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Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial.

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Title: Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial.
Authors: Trøseid M; Section for Clinical Immunology and Infectious Diseases, Oslo University Hospital, Oslo, Norway. marius.troseid@medisin.uio.no.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway. marius.troseid@medisin.uio.no., Arribas JR; Infectious Diseases Unit, Internal Medicine Department, La Paz University Hospital, IdiPAZ, Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Madrid, Spain., Assoumou L; Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie Et de Santé Publique (IPLESP), Paris, France., Holten AR; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Acute Medicine, Oslo University Hospital, Oslo, Norway., Poissy J; Lille University, Lille, France/CHU Lille - Hôpital Roger Salengro, Lille, France.; L'Institut National de La Santé Et de La Recherche Médicale (Inserm), Paris, France., Terzić V; Maladies Infectieuses Emergentes, 75015, Paris, France.; Institut National de La Santé Et de La Recherche Médicale, INSERM, 75013, Paris, France., Mazzaferri F; Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, Verona, Italy., Baño JR; Department of Medicine, Virgen Macarena University Hospital, Seville, Spain.; University of Sevilla and Biomedicines Institute of Seville (IBiS)/CSIC, Seville, Spain.; CIBERINFEC, Instituto de Salud Carlos III, Madrid, Spain., Eustace J; University College Cork, Cork, Ireland., Hites M; Brussels University Hospital-Erasme, Brussels, Belgium.; Université Libre de Bruxelles, Brussels, Belgium., Joannidis M; Medical University Innsbruck, Innsbruck, Austria., Paiva JA; Intensive Care Medicine Department, Centro Hospitalar Universitário Sao Joao, Porto, Portugal.; Faculty of Medicine, University of Porto, Porto, Portugal., Reuter J; Centre Hospitalier de Luxembourg, Service de Réanimation-Soins Intensifs, 1210, Luxembourg, Luxembourg., Püntmann I; Institute of Pharmacology, Hospital Group Gesundheit Nord gGmbH, Bremen, Germany., Patrick-Brown TDJH; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Oslo, Norway., Westerheim E; Section for Monitoring, Clinical Trial Unit (CTU), Oslo University Hospital, Oslo, Norway., Nezvalova-Henriksen K; Department of Haematology, Oslo University Hospital and Oslo Hospital Pharmacy, Oslo, Norway., Beniguel L; Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie Et de Santé Publique (IPLESP), Paris, France., Dahl TB; Research Institute for Internal Medicine, Oslo University Hospital, Oslo, Norway.; Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway., Bouscambert M; Laboratoire de Virologie, Institut Des Agents Infectieux de Lyon, Centre National de Reference Des Virus Des Infections Respiratoires France Sud, Hospices Civils de Lyon, 69317, Lyon, France., Halanova M; Department of Epidemiology, Faculty of Medicine, Pavol Jozef Šafárik University in Košice, Košice, Slovakia., Péterfi Z; 1St Department of Internal Medicine, Division of Infectology, University of Pécs, Pécs, Hungary., Tsiodras S; National and Kapodistrian University of Athens, Athens, Greece.; University Hospital of Athens Attikon, Athens, Greece., Rezek M; St. Anne University Hospital, Brno, Czech Republic., Briel M; Swiss Clinical Trial Organisation and Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland., Ünal S; Hacettepe University Hospital, Ankara, Turkey., Schlegel M; Department of Anesthesiology and Intensive Care Medicine, Klinikum Rechts Der Isar, Technische Universität München, Munich, Germany., Ader F; Hospices Civils de Lyon, Département Des Maladies Infectieuses Et Tropicales, 69004, Lyon, France.; Centre International de Recherche en Infectiologie (CIRI), Inserm 1111, Université Claude Bernard Lyon 1, CNRS, UMR5308, École Normale Supérieure de Lyon, Univ Lyon, 69007, Lyon, France., Lacombe K; Sorbonne Université, Institut Pierre-Louis d'Épidemiologie Et de Santé Publique, INSERM, 75013, Paris, France.; APHP, Hôpital Saint-Antoine, Service de Maladies Infectieuses Et Tropicales, 75012, Paris, France., Amdal CD; Research support service and Department of Oncology, Oslo University Hospital, Oslo, Norway., Rodrigues S; Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie Et de Santé Publique (IPLESP), Paris, France., Tonby K; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Deptartment of Infectious Diseases, Oslo University Hospital, Oslo, Norway., Gaudet A; Critical Care Center, Department of Intensive Care Medicine, CHU Lille, 59000, Lille, France.; Univ. Lille, CNRS, Inserm, CHU Lille, Institut Pasteur de Lille, U1019-UMR9017-CIIL-Centre d'Infection Et d'Immunité de Lille, 59000, Lille, France., Heggelund L; Medical Department, Drammen Hospital, Vestre Viken Hospital Trust, Drammen, Norway.; Department of Clinical Science, University of Bergen, Bergen, Norway., Mootien J; Service, de Réanimation Médiale, GHRMSA Hopital Emile Muller, Mulhouse, France., Johannessen A; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Infectious Diseases, Vestfold Hospital Trust, Tønsberg, Norway., Møller JH; Department of Intensive Care Medicine, Stavanger University Hospital, Stavanger, Norway., Pollan BD; Infectious Diseases Unit, Internal Medicine Department, La Paz University Hospital, Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), IdiPAZ, Madrid, Spain., Tveita AA; Department of Medicine, Bærum Hospital, Vestre Viken, Bærum, Norway., Kildal AB; Department of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø, Norway., Richard JC; Service de Médecine Intensive-Réanimation, Hôpital de La Croix - Rousse - HCL, Lyon, France.; CREATIS INSERM U1206-CNRS UMR 5220, Lyon, France., Dalgard O; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Akershus University Hospital, Lørenskog, Norway., Simensen VC; Division of Health Services, Department of Global Health, Norwegian Institute of Public Health, Oslo, Norway., Baldé A; Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie Et de Santé Publique (IPLESP), Paris, France., de Gastines L; Maladies Infectieuses Emergentes, 75015, Paris, France.; Institut National de La Santé Et de La Recherche Médicale, INSERM, 75013, Paris, France., Del Álamo M; ECRIN, Paris, France., Aydin B; Department of Immunology, Oslo University Hospital, Oslo, Norway., Lund-Johansen F; Department of Immunology, Oslo University Hospital, Oslo, Norway., Trabaud MA; Laboratoire de Virologie, Institut Des Agents Infectieux de Lyon, Centre National de Reference Des Virus Respiratoires France Sud, 69317, Hospices Civils de LyonLyon, France., Diallo A; Maladies Infectieuses Emergentes, 75015, Paris, France.; Institut National de La Santé Et de La Recherche Médicale, INSERM, 75013, Paris, France., Halvorsen B; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Research Institute of Internal Medicine, Oslo University Hospital, Oslo, Norway., Røttingen JA; Norwegian Institute of Public Health, Oslo, Norway., Tacconelli E; Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.; Verona University Hospital, Verona, Italy., Yazdanpanah Y; Université de Paris, IAME, INSERM, 75018, Paris, France.; AP-HP, Hôpital Bichat, Service de Maladies Infectieuses Et Tropicales, 75018, Paris, France., Olsen IC; Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway., Costagliola D; Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie Et de Santé Publique (IPLESP), Paris, France.
Corporate Authors: EU SolidAct study group
Source: Critical care (London, England) [Crit Care] 2023 Jan 10; Vol. 27 (1), pp. 9. Date of Electronic Publication: 2023 Jan 10.
Publication Type: Randomized Controlled Trial; Multicenter Study; Clinical Trial, Phase III; Journal Article
Journal Info: Publisher: BioMed Central Ltd Country of Publication: England NLM ID: 9801902 Publication Model: Electronic Cited Medium: Internet ISSN: 1466-609X (Electronic) Linking ISSN: 13648535 NLM ISO Abbreviation: Crit Care Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial.
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  Data: <searchLink fieldCode="AU" term="%22Trøseid+M%22">Trøseid M</searchLink>; Section for Clinical Immunology and Infectious Diseases, Oslo University Hospital, Oslo, Norway. marius.troseid@medisin.uio.no.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway. marius.troseid@medisin.uio.no.<br /><searchLink fieldCode="AU" term="%22Arribas+JR%22">Arribas JR</searchLink>; Infectious Diseases Unit, Internal Medicine Department, La Paz University Hospital, IdiPAZ, Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Assoumou+L%22">Assoumou L</searchLink>; Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie Et de Santé Publique (IPLESP), Paris, France.<br /><searchLink fieldCode="AU" term="%22Holten+AR%22">Holten AR</searchLink>; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Acute Medicine, Oslo University Hospital, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Poissy+J%22">Poissy J</searchLink>; Lille University, Lille, France/CHU Lille - Hôpital Roger Salengro, Lille, France.; L'Institut National de La Santé Et de La Recherche Médicale (Inserm), Paris, France.<br /><searchLink fieldCode="AU" term="%22Terzić+V%22">Terzić V</searchLink>; Maladies Infectieuses Emergentes, 75015, Paris, France.; Institut National de La Santé Et de La Recherche Médicale, INSERM, 75013, Paris, France.<br /><searchLink fieldCode="AU" term="%22Mazzaferri+F%22">Mazzaferri F</searchLink>; Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.<br /><searchLink fieldCode="AU" term="%22Baño+JR%22">Baño JR</searchLink>; Department of Medicine, Virgen Macarena University Hospital, Seville, Spain.; University of Sevilla and Biomedicines Institute of Seville (IBiS)/CSIC, Seville, Spain.; CIBERINFEC, Instituto de Salud Carlos III, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Eustace+J%22">Eustace J</searchLink>; University College Cork, Cork, Ireland.<br /><searchLink fieldCode="AU" term="%22Hites+M%22">Hites M</searchLink>; Brussels University Hospital-Erasme, Brussels, Belgium.; Université Libre de Bruxelles, Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22Joannidis+M%22">Joannidis M</searchLink>; Medical University Innsbruck, Innsbruck, Austria.<br /><searchLink fieldCode="AU" term="%22Paiva+JA%22">Paiva JA</searchLink>; Intensive Care Medicine Department, Centro Hospitalar Universitário Sao Joao, Porto, Portugal.; Faculty of Medicine, University of Porto, Porto, Portugal.<br /><searchLink fieldCode="AU" term="%22Reuter+J%22">Reuter J</searchLink>; Centre Hospitalier de Luxembourg, Service de Réanimation-Soins Intensifs, 1210, Luxembourg, Luxembourg.<br /><searchLink fieldCode="AU" term="%22Püntmann+I%22">Püntmann I</searchLink>; Institute of Pharmacology, Hospital Group Gesundheit Nord gGmbH, Bremen, Germany.<br /><searchLink fieldCode="AU" term="%22Patrick-Brown+TDJH%22">Patrick-Brown TDJH</searchLink>; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Westerheim+E%22">Westerheim E</searchLink>; Section for Monitoring, Clinical Trial Unit (CTU), Oslo University Hospital, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Nezvalova-Henriksen+K%22">Nezvalova-Henriksen K</searchLink>; Department of Haematology, Oslo University Hospital and Oslo Hospital Pharmacy, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Beniguel+L%22">Beniguel L</searchLink>; Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie Et de Santé Publique (IPLESP), Paris, France.<br /><searchLink fieldCode="AU" term="%22Dahl+TB%22">Dahl TB</searchLink>; Research Institute for Internal Medicine, Oslo University Hospital, Oslo, Norway.; Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Bouscambert+M%22">Bouscambert M</searchLink>; Laboratoire de Virologie, Institut Des Agents Infectieux de Lyon, Centre National de Reference Des Virus Des Infections Respiratoires France Sud, Hospices Civils de Lyon, 69317, Lyon, France.<br /><searchLink fieldCode="AU" term="%22Halanova+M%22">Halanova M</searchLink>; 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Department of Anesthesiology and Intensive Care Medicine, Klinikum Rechts Der Isar, Technische Universität München, Munich, Germany.<br /><searchLink fieldCode="AU" term="%22Ader+F%22">Ader F</searchLink>; Hospices Civils de Lyon, Département Des Maladies Infectieuses Et Tropicales, 69004, Lyon, France.; Centre International de Recherche en Infectiologie (CIRI), Inserm 1111, Université Claude Bernard Lyon 1, CNRS, UMR5308, École Normale Supérieure de Lyon, Univ Lyon, 69007, Lyon, France.<br /><searchLink fieldCode="AU" term="%22Lacombe+K%22">Lacombe K</searchLink>; Sorbonne Université, Institut Pierre-Louis d'Épidemiologie Et de Santé Publique, INSERM, 75013, Paris, France.; APHP, Hôpital Saint-Antoine, Service de Maladies Infectieuses Et Tropicales, 75012, Paris, France.<br /><searchLink fieldCode="AU" term="%22Amdal+CD%22">Amdal CD</searchLink>; Research support service and Department of Oncology, Oslo University Hospital, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Rodrigues+S%22">Rodrigues S</searchLink>; Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie Et de Santé Publique (IPLESP), Paris, France.<br /><searchLink fieldCode="AU" term="%22Tonby+K%22">Tonby K</searchLink>; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Deptartment of Infectious Diseases, Oslo University Hospital, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Gaudet+A%22">Gaudet A</searchLink>; Critical Care Center, Department of Intensive Care Medicine, CHU Lille, 59000, Lille, France.; Univ. Lille, CNRS, Inserm, CHU Lille, Institut Pasteur de Lille, U1019-UMR9017-CIIL-Centre d'Infection Et d'Immunité de Lille, 59000, Lille, France.<br /><searchLink fieldCode="AU" term="%22Heggelund+L%22">Heggelund L</searchLink>; Medical Department, Drammen Hospital, Vestre Viken Hospital Trust, Drammen, Norway.; Department of Clinical Science, University of Bergen, Bergen, Norway.<br /><searchLink fieldCode="AU" term="%22Mootien+J%22">Mootien J</searchLink>; Service, de Réanimation Médiale, GHRMSA Hopital Emile Muller, Mulhouse, France.<br /><searchLink fieldCode="AU" term="%22Johannessen+A%22">Johannessen A</searchLink>; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Infectious Diseases, Vestfold Hospital Trust, Tønsberg, Norway.<br /><searchLink fieldCode="AU" term="%22Møller+JH%22">Møller JH</searchLink>; Department of Intensive Care Medicine, Stavanger University Hospital, Stavanger, Norway.<br /><searchLink fieldCode="AU" term="%22Pollan+BD%22">Pollan BD</searchLink>; Infectious Diseases Unit, Internal Medicine Department, La Paz University Hospital, Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), IdiPAZ, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Tveita+AA%22">Tveita AA</searchLink>; Department of Medicine, Bærum Hospital, Vestre Viken, Bærum, Norway.<br /><searchLink fieldCode="AU" term="%22Kildal+AB%22">Kildal AB</searchLink>; Department of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø, Norway.<br /><searchLink fieldCode="AU" term="%22Richard+JC%22">Richard JC</searchLink>; Service de Médecine Intensive-Réanimation, Hôpital de La Croix - Rousse - HCL, Lyon, France.; CREATIS INSERM U1206-CNRS UMR 5220, Lyon, France.<br /><searchLink fieldCode="AU" term="%22Dalgard+O%22">Dalgard O</searchLink>; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Akershus University Hospital, Lørenskog, Norway.<br /><searchLink fieldCode="AU" term="%22Simensen+VC%22">Simensen VC</searchLink>; Division of Health Services, Department of Global Health, Norwegian Institute of Public Health, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Baldé+A%22">Baldé A</searchLink>; Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie Et de Santé Publique (IPLESP), Paris, France.<br /><searchLink fieldCode="AU" term="%22de+Gastines+L%22">de Gastines L</searchLink>; Maladies Infectieuses Emergentes, 75015, Paris, France.; Institut National de La Santé Et de La Recherche Médicale, INSERM, 75013, Paris, France.<br /><searchLink fieldCode="AU" term="%22Del+Álamo+M%22">Del Álamo M</searchLink>; ECRIN, Paris, France.<br /><searchLink fieldCode="AU" term="%22Aydin+B%22">Aydin B</searchLink>; Department of Immunology, Oslo University Hospital, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Lund-Johansen+F%22">Lund-Johansen F</searchLink>; Department of Immunology, Oslo University Hospital, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Trabaud+MA%22">Trabaud MA</searchLink>; Laboratoire de Virologie, Institut Des Agents Infectieux de Lyon, Centre National de Reference Des Virus Respiratoires France Sud, 69317, Hospices Civils de LyonLyon, France.<br /><searchLink fieldCode="AU" term="%22Diallo+A%22">Diallo A</searchLink>; Maladies Infectieuses Emergentes, 75015, Paris, France.; Institut National de La Santé Et de La Recherche Médicale, INSERM, 75013, Paris, France.<br /><searchLink fieldCode="AU" term="%22Halvorsen+B%22">Halvorsen B</searchLink>; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Research Institute of Internal Medicine, Oslo University Hospital, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Røttingen+JA%22">Røttingen JA</searchLink>; Norwegian Institute of Public Health, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Tacconelli+E%22">Tacconelli E</searchLink>; Division of Infectious Diseases, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.; Verona University Hospital, Verona, Italy.<br /><searchLink fieldCode="AU" term="%22Yazdanpanah+Y%22">Yazdanpanah Y</searchLink>; Université de Paris, IAME, INSERM, 75018, Paris, France.; AP-HP, Hôpital Bichat, Service de Maladies Infectieuses Et Tropicales, 75018, Paris, France.<br /><searchLink fieldCode="AU" term="%22Olsen+IC%22">Olsen IC</searchLink>; Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Costagliola+D%22">Costagliola D</searchLink>; Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie Et de Santé Publique (IPLESP), Paris, France.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22BioMed+Central+Ltd%22">BioMed Central Ltd </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>9801902 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1466-609X (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2213648535%22">13648535 </searchLink><i>NLM ISO Abbreviation: </i>Crit Care <i>Subsets: </i>MEDLINE
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      – TitleFull: Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial.
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            NameFull: Rodrigues S
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            NameFull: Tonby K
      – PersonEntity:
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            NameFull: Gaudet A
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            NameFull: Heggelund L
      – PersonEntity:
          Name:
            NameFull: Mootien J
      – PersonEntity:
          Name:
            NameFull: Johannessen A
      – PersonEntity:
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            NameFull: Møller JH
      – PersonEntity:
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            NameFull: Pollan BD
      – PersonEntity:
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            NameFull: Tveita AA
      – PersonEntity:
          Name:
            NameFull: Kildal AB
      – PersonEntity:
          Name:
            NameFull: Richard JC
      – PersonEntity:
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            NameFull: Dalgard O
      – PersonEntity:
          Name:
            NameFull: Simensen VC
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            NameFull: Olsen IC
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      – BibEntity:
          Dates:
            – D: 10
              M: 01
              Text: 2023 Jan 10
              Type: published
              Y: 2023
          Identifiers:
            – Type: issn-electronic
              Value: 1466-609X
          Numbering:
            – Type: volume
              Value: 27
            – Type: issue
              Value: 1
          Titles:
            – TitleFull: Critical care (London, England)
              Type: main
ResultId 1