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  1. There is increasing evidence for the use of lower insufflation pressures during laparoscopic surgery. Deep neuromuscular blockade allows for a safe reduction in intra-abdominal pressure without compromising th...

    Authors: Kim I. Albers, Fatih Polat, Ivo F. Panhuizen, Marc M. J. Snoeck, Gert-Jan Scheffer, Hans D. de Boer and Michiel C. Warlé

    Citation: Trials 2020 21:541

    Content type: Study protocol

    Published on:

  2. The quality of clinical care of brain-dead potential organ donors may help reduce donor losses caused by irreversible or unreversed cardiac arrest and increase the number of organs donated. We sought to determ...

    Authors: Natalia Elis Giordani, Caroline Cabral Robinson, Glauco Adrieno Westphal, Regis Goulart Rosa, Daniel Sganzerla, Alexandre Biasi Cavalcanti, Flávia Ribeiro Machado, Luciano Cesar Pontes Azevedo, Fernando Augusto Bozza, Cassiano Teixeira, Joel de Andrade, Cristiano Augusto Franke, Cátia Moreira Guterres, Itiana Cardoso Madalena, Adriane Isabel Rohden, Sabrina Souza da Silva…

    Citation: Trials 2020 21:540

    Content type: Update

    Published on:

  4. Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. ...

    Authors: Munyaradzi Dimairo, Philip Pallmann, James Wason, Susan Todd, Thomas Jaki, Steven A. Julious, Adrian P. Mander, Christopher J. Weir, Franz Koenig, Marc K. Walton, Jon P. Nicholl, Elizabeth Coates, Katie Biggs, Toshimitsu Hamasaki, Michael A. Proschan, John A. Scott…

    Citation: Trials 2020 21:528

    Content type: Methodology

    Published on:

  5. The majority of participants in weight loss trials are non-Hispanic White women, while men and women of color are underrepresented. This study presents data obtained from non-targeted and targeted recruitment ...

    Authors: Melissa M. Crane, Elisabeth M. Seburg, Rona L. Levy, Robert W. Jeffery and Nancy E. Sherwood

    Citation: Trials 2020 21:537

    Content type: Research

    Published on:

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

    Authors: Christina M. Eckhardt, Matthew J. Cummings, Kartik N. Rajagopalan, Sarah Borden, Zachary C. Bitan, Allison Wolf, Alex Kantor, Thomas Briese, Benjamin J. Meyer, Samuel D. Jacobson, Dawn Scotto, Nischay Mishra, Neena M. Philip, Brie A. Stotler, Joseph Schwartz, Beth Shaz…

    Citation: Trials 2020 21:536

    Content type: Correction

    Published on:

    The original article was published in Trials 2020 21:499

  7. Data collection consumes a large proportion of clinical trial resources. Each data item requires time and effort for collection, processing and quality control procedures. In general, more data equals a heavie...

    Authors: Evelyn Crowley, Shaun Treweek, Katie Banister, Suzanne Breeman, Lynda Constable, Seonaidh Cotton, Anne Duncan, Adel El Feky, Heidi Gardner, Kirsteen Goodman, Doris Lanz, Alison McDonald, Emma Ogburn, Kath Starr, Natasha Stevens, Marie Valente…

    Citation: Trials 2020 21:535

    Content type: Methodology

    Published on:

  8. Vaccines may cause non-specific effects (NSEs) on morbidity and mortality through immune-mediated mechanisms that are not explained by the prevention of the targeted disease. Much of the evidence for NSEs come...

    Authors: Darryn Knobel, Christianah Ibironke Odita, Anne Conan, Donna Barry, Marshalette Smith-Anthony, Juliet Battice, Shianne England and Bradford D. Gessner

    Citation: Trials 2020 21:534

    Content type: Study protocol

    Published on:

  9. There has been growing evidence on the favourable outcomes of fast-track-recovery (FTR) surgery; to expedite recovery, minimise complications, and reduce the length of hospital stay for surgical patients. Howe...

    Authors: Chiou Yi Ho, Zuriati Ibrahim, Zalina Abu Zaid, Zulfitri ‘Azuan Mat Daud and Nor Baizura Md Yusop

    Citation: Trials 2020 21:533

    Content type: Study protocol

    Published on:

  10. Perceived high chronic stress is twice as prevalent among German general practitioners (GPs) and non-physician medical staff compared to the general population. The reasons are multi-factorial and include pati...

    Authors: Birgitta M. Weltermann, Christine Kersting, Claudia Pieper, Tanja Seifried-Dübon, Annegret Dreher, Karen Linden, Esther Rind, Claudia Ose, Karl-Heinz Jöckel, Florian Junne, Brigitte Werners, Verena Schroeder, Jean-Marie Bois, Achim Siegel, Anika Thielmann, Monika A. Rieger…

    Citation: Trials 2020 21:532

    Content type: Study protocol

    Published on:

  11. Colonic diverticular disease has been increasing in prevalence due to the rapidly aging global population, but standard treatment has not changed dramatically in recent years. Daiobotanpito (DBT; Da Huang Mu Dan ...

    Authors: Keiko Ogawa-Ochiai, Kenichi Yoshimura, Akiko Shirai, Seisho Sakai, Hideki Moriyama, Keishi Nakamura, Toshinori Murayama and Hideki Ishikawa

    Citation: Trials 2020 21:531

    Content type: Study protocol

    Published on:

  12. There are few sources of published data on intra-cluster correlation coefficients (ICCs) amongst patients with type 2 diabetes (T2D) and/or hypertension in primary care, particularly in low- and middle-income ...

    Authors: Yi Lin Lee, Yvonne Mei Fong Lim, Kian Boon Law and Sheamini Sivasampu

    Citation: Trials 2020 21:530

    Content type: Methodology

    Published on:

  13. Despite its proven efficacy in reducing recurrence and improving survival, adherence to endocrine therapy (ET) is suboptimal in women with breast cancer (BC). Health-related quality of life (HRQoL) in BC has b...

    Authors: Ariane Mamguem Kamga, Cyril Di Martino, Amelie Anota, Sophie Paget-Bailly, Charles Coutant, Patrick Arveux, Isabelle Desmoulins and Tienhan Sandrine Dabakuyo-Yonli

    Citation: Trials 2020 21:527

    Content type: Study protocol

    Published on:

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

    Authors: Nicola J. Christofides, Abigail M. Hatcher, Dumisani Rebombo, Ruari-Santiago McBride, Shehnaz Munshi, Angelica Pino, Nada Abdelatif, Dean Peacock, Jonathan Levin and Rachel K. Jewkes

    Citation: Trials 2020 21:526

    Content type: Correction

    Published on:

    The original article was published in Trials 2020 21:359

  15. Temporomandibular disorder (TMD) is a condition encompassing clinical symptoms of the temporomandibular joint, masseter muscle, and surrounding structures. Hominis placental pharmacopuncture (HPP), consisting ...

    Authors: Jongho Kim, Kyoung Sun Park, Yoon Jae Lee, Koh-Woon Kim, Jae-Heung Cho and In-Hyuk Ha

    Citation: Trials 2020 21:525

    Content type: Study protocol

    Published on:

  16. Scaled-up direct-acting antiviral (DAA) treatment of hepatitis C virus (HCV) infection among people who inject drugs (PWID) is crucial to reach the World Health Organization HCV elimination targets within 2030...

    Authors: H. Midgard, A. K. Finbråten, K. B. Malme, R. M. Berg-Pedersen, L. Tanum, I. C. Olsen, R. Bjørnestad and O. Dalgard

    Citation: Trials 2020 21:524

    Content type: Study protocol

    Published on:

  17. The KERALINK trial tests the hypothesis that corneal cross-linking (CXL) treatment reduces the progression of keratoconus in comparison to standard care in patients aged 10–16 years. This article describes the...

    Authors: Kashfia Chowdhury, Caroline J. Doré, Catey Bunce and Daniel F. P. Larkin

    Citation: Trials 2020 21:523

    Content type: Update

    Published on:

  18. Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother–infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent st...

    Authors: Claire Cardaillac, Stéphane Ploteau, Aurélie Le Thuaut, Vincent Dochez, Norbert Winer and Guillaume Ducarme

    Citation: Trials 2020 21:522

    Content type: Study protocol

    Published on:

  19. Independent of pain intensity, pain-specific distress is highly predictive of pain treatment needs, including the need for prescription opioids. Given the inherently distressing nature of chronic pain, there i...

    Authors: Maisa S. Ziadni, Abby L. Chen, Tyler Winslow, Sean C. Mackey and Beth D. Darnall

    Citation: Trials 2020 21:521

    Content type: Study protocol

    Published on:

  20. To assess the safety and therapeutic effects of allogeneic human dental pulp stem cells (DPSCs) in treating severe pneumonia caused by COVID-19.

    Authors: Qingsong Ye, Hua Wang, Xia Xia, Chenliang Zhou, Zhiming Liu, Zun-en Xia, Zhan Zhang, Yang Zhao, Jun Yehenala, Si Wang, Gangqiao Zhou, Ke Hu, Bin Wu, Chu-Tse Wu, Songling Wang and Yan He

    Citation: Trials 2020 21:520

    Content type: Letter

    Published on:

  21. Individuals affected by heart failure (HF) may present fatigue, dyspnea, respiratory muscle weakness, and sympathetic activity hyperstimulation of the myocardium, among other symptoms. Conducting cardiac rehab...

    Authors: Jéssica Costa Leite, Daniella Cunha Brandão, Simone Cristina Soares Brandão, Helen Kerlen Bastos Fuzari, Tainá Maria Vidal, Jasiel Frutuoso, Maria Inês Remígio, Bruna Thays Santana de Araújo, Shirley Lima Campos and Armele Dornelas de Andrade

    Citation: Trials 2020 21:519

    Content type: Study protocol

    Published on:

  22. Firefighters’ health is often affected by a high prevalence of obesity and cardiovascular diseases, which are common risk factors for sudden cardiac death. The aim of this study is to investigate the feasibili...

    Authors: Wing Man Ng and Kin Cheung

    Citation: Trials 2020 21:518

    Content type: Study protocol

    Published on:

  23. Many patients with poorly controlled multiple chronic conditions (MCC) also have unhealthy behaviors, mental health challenges, and unmet social needs. Medical management of MCC may have limited benefit if pat...

    Authors: Alex H. Krist, Kristen O’Loughlin, Steven H. Woolf, Roy T. Sabo, Jennifer Hinesley, Anton J. Kuzel, Bruce D. Rybarczyk, Paulette Lail Kashiri, E. Marshall Brooks, Russel E. Glasgow, Amy G. Huebschmann and Winston R. Liaw

    Citation: Trials 2020 21:517

    Content type: Study protocol

    Published on:

  24. Less invasive surfactant administration (LISA) is a way of giving surfactant without endotracheal intubation and has shown to be promising in reducing the incidence of bronchopulmonary dysplasia (BPD) in prete...

    Authors: Jiajun Zhu, Yingying Bao, Lizhong Du, Huafei Huang, Qin lv, Yejun Jiang, Yuxuan Dai, Zhijun Chen, Jingyun Shi, Yongyan Shi, Chuangzhong Yang, Hua Mei, Hong Jiang, Yanhui Sun and Xuemei Sun

    Citation: Trials 2020 21:516

    Content type: Study protocol

    Published on:

  25. This study aimed to test the feasibility and titration methods used to achieve specific blood pressure (BP) control targets in hypertensive patients of rural China.

    Authors: Xiao Huang, Lishun Liu, Yun Song, Lan Gao, Min Zhao, Huihui Bao, Xianhui Qin, Yanqing Wu, Qinghua Wu, Chonglei Bi, Aiping Yue, Chongqian Fang, Hai Ma, Yimin Cui, Genfu Tang, Ping Li…

    Citation: Trials 2020 21:515

    Content type: Study protocol

    Published on:

  26. Poor recruitment in clinical trials is well-documented. In large, multi-centre trials, communication between the coordinating centre and trial sites is essential. A commonly used communication tool is the host...

    Authors: E. J. Mitchell, P. J. Godolphin, G. Meakin and K. Sprange

    Citation: Trials 2020 21:514

    Content type: Methodology

    Published on:

  27. The aim of this randomised GCP-controlled trial is to clarify whether combination therapy with the antibiotic azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy and...

    Authors: Pradeesh Sivapalan, Charlotte Suppli Ulrik, Rasmus Dahlin Bojesen, Therese Sophie Lapperre, Josefin Viktoria Eklöf, Kjell Erik Julius Håkansson, Andrea Browatzki, Casper Tidemansen, Jon Torgny Wilcke, Julie Janner, Vibeke Gottlieb, Howraman Meteran, Celeste Porsbjerg, Birgitte Lindegaard Madsen, Mia Moberg, Lars Pedersen…

    Citation: Trials 2020 21:513

    Content type: Letter

    Published on:

  28. Non-alcoholic fatty liver disease (NAFLD) is a common chronic liver disease characterized by excessive fat accumulation in the liver. One of the underlying pathophysiological mechanisms is insulin resistance (...

    Authors: Jingjuan Xu, Ruirui Wang, Shengfu You, Lei Zhang, Peiyong Zheng, Guang Ji and Baocheng Liu

    Citation: Trials 2020 21:512

    Content type: Study protocol

    Published on:

  29. Behçet’s syndrome (BS) is a systemic inflammatory disorder of unknown etiology, and it is characterized by a wide range of potential clinical manifestations. Recent evidence suggests that the gut microbiota (G...

    Authors: Giuditta Pagliai, Monica Dinu, Claudia Fiorillo, Matteo Becatti, Silvia Turroni, Giacomo Emmi and Francesco Sofi

    Citation: Trials 2020 21:511

    Content type: Study protocol

    Published on:

  30. The global health challenge of dementia is exceptional in size, cost and impact. It is the only top ten cause of death that cannot be prevented, cured or substantially slowed, leaving disease management, careg...

    Authors: Bettina Sandgathe Husebo, Heather Allore, Wilco Achterberg, Renira Corinne Angeles, Clive Ballard, Frøydis Kristine Bruvik, Stein Erik Fæø, Marie Hidle Gedde, Eirin Hillestad, Frode Fadnes Jacobsen, Øyvind Kirkevold, Egil Kjerstad, Reidun Lisbeth Skeide Kjome, Janne Mannseth, Mala Naik, Rui Nouchi…

    Citation: Trials 2020 21:510

    Content type: Study protocol

    Published on:

  31. Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particu...

    Authors: Alejandra Paniagua-Avila, Meredith P. Fort, Russell E. Glasgow, Pablo Gulayin, Diego Hernández-Galdamez, Kristyne Mansilla, Eduardo Palacios, Ana Lucia Peralta, Dina Roche, Adolfo Rubinstein, Jiang He, Manuel Ramirez-Zea and Vilma Irazola

    Citation: Trials 2020 21:509

    Content type: Study protocol

    Published on:

  32. Self-management strategies are effective in a number of medical conditions; however, implementation studies have demonstrated adoption into clinical practice can be problematic. The process of implementation w...

    Authors: Alexandra E. Cairns, Katherine L. Tucker, Carole Crawford, Richard J. McManus and John Powell

    Citation: Trials 2020 21:508

    Content type: Research

    Published on:

  33. Failure to collect outcome data in randomised trials can result in bias and loss of statistical power. Further evaluations of strategies to increase retention are required. We assessed the effectiveness of two...

    Authors: Lucy E. Bradshaw, Alan A. Montgomery, Hywel C. Williams, Joanne R. Chalmers and Rachel H. Haines

    Citation: Trials 2020 21:529

    Content type: Research

    Published on:

  34. Patient adherence to treatment is a key determinant of outcome for healthcare interventions. Whilst non-adherence has been well evidenced in settings such as drug therapy, information regarding patient adheren...

    Authors: Gareth Davies, Daniel Yeomans, Zoe Tolkien, Irene A. Kreis, Shelley Potter, Matthew D. Gardiner, Abhilash Jain, James Henderson and Jane M. Blazeby

    Citation: Trials 2020 21:507

    Content type: Review

    Published on:

  35. To evaluate the safety of therapeutic plasma exchange (TPE) in adult patients with serious/life-threatening COVID-19 requiring intensive care unit (ICU) admission, and associated 28-day mortality. Serious and ...

    Authors: Fahad Faqihi, Abdulrahman Alharthy, Mohammed Alodat, Daood Asad, Waleed Aletreby, Demetrios J. Kutsogiannis, Peter G. Brindley and Dimitrios Karakitsos

    Citation: Trials 2020 21:506

    Content type: Letter

    Published on:

  36. A wound that does not heal in the orderly stages of the healing process or does not heal within 3 months is considered a chronic wound. Wound healing is impaired when the wound remains in the inflammatory stag...

    Authors: Inés María Comino-Sanz, María Dolores López-Franco, Begoña Castro and Pedro Luis Pancorbo-Hidalgo

    Citation: Trials 2020 21:505

    Content type: Study protocol

    Published on:

  37. To determine the efficacy of Hydroxychloroquine vs. Hydroxychloroquine + Nitazoxanide in reducing the need for invasive mechanical ventilatory support for patients with COVID-19. Hydroxychloroquine is currentl...

    Authors: José Meneses Calderón, Hugo Mendieta Zerón and Srivatsan Padmanabhan

    Citation: Trials 2020 21:504

    Content type: Letter

    Published on:

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

    Authors: Toshinari Yamashita, Norikazu Masuda, Shigehira Saji, Kazuhiro Araki, Yoshinori Ito, Toshimi Takano, Masato Takahashi, Junji Tsurutani, Kei Koizumi, Masahiro Kitada, Yasuyuki Kojima, Yasuaki Sagara, Hiroshi Tada, Tsutomu Iwasa, Takayuki Kadoya, Tsuguo Iwatani…

    Citation: Trials 2020 21:503

    Content type: Correction

    Published on:

    The original article was published in Trials 2020 21:391

  39. Interventions designed to increase the level of physical activity are crucial in the treatment of patients with musculoskeletal conditions. The psychological group-based intervention MoVo-LISA based on the Mot...

    Authors: Jiaxi Lin, Ramona Wurst, Sarah Paganini, Vivien Hohberg, Stephan Kinkel, Wiebke Göhner, Christina Ramsenthaler and Reinhard Fuchs

    Citation: Trials 2020 21:502

    Content type: Study protocol

    Published on:

  40. Female BRCA mutation carriers have an increased lifetime risk for breast and ovarian cancer compared to the general population. Women who carry this mutation have several options to deal with their cancer risk...

    Authors: A. Isselhard, M. Töpper, B. Berger-Höger, A. Steckelberg, H. Fischer, F. Vitinius, K. Beifus, J. Köberlein-Neu, R. Wiedemann, K. Rhiem, R. Schmutzler and S. Stock

    Citation: Trials 2020 21:501

    Content type: Study protocol

    Published on:

  41. The epiretinal membrane (ERM) is a degenerative condition associated with age, which can cause loss of vision and/or metamorphopsia. The treatment of symptomatic ERM involves surgical removal including a vitre...

    Authors: Jean-Baptiste Ducloyer, Juliette Ivan, Alexandra Poinas, Olivier Lebreton, Alexandre Bonissent, Paul Fossum, Christelle Volteau, Ramin Tadayoni, Catherine Creuzot-Garchet, Yannick Le Mer, Julien Perol, June Fortin, Anne Chiffoleau, Fanny Billaud, Catherine Ivan and Michel Weber

    Citation: Trials 2020 21:500

    Content type: Study protocol

    Published on:

  42. The aim of this study is to evaluate the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in hospitalized adults with severe SARS-CoV-2 infection.

    Authors: Christina M. Eckhardt, Matthew J. Cummings, Kartik N. Rajagopalan, Sarah Borden, Zachary C. Bitan, Allison Wolf, Alex Kantor, Thomas Briese, Benjamin J. Meyer, Samuel D. Jacobson, Dawn Scotto, Nischay Mishra, Neena M. Philip, Brie A. Stotler, Joseph Schwartz, Beth Shaz…

    Citation: Trials 2020 21:499

    Content type: Letter

    Published on:

  43. The primary objective is to determine the efficacy of a single dose of ivermectin, administered to low risk, non-severe COVID-19 patients in the first 48 hours after symptom onset to reduce the proportion of p...

    Authors: Carlos Chaccour, Paula Ruiz-Castillo, Mary-Ann Richardson, Gemma Moncunill, Aina Casellas, Francisco Carmona-Torre, Miriam Giráldez, Juana Schwartz Mota, José Ramón Yuste, José Ramón Azanza, Miriam Fernández, Gabriel Reina, Carlota Dobaño, Joe Brew, Belen Sadaba, Felix Hammann…

    Citation: Trials 2020 21:498

    Content type: Letter

    Published on:

  44. Intraarticular distal humeral fractures of AO/OTA type 13 C2 and C3 pose a surgical challenge despite the evolution of surgical implants and techniques. Open reduction and internal fixation (ORIF) is often pre...

    Authors: Ali Al-Hamdani, Jeppe V. Rasmussen, Kenneth Holtz and Bo S. Olsen

    Citation: Trials 2020 21:497

    Content type: Study protocol

    Published on:

  45. Diabetic foot ulcers (DFUs) are the most common cause of leg amputations and their management is extremely challenging. Despite many advances and expensive therapies, there has been little success in improving...

    Authors: Ramanjot Kaur, Catherine Tchanque-Fossuo, Kaitlyn West, Yasmin Hadian, Anthony Gallegos, Daniel Yoon, Ligia Ismailyan, Saul Schaefer, Sara E. Dahle and R. Rivkah Isseroff

    Citation: Trials 2020 21:496

    Content type: Study protocol

    Published on:

  46. Patients with severe COVID-19 often suffer from significant pulmonary fibrosis. Although the pathogenesis of pulmonary fibrosis has not been fully explained, the signal pathways and cytokines involved are very...

    Authors: Chi Zhang, Jiawen Li, Zhao Wu, He Wang, Chengli Que, Hong Zhao and Guiqiang Wang

    Citation: Trials 2020 21:495

    Content type: Letter

    Published on:

  47. Despite efforts to improve the accuracy and transparency of the design, conduct, and reporting of randomised controlled trials (RCTs), deficiencies remain. Such deficiencies contribute to significant, avoidabl...

    Authors: Barbara Clyne, Fiona Boland, Norah Murphy, Edel Murphy, Frank Moriarty, Alan Barry, Emma Wallace, Tatyana Devine, Susan M. Smith, Declan Devane, Andrew Murphy and Tom Fahey

    Citation: Trials 2020 21:494

    Content type: Research

    Published on:

  48. Prophylactic peripheral photocoagulation has been proposed to be applied to persistent, peripheral, avascular retina for retinopathy of prematurity (ROP) patients who have received an intravitreal injection of...

    Authors: Ying Yu, Jianxun Wang, Feng Chen, Wensi Chen, Nan Jiang and Daoman Xiang

    Citation: Trials 2020 21:493

    Content type: Study protocol

    Published on:

  49. The symptom severity of a substantial group of schizophrenia patients (30–40%) does not improve through pharmacotherapy with antipsychotic medication, indicating a clear need for new treatment options to impro...

    Authors: Lyliana G. Nasib, Iris E. Sommer, Inge Winter - van Rossum, Jacqueline de Vries, Shiral S. Gangadin, Priscilla P. Oomen, Gurmeet Judge, Renske E. Blom, Jurjen J. Luykx, Nico J. M. van Beveren, Natalie D. Veen, Rune A. Kroken and Erik L. Johnsen

    Citation: Trials 2020 21:492

    Content type: Study protocol

    Published on:

  50. Colchicine is a well-known drug, which has been used for years to treat a wide range of rheumatic and inflammatory disorders. It helps break the cycle of inflammation through diverse mechanisms including reduc...

    Authors: Nooshin Dalili, Alireza Kashefizadeh, Mohsen Nafar, Fatemeh Poorrezagholi, Ahmad Firouzan, Fariba Samadian, Shiva Samavat, Shadi Ziaie and Somayeh Fatemizadeh

    Citation: Trials 2020 21:489

    Content type: Letter

    Published on:

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