula, Pasi Ohtonen, Esa Läärä and Olli-Pekka Alho

    Citation: Trials 2021 22:617

    Content type: Study protocol

    Published on:

  44. Internationally, older patients (≥65 years) account for more than 40% of acute admissions. Older patients admitted to the emergency department (ED) are frequently malnourished and exposed to inappropriate medi...

    Authors: Aino L. Andersen, Morten B. Houlind, Rikke L. Nielsen, Lillian M. Jørgensen, Charlotte Treldal, Morten Damgaard, Anne Kathrine Bengaard, Helle Gybel Juul-Larsen, Louise Bolvig Laursen, Esben Iversen, Marie Kruse, Anne M. L. Pedersen, Mads Hornum, Anne M. Beck, Mette M. Pedersen, Mikkel Z. Ankarfeldt…

    Citation: Trials 2021 22:616

    Content type: Study protocol

    Published on:

  45. Stroke is the leading cause of death worldwide. China faces a similar risk of stroke as developed countries because of considerable changes in lifestyle, such as overeating and smoking. Tai Chi is a traditiona...

    Authors: Tianyang Tan, Yanyan Meng, Xinyu Li, Ruina Bai, Chengchao Wang, Jiaxuan Lyu, Kang Yan, Meng Liu, Chaoyang Zhang and Yulong Wei

    Citation: Trials 2021 22:614

    Content type: Study protocol

    Published on:

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