Early versus Later Anticoagulation for Stroke with Atrial Fibrillation

doi:10.1056/NEJMoa2303048

Randomized Controlled Trial

. 2023 Jun 29;388(26):2411-2421.

doi: 10.1056/NEJMoa2303048. Epub 2023 May 24.

Early versus Later Anticoagulation for Stroke with Atrial Fibrillation

Urs Fischer¹, Masatoshi Koga¹, Daniel Strbian¹, Mattia Branca¹, Stefanie Abend¹, Sven Trelle¹, Maurizio Paciaroni¹, Götz Thomalla¹, Patrik Michel¹, Krassen Nedeltchev¹, Leo H Bonati¹, George Ntaios¹, Thomas Gattringer¹, Else-Charlotte Sandset¹, Peter Kelly¹, Robin Lemmens¹, P N Sylaja¹, Diana Aguiar de Sousa¹, Natan M Bornstein¹, Zuzana Gdovinova¹, Takeshi Yoshimoto¹, Marjaana Tiainen¹, Helen Thomas¹, Manju Krishnan¹, Gek C Shim¹, Christoph Gumbinger¹, Jochen Vehoff¹, Liqun Zhang¹, Kosuke Matsuzono¹, Espen Kristoffersen¹, Philippe Desfontaines¹, Peter Vanacker¹, Angelika Alonso¹, Yusuke Yakushiji¹, Caterina Kulyk¹, Dimitri Hemelsoet¹, Sven Poli¹, Ana Paiva Nunes¹, Nicoletta Caracciolo¹, Peter Slade¹, Jelle Demeestere¹, Alexander Salerno¹, Markus Kneihsl¹, Timo Kahles¹, Daria Giudici¹, Kanta Tanaka¹, Silja Räty¹, Rea Hidalgo¹, David J Werring¹, Martina Göldlin¹, Marcel Arnold¹, Cecilia Ferrari¹, Seraina Beyeler¹, Christian Fung¹, Bruno J Weder¹, Turgut Tatlisumak¹, Sabine Fenzl¹, Beata Rezny-Kasprzak¹, Arsany Hakim¹, Georgia Salanti¹, Claudio Bassetti¹, Jan Gralla¹, David J Seiffge¹, Thomas Horvath¹, Jesse Dawson¹; ELAN Investigators

Collaborators, Affiliations

Collaborators

ELAN Investigators:
Azmil Abdul-Rahim, Youssif Abousleiman, Anastasia Adamou, Adedolapo Kamaldeen Adeyemi, Sylvan J Albert, Lars Alteheld, Hisanao Akiyama, Marianne Altmann, Alexander Andrea Tarnutzer, Tal Anjum, Arunkumar Annamalai, Ijaz Anwar, Markus Arnold, Mark Barber, Anne Berberich, Ingrid Olave Bersas, Rohit Bhatia, Giovanni Bianco, Manuel Bolognese, Christophe Bonvin, Victoria Borisova, David Bradley, Christina Caporale, Tim Cassidy, Carlo W Cereda, Daniel Charissé, Carla Ciobanu, Brian Clarke, Sandra Clarke, Ronan Collins, Telma Costa, Veerle De Herdt, Gian Marco De Marchis, Nicole Del Gaudio, François Delvoye, Annemie Devroye, Aneesh Dhasan, Lynn Dixon, Jeyaraj Durai Pandian, Harvey Dymond, Roni Eichel, Sapna Erat Sreedharan, Derek Esson, Anne Falcou, Simon Fandler-Höfler, Loraine Fisch, Anna Fischer, Shigeru Fujimoto, Sofia Galego, Melissa Garcia-Pons, Lukuman Gbadamosh, Luana Gentile, Maria Giulia Mosconi, Christoph Globas, Catia Gonçalves Martins, Stefan Greisenegger, Matthias Greulich, Ben Grimshaw, Vipul Gupta, German Guzman-Gutierrez, Michael Haley, Joseph Harbison, Liam Healy, Asaf Honig, Arne Hostens, Vikram Huded, Andrea M Humm, Samer Al Hussayni Husseini, Yasuyuki Iguchi, Hege Ihle-Hansen, Manabu Inoue, Thomas Iype, Zuzana Jankovicova, Mary Joan MacLeod, Georg Kägi, Bernd Kallmünzer, Efstathia Karagkiozi, Mira Katan, Katarina Klimcikova, Risa Kato, Lukas Kellermair, Lars Kellert, Dheeraj Khurana, Himanshu Koundal, Christos Krogias, Vishav Kumar, Takenobu Kunieda, Marie Lang, Ilaria Leone De Magistris, Ronen R Leker, Arthur Liesz, Caroline Loos, Kosmas Macha, Marta Magriço, Niranjan Mahajan, Miroslav Mako, Evelyn Marcelis, Rados Marian, Michael Marnane, Nicolas Martinez-Majander, João Pedro Marto, Soichiro Matsubara, Joshua Mbroh, Christine McAlpine, John J McCabe, Friedrich Medlin, Diana Melancia, Brian Menezes, Dominik Michalski, Ole Morten Rønning, Riona Mulcahy, Martin Müller, Anna Müller, Yngve Müller Seljeseth, Ioan-Paul Muresan, Darius G Nabavi, Priya Nair, Makoto Nakajima, Aumugam Nallasivan, Vivek Nambiar, Julien Niederhauser, Imelda Noone, Stefan Oberndorfer, Jens Offermann, Elisabeth Olbert, Oezguer A Onur, David Orion, Sarah Ostanek, Asterios Paliantonis, Vijaya Pamidimukkala, Tatjana Pap, Rajsrinivas Parthasarathy, Johann Pelz, Zoltan Pencz, André Peeters, Nils Peters, Waltraud Pfeilschifter, Alexander Pichler, Teresa Pinho E Melo, Mette Pøhner Skahjem, Naren Polavarapu, Svetlana Politz, Alexandros Polymeris, George Pope, Marios Psychogios, Karthika Rani, Sucharita Ray, Susanne Renaud, Daniel Richter, Susanne Riebau, Peter Ringleb, Biljana Rodic, Georg Royl, Matthieu Pierre Rutgers, Dan Ryan, João Sargento-Freitas, Takeo Sato, Anna Maija Saukkonen, Maximilian Schell, Ludwig Schelosky, Eckhard Schlemm, Daniel Schrammel, Adrian Scutelnic, Gerli Sibolt, Norbert Silimon, Jussi Sipilä, Gaia Sirimarco, Amina Sellimi, Kerry Smith, Gemma Marie Smith, Klaudia Soltesova, João André Sousa, Torstein Spetalen, Dimitre Staykov, Henning R Stetefeld, Wendy Stoop, Sharon Storton, Davide Strambo, Kristina Szabo, Fukano Takayuki, Ryota Tanaka, Danilo Toni, Alexander Vanhoorne, Isabelle Vanpanteghem, Adhiyaman Vedamurthy, Arvind Vijaysharan Sharma, Tim J Von Oertzen, Milan Vosko, Jan Vynckier, Judith Wagner, Clare Whyte, Ami Wilkinson, Alastair Wilson, Fiona Wright, Sohei Yoshimura, Laetitia Yperzeele, Andrea Zini

Affiliation

¹ From the Department of Neurology, University Hospital Basel, University of Basel, Basel (U.F., T.K.), the Department of Neurology (U.F., S.A., K.N., M.G., M.A., C. Ferrari, S.B., C.B., D.J.S., T.H.), the Support Center for Advanced Neuroimaging, Institute of Diagnostic and Interventional Neuroradiology (B.J.W.), and the Institute for Diagnostic and Interventional Neuroradiology (S.F., B.R.-K., A.H., J.G.), University Hospital Bern, and CTU Bern (M.B., S.T.), Institute of Social and Preventive Medicine (G.S.), University of Bern, Bern, the Department of Neurology, University Hospital Lausanne, University of Lausanne, Lausanne (P.M., A.S.), the Department of Neurology, Cantonal Hospital Aarau, Aarau (K.N., T.K.), the Research Department, Reha Rheinfelden, Rheinfelden (L.H.B.), and the Department of Neurology, Cantonal Hospital St. Gallen, St. Gallen (J.V.) - all in Switzerland; the Departments of Cerebrovascular Medicine (M. Koga, K.T.) and Neurology (T.Y.), National Cerebral and Cardiovascular Center, Osaka, the Division of Neurology, Department of Medicine, Jichi Medical University, Tochigi (K.M.), and the Department of Neurology, Kansai Medical University, Hirakata (Y.Y.) - all in Japan; the Department of Neurology, Helsinki University Hospital, and University of Helsinki, Helsinki (D.S., M.T., S.R.); Internal, Vascular, and Emergency Medicine, Stroke Unit, Santa Maria della Misericordia Hospital, University of Perugia, Perugia (M.P., D.G.), and the Department of Human Neurosciences, University La Sapienza, Rome (N.C.) - both in Italy; the Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg (G.T.), the Department of Neurology, Heidelberg University Hospital (C.G.), and the Department of Neurology, Medical Faculty Mannheim, University of Heidelberg (A.A.), Heidelberg, the Department of Neurology and Stroke and the Hertie Institute for Clinical Brain Research, Tübingen University, Tübingen (S.P.), and the Department of Neurosurgery, Medical Center, University of Freiburg, Freiburg (C. Fung) - all in Germany; the Department of Internal Medicine, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece (G.N.); the Department of Neurology, and the Division of Neuroradiology, Vascular and Interventional Radiology, Department of Radiology, Medical University of Graz, Graz (T.G., M. Kneihsl), and the Department of Neurology 2, Kepler University Hospital, Johannes Kepler University, Linz (C.K.) - both in Austria; the Department of Neurology, Oslo University Hospital (E.-C.S.), the Department of General Practice, University of Oslo (E.K.), and the Norwegian Air Ambulance Foundation (E.-C.S.), Oslo, and the Department of Neurology, Akershus University Hospital, Lørenskog (E.K.) - all in Norway; the Department of Neurology, Mater Misericordiae University Hospital, Dublin (P.K.); KU Leuven, Department of Neurosciences, Experimental Neurology, and the Department of Neurology, University Hospitals Leuven, Leuven (R.L., J. Demeestere), the Department of Neurology, Comprehensive Stroke Unit, CHC MontLégia Hospital, Liège (P.D.), the Department of Neurology, Algemeen Ziekenhuis Groeninge Kortrijk, Kortrijk (P.V.), the Neurovascular Center and Stroke Unit Antwerp, Antwerp University Hospital, and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (P.V.), and the Department of Neurology, Ghent University Hospital, Ghent (D.H.) - all in Belgium; Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India (P.N.S.); the Stroke Center, Lisbon Central University Hospital (D.A.S., A.P.N.) and Faculty of Medicine, University of Lisbon (D.A.S.) - both in Lisbon, Portugal; the Department of Neurology, Shaare Zedek Medical Center, Jerusalem (N.M.B.); the Department of Neurology, Faculty of Medicine, Pavol Jozef Safarik University, and University Hospital Louis Pasteur - both in Košice, Slovakia (Z.G.); Glan Clwyd Hospital, Betsi Cadwaladr University Health Board, Rhyl (H.T., R.H.), the Stroke Unit, Morriston Hospital, Swansea Bay University Health Board, Swansea (M. Krishnan, P.S.), the Stroke Department, University Hospital of North Durham, Durham (G.C.S.), the Department of Neurology, St. George's University Hospital (L.Z.), and the Stroke Research Centre, Department of Brain Repair and Rehabilitation, University College London Queen Square Institute of Neurology, University College London (D.J.W.), London, and the School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow (J. Dawson) - all in the United Kingdom; and the Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, and the Department of Neurology, Sahlgrenska University Hospital - both in Gothenburg, Sweden (T.T.).

PMID: 37222476
DOI: 10.1056/NEJMoa2303048

Free article

Randomized Controlled Trial

Early versus Later Anticoagulation for Stroke with Atrial Fibrillation

Urs Fischer et al. N Engl J Med. 2023.

Free article

. 2023 Jun 29;388(26):2411-2421.

doi: 10.1056/NEJMoa2303048. Epub 2023 May 24.

Authors

Collaborators

ELAN Investigators:
Azmil Abdul-Rahim, Youssif Abousleiman, Anastasia Adamou, Adedolapo Kamaldeen Adeyemi, Sylvan J Albert, Lars Alteheld, Hisanao Akiyama, Marianne Altmann, Alexander Andrea Tarnutzer, Tal Anjum, Arunkumar Annamalai, Ijaz Anwar, Markus Arnold, Mark Barber, Anne Berberich, Ingrid Olave Bersas, Rohit Bhatia, Giovanni Bianco, Manuel Bolognese, Christophe Bonvin, Victoria Borisova, David Bradley, Christina Caporale, Tim Cassidy, Carlo W Cereda, Daniel Charissé, Carla Ciobanu, Brian Clarke, Sandra Clarke, Ronan Collins, Telma Costa, Veerle De Herdt, Gian Marco De Marchis, Nicole Del Gaudio, François Delvoye, Annemie Devroye, Aneesh Dhasan, Lynn Dixon, Jeyaraj Durai Pandian, Harvey Dymond, Roni Eichel, Sapna Erat Sreedharan, Derek Esson, Anne Falcou, Simon Fandler-Höfler, Loraine Fisch, Anna Fischer, Shigeru Fujimoto, Sofia Galego, Melissa Garcia-Pons, Lukuman Gbadamosh, Luana Gentile, Maria Giulia Mosconi, Christoph Globas, Catia Gonçalves Martins, Stefan Greisenegger, Matthias Greulich, Ben Grimshaw, Vipul Gupta, German Guzman-Gutierrez, Michael Haley, Joseph Harbison, Liam Healy, Asaf Honig, Arne Hostens, Vikram Huded, Andrea M Humm, Samer Al Hussayni Husseini, Yasuyuki Iguchi, Hege Ihle-Hansen, Manabu Inoue, Thomas Iype, Zuzana Jankovicova, Mary Joan MacLeod, Georg Kägi, Bernd Kallmünzer, Efstathia Karagkiozi, Mira Katan, Katarina Klimcikova, Risa Kato, Lukas Kellermair, Lars Kellert, Dheeraj Khurana, Himanshu Koundal, Christos Krogias, Vishav Kumar, Takenobu Kunieda, Marie Lang, Ilaria Leone De Magistris, Ronen R Leker, Arthur Liesz, Caroline Loos, Kosmas Macha, Marta Magriço, Niranjan Mahajan, Miroslav Mako, Evelyn Marcelis, Rados Marian, Michael Marnane, Nicolas Martinez-Majander, João Pedro Marto, Soichiro Matsubara, Joshua Mbroh, Christine McAlpine, John J McCabe, Friedrich Medlin, Diana Melancia, Brian Menezes, Dominik Michalski, Ole Morten Rønning, Riona Mulcahy, Martin Müller, Anna Müller, Yngve Müller Seljeseth, Ioan-Paul Muresan, Darius G Nabavi, Priya Nair, Makoto Nakajima, Aumugam Nallasivan, Vivek Nambiar, Julien Niederhauser, Imelda Noone, Stefan Oberndorfer, Jens Offermann, Elisabeth Olbert, Oezguer A Onur, David Orion, Sarah Ostanek, Asterios Paliantonis, Vijaya Pamidimukkala, Tatjana Pap, Rajsrinivas Parthasarathy, Johann Pelz, Zoltan Pencz, André Peeters, Nils Peters, Waltraud Pfeilschifter, Alexander Pichler, Teresa Pinho E Melo, Mette Pøhner Skahjem, Naren Polavarapu, Svetlana Politz, Alexandros Polymeris, George Pope, Marios Psychogios, Karthika Rani, Sucharita Ray, Susanne Renaud, Daniel Richter, Susanne Riebau, Peter Ringleb, Biljana Rodic, Georg Royl, Matthieu Pierre Rutgers, Dan Ryan, João Sargento-Freitas, Takeo Sato, Anna Maija Saukkonen, Maximilian Schell, Ludwig Schelosky, Eckhard Schlemm, Daniel Schrammel, Adrian Scutelnic, Gerli Sibolt, Norbert Silimon, Jussi Sipilä, Gaia Sirimarco, Amina Sellimi, Kerry Smith, Gemma Marie Smith, Klaudia Soltesova, João André Sousa, Torstein Spetalen, Dimitre Staykov, Henning R Stetefeld, Wendy Stoop, Sharon Storton, Davide Strambo, Kristina Szabo, Fukano Takayuki, Ryota Tanaka, Danilo Toni, Alexander Vanhoorne, Isabelle Vanpanteghem, Adhiyaman Vedamurthy, Arvind Vijaysharan Sharma, Tim J Von Oertzen, Milan Vosko, Jan Vynckier, Judith Wagner, Clare Whyte, Ami Wilkinson, Alastair Wilson, Fiona Wright, Sohei Yoshimura, Laetitia Yperzeele, Andrea Zini

Affiliation

¹ From the Department of Neurology, University Hospital Basel, University of Basel, Basel (U.F., T.K.), the Department of Neurology (U.F., S.A., K.N., M.G., M.A., C. Ferrari, S.B., C.B., D.J.S., T.H.), the Support Center for Advanced Neuroimaging, Institute of Diagnostic and Interventional Neuroradiology (B.J.W.), and the Institute for Diagnostic and Interventional Neuroradiology (S.F., B.R.-K., A.H., J.G.), University Hospital Bern, and CTU Bern (M.B., S.T.), Institute of Social and Preventive Medicine (G.S.), University of Bern, Bern, the Department of Neurology, University Hospital Lausanne, University of Lausanne, Lausanne (P.M., A.S.), the Department of Neurology, Cantonal Hospital Aarau, Aarau (K.N., T.K.), the Research Department, Reha Rheinfelden, Rheinfelden (L.H.B.), and the Department of Neurology, Cantonal Hospital St. Gallen, St. Gallen (J.V.) - all in Switzerland; the Departments of Cerebrovascular Medicine (M. Koga, K.T.) and Neurology (T.Y.), National Cerebral and Cardiovascular Center, Osaka, the Division of Neurology, Department of Medicine, Jichi Medical University, Tochigi (K.M.), and the Department of Neurology, Kansai Medical University, Hirakata (Y.Y.) - all in Japan; the Department of Neurology, Helsinki University Hospital, and University of Helsinki, Helsinki (D.S., M.T., S.R.); Internal, Vascular, and Emergency Medicine, Stroke Unit, Santa Maria della Misericordia Hospital, University of Perugia, Perugia (M.P., D.G.), and the Department of Human Neurosciences, University La Sapienza, Rome (N.C.) - both in Italy; the Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg (G.T.), the Department of Neurology, Heidelberg University Hospital (C.G.), and the Department of Neurology, Medical Faculty Mannheim, University of Heidelberg (A.A.), Heidelberg, the Department of Neurology and Stroke and the Hertie Institute for Clinical Brain Research, Tübingen University, Tübingen (S.P.), and the Department of Neurosurgery, Medical Center, University of Freiburg, Freiburg (C. Fung) - all in Germany; the Department of Internal Medicine, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece (G.N.); the Department of Neurology, and the Division of Neuroradiology, Vascular and Interventional Radiology, Department of Radiology, Medical University of Graz, Graz (T.G., M. Kneihsl), and the Department of Neurology 2, Kepler University Hospital, Johannes Kepler University, Linz (C.K.) - both in Austria; the Department of Neurology, Oslo University Hospital (E.-C.S.), the Department of General Practice, University of Oslo (E.K.), and the Norwegian Air Ambulance Foundation (E.-C.S.), Oslo, and the Department of Neurology, Akershus University Hospital, Lørenskog (E.K.) - all in Norway; the Department of Neurology, Mater Misericordiae University Hospital, Dublin (P.K.); KU Leuven, Department of Neurosciences, Experimental Neurology, and the Department of Neurology, University Hospitals Leuven, Leuven (R.L., J. Demeestere), the Department of Neurology, Comprehensive Stroke Unit, CHC MontLégia Hospital, Liège (P.D.), the Department of Neurology, Algemeen Ziekenhuis Groeninge Kortrijk, Kortrijk (P.V.), the Neurovascular Center and Stroke Unit Antwerp, Antwerp University Hospital, and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (P.V.), and the Department of Neurology, Ghent University Hospital, Ghent (D.H.) - all in Belgium; Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India (P.N.S.); the Stroke Center, Lisbon Central University Hospital (D.A.S., A.P.N.) and Faculty of Medicine, University of Lisbon (D.A.S.) - both in Lisbon, Portugal; the Department of Neurology, Shaare Zedek Medical Center, Jerusalem (N.M.B.); the Department of Neurology, Faculty of Medicine, Pavol Jozef Safarik University, and University Hospital Louis Pasteur - both in Košice, Slovakia (Z.G.); Glan Clwyd Hospital, Betsi Cadwaladr University Health Board, Rhyl (H.T., R.H.), the Stroke Unit, Morriston Hospital, Swansea Bay University Health Board, Swansea (M. Krishnan, P.S.), the Stroke Department, University Hospital of North Durham, Durham (G.C.S.), the Department of Neurology, St. George's University Hospital (L.Z.), and the Stroke Research Centre, Department of Brain Repair and Rehabilitation, University College London Queen Square Institute of Neurology, University College London (D.J.W.), London, and the School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow (J. Dawson) - all in the United Kingdom; and the Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, and the Department of Neurology, Sahlgrenska University Hospital - both in Gothenburg, Sweden (T.T.).

PMID: 37222476
DOI: 10.1056/NEJMoa2303048

Abstract

Background: The effect of early as compared with later initiation of direct oral anticoagulants (DOACs) in persons with atrial fibrillation who have had an acute ischemic stroke is unclear.

Methods: We performed an investigator-initiated, open-label trial at 103 sites in 15 countries. Participants were randomly assigned in a 1:1 ratio to early anticoagulation (within 48 hours after a minor or moderate stroke or on day 6 or 7 after a major stroke) or later anticoagulation (day 3 or 4 after a minor stroke, day 6 or 7 after a moderate stroke, or day 12, 13, or 14 after a major stroke). Assessors were unaware of the trial-group assignments. The primary outcome was a composite of recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic intracranial hemorrhage, or vascular death within 30 days after randomization. Secondary outcomes included the components of the composite primary outcome at 30 and 90 days.

Results: Of 2013 participants (37% with minor stroke, 40% with moderate stroke, and 23% with major stroke), 1006 were assigned to early anticoagulation and 1007 to later anticoagulation. A primary-outcome event occurred in 29 participants (2.9%) in the early-treatment group and 41 participants (4.1%) in the later-treatment group (risk difference, -1.18 percentage points; 95% confidence interval [CI], -2.84 to 0.47) by 30 days. Recurrent ischemic stroke occurred in 14 participants (1.4%) in the early-treatment group and 25 participants (2.5%) in the later-treatment group (odds ratio, 0.57; 95% CI, 0.29 to 1.07) by 30 days and in 18 participants (1.9%) and 30 participants (3.1%), respectively, by 90 days (odds ratio, 0.60; 95% CI, 0.33 to 1.06). Symptomatic intracranial hemorrhage occurred in 2 participants (0.2%) in both groups by 30 days.

Conclusions: In this trial, the incidence of recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic intracranial hemorrhage, or vascular death at 30 days was estimated to range from 2.8 percentage points lower to 0.5 percentage points higher (based on the 95% confidence interval) with early than with later use of DOACs. (Funded by the Swiss National Science Foundation and others; ELAN ClinicalTrials.gov number, NCT03148457.).

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Early versus Later Anticoagulation for Stroke with Atrial Fibrillation

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Early versus Later Anticoagulation for Stroke with Atrial Fibrillation

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