Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial.
Identifieur interne : 000065 ( PubMed/Corpus ); précédent : 000064; suivant : 000066Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial.
Auteurs : Werner Poewe ; Pierre Burbaud ; Giovanni Castelnovo ; Wolfgang H. Jost ; Andres O. Ceballos-Baumann ; Marta Banach ; Anna Potulska-Chromik ; Joaquim J. Ferreira ; Katalin Bihari ; Edvard Ehler ; Martin Bares ; Lyudmyla A. Dzyak ; Anna N. Belova ; Emmanuel Pham ; Wenzhong Jerry Liu ; Philippe PicautSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2016.
Abstract
Approved botulinum toxin A products require reconstitution. AbobotulinumtoxinA solution for injection is a ready-to-use liquid formulation of abobotulinumtoxinA.
DOI: 10.1002/mds.26760
PubMed: 27653448
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial.</title><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation><nlm:affiliation>Department of Neurology, Innsbruck Medical University/University Hospital, Innsbruck, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Burbaud, Pierre" sort="Burbaud, Pierre" uniqKey="Burbaud P" first="Pierre" last="Burbaud">Pierre Burbaud</name><affiliation><nlm:affiliation>Department of Clinical Neurophysiology, CHU de Bordeaux, Bordeaux, France.</nlm:affiliation></affiliation></author><author><name sortKey="Castelnovo, Giovanni" sort="Castelnovo, Giovanni" uniqKey="Castelnovo G" first="Giovanni" last="Castelnovo">Giovanni Castelnovo</name><affiliation><nlm:affiliation>Department of Neurology, University Hospital Caremeau, Nimes, France.</nlm:affiliation></affiliation></author><author><name sortKey="Jost, Wolfgang H" sort="Jost, Wolfgang H" uniqKey="Jost W" first="Wolfgang H" last="Jost">Wolfgang H. Jost</name><affiliation><nlm:affiliation>Department of Neurology, University of Freiburg, Freiburg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Ceballos Baumann, Andres O" sort="Ceballos Baumann, Andres O" uniqKey="Ceballos Baumann A" first="Andres O" last="Ceballos-Baumann">Andres O. Ceballos-Baumann</name><affiliation><nlm:affiliation>Schön Klinik München Schwabing, Department of Neurology, Technische Universität München, München, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Banach, Marta" sort="Banach, Marta" uniqKey="Banach M" first="Marta" last="Banach">Marta Banach</name><affiliation><nlm:affiliation>Department of Neurology, Jagiellonian University Medical College, Kraków, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Potulska Chromik, Anna" sort="Potulska Chromik, Anna" uniqKey="Potulska Chromik A" first="Anna" last="Potulska-Chromik">Anna Potulska-Chromik</name><affiliation><nlm:affiliation>Department of Neurology, Medical University of Warsaw, Warsaw, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Ferreira, Joaquim J" sort="Ferreira, Joaquim J" uniqKey="Ferreira J" first="Joaquim J" last="Ferreira">Joaquim J. Ferreira</name><affiliation><nlm:affiliation>Clinical Pharmacology Unit, Instituto de Medicina Molecular, Faculty of Medicine, University of Lisbon, Lisbon, Portugal.</nlm:affiliation></affiliation></author><author><name sortKey="Bihari, Katalin" sort="Bihari, Katalin" uniqKey="Bihari K" first="Katalin" last="Bihari">Katalin Bihari</name><affiliation><nlm:affiliation>National Institute of Clinical Neurosciences, Budapest, Hungary.</nlm:affiliation></affiliation></author><author><name sortKey="Ehler, Edvard" sort="Ehler, Edvard" uniqKey="Ehler E" first="Edvard" last="Ehler">Edvard Ehler</name><affiliation><nlm:affiliation>Department of Neurology, County Hospital Pardubice, Pardubice, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Bares, Martin" sort="Bares, Martin" uniqKey="Bares M" first="Martin" last="Bares">Martin Bares</name><affiliation><nlm:affiliation>1st Department of Neurology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Dzyak, Lyudmyla A" sort="Dzyak, Lyudmyla A" uniqKey="Dzyak L" first="Lyudmyla A" last="Dzyak">Lyudmyla A. Dzyak</name><affiliation><nlm:affiliation>Dnipropetrovsk State Medical Academy, Dnipropetrovsk Regional Clinical Hospital Mechnykov, Mechnykov, Ukraine.</nlm:affiliation></affiliation></author><author><name sortKey="Belova, Anna N" sort="Belova, Anna N" uniqKey="Belova A" first="Anna N" last="Belova">Anna N. Belova</name><affiliation><nlm:affiliation>Research Institute of Traumatology and Orthopaedics, Nizhnyi Novgorod, Russia.</nlm:affiliation></affiliation></author><author><name sortKey="Pham, Emmanuel" sort="Pham, Emmanuel" uniqKey="Pham E" first="Emmanuel" last="Pham">Emmanuel Pham</name><affiliation><nlm:affiliation>Ipsen Innovation, Les Ulis, France.</nlm:affiliation></affiliation></author><author><name sortKey="Liu, Wenzhong Jerry" sort="Liu, Wenzhong Jerry" uniqKey="Liu W" first="Wenzhong Jerry" last="Liu">Wenzhong Jerry Liu</name><affiliation><nlm:affiliation>Ipsen Biopharmaceuticals Inc, Basking Ridge, New Jersey, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Picaut, Philippe" sort="Picaut, Philippe" uniqKey="Picaut P" first="Philippe" last="Picaut">Philippe Picaut</name><affiliation><nlm:affiliation>Research Institute of Traumatology and Orthopaedics, Nizhnyi Novgorod, Russia.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:27653448</idno><idno type="pmid">27653448</idno><idno type="doi">10.1002/mds.26760</idno><idno type="wicri:Area/PubMed/Corpus">000065</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000065</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial.</title><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation><nlm:affiliation>Department of Neurology, Innsbruck Medical University/University Hospital, Innsbruck, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Burbaud, Pierre" sort="Burbaud, Pierre" uniqKey="Burbaud P" first="Pierre" last="Burbaud">Pierre Burbaud</name><affiliation><nlm:affiliation>Department of Clinical Neurophysiology, CHU de Bordeaux, Bordeaux, France.</nlm:affiliation></affiliation></author><author><name sortKey="Castelnovo, Giovanni" sort="Castelnovo, Giovanni" uniqKey="Castelnovo G" first="Giovanni" last="Castelnovo">Giovanni Castelnovo</name><affiliation><nlm:affiliation>Department of Neurology, University Hospital Caremeau, Nimes, France.</nlm:affiliation></affiliation></author><author><name sortKey="Jost, Wolfgang H" sort="Jost, Wolfgang H" uniqKey="Jost W" first="Wolfgang H" last="Jost">Wolfgang H. Jost</name><affiliation><nlm:affiliation>Department of Neurology, University of Freiburg, Freiburg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Ceballos Baumann, Andres O" sort="Ceballos Baumann, Andres O" uniqKey="Ceballos Baumann A" first="Andres O" last="Ceballos-Baumann">Andres O. Ceballos-Baumann</name><affiliation><nlm:affiliation>Schön Klinik München Schwabing, Department of Neurology, Technische Universität München, München, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Banach, Marta" sort="Banach, Marta" uniqKey="Banach M" first="Marta" last="Banach">Marta Banach</name><affiliation><nlm:affiliation>Department of Neurology, Jagiellonian University Medical College, Kraków, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Potulska Chromik, Anna" sort="Potulska Chromik, Anna" uniqKey="Potulska Chromik A" first="Anna" last="Potulska-Chromik">Anna Potulska-Chromik</name><affiliation><nlm:affiliation>Department of Neurology, Medical University of Warsaw, Warsaw, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Ferreira, Joaquim J" sort="Ferreira, Joaquim J" uniqKey="Ferreira J" first="Joaquim J" last="Ferreira">Joaquim J. Ferreira</name><affiliation><nlm:affiliation>Clinical Pharmacology Unit, Instituto de Medicina Molecular, Faculty of Medicine, University of Lisbon, Lisbon, Portugal.</nlm:affiliation></affiliation></author><author><name sortKey="Bihari, Katalin" sort="Bihari, Katalin" uniqKey="Bihari K" first="Katalin" last="Bihari">Katalin Bihari</name><affiliation><nlm:affiliation>National Institute of Clinical Neurosciences, Budapest, Hungary.</nlm:affiliation></affiliation></author><author><name sortKey="Ehler, Edvard" sort="Ehler, Edvard" uniqKey="Ehler E" first="Edvard" last="Ehler">Edvard Ehler</name><affiliation><nlm:affiliation>Department of Neurology, County Hospital Pardubice, Pardubice, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Bares, Martin" sort="Bares, Martin" uniqKey="Bares M" first="Martin" last="Bares">Martin Bares</name><affiliation><nlm:affiliation>1st Department of Neurology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Dzyak, Lyudmyla A" sort="Dzyak, Lyudmyla A" uniqKey="Dzyak L" first="Lyudmyla A" last="Dzyak">Lyudmyla A. Dzyak</name><affiliation><nlm:affiliation>Dnipropetrovsk State Medical Academy, Dnipropetrovsk Regional Clinical Hospital Mechnykov, Mechnykov, Ukraine.</nlm:affiliation></affiliation></author><author><name sortKey="Belova, Anna N" sort="Belova, Anna N" uniqKey="Belova A" first="Anna N" last="Belova">Anna N. Belova</name><affiliation><nlm:affiliation>Research Institute of Traumatology and Orthopaedics, Nizhnyi Novgorod, Russia.</nlm:affiliation></affiliation></author><author><name sortKey="Pham, Emmanuel" sort="Pham, Emmanuel" uniqKey="Pham E" first="Emmanuel" last="Pham">Emmanuel Pham</name><affiliation><nlm:affiliation>Ipsen Innovation, Les Ulis, France.</nlm:affiliation></affiliation></author><author><name sortKey="Liu, Wenzhong Jerry" sort="Liu, Wenzhong Jerry" uniqKey="Liu W" first="Wenzhong Jerry" last="Liu">Wenzhong Jerry Liu</name><affiliation><nlm:affiliation>Ipsen Biopharmaceuticals Inc, Basking Ridge, New Jersey, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Picaut, Philippe" sort="Picaut, Philippe" uniqKey="Picaut P" first="Philippe" last="Picaut">Philippe Picaut</name><affiliation><nlm:affiliation>Research Institute of Traumatology and Orthopaedics, Nizhnyi Novgorod, Russia.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Approved botulinum toxin A products require reconstitution. AbobotulinumtoxinA solution for injection is a ready-to-use liquid formulation of abobotulinumtoxinA.</div></front></TEI><pubmed><MedlineCitation Status="In-Data-Review" Owner="NLM"><PMID Version="1">27653448</PMID><DateCreated><Year>2016</Year><Month>09</Month><Day>22</Day></DateCreated><DateRevised><Year>2016</Year><Month>11</Month><Day>18</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>31</Volume><Issue>11</Issue><PubDate><Year>2016</Year><Month>Nov</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial.</ArticleTitle><Pagination><MedlinePgn>1649-1657</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.26760</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Approved botulinum toxin A products require reconstitution. AbobotulinumtoxinA solution for injection is a ready-to-use liquid formulation of abobotulinumtoxinA.</AbstractText><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">The objective of this study was to demonstrate the superior efficacy of abobotulinumtoxinA solution for injection to placebo and to test the noninferior efficacy of abobotulinumtoxinA solution for injection versus abobotulinumtoxinA (dry formulation) in cervical dystonia.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This was a phase-3, multicenter, prospective, double-blind, randomized, active, and placebo-controlled study (N = 369). Patients with cervical dystonia were randomized (3:3:1) to abobotulinumtoxinA solution for injection 500 U, abobotulinumtoxinA 500 U, or placebo. Following the double-blind phase, patients received abobotulinumtoxinA solution for injection, open-label, for up to 4 cycles. The primary outcome was change from baseline at week 4 of the Toronto Western Spasmodic Torticollis Rating Scale total score. Secondary measures included change from baseline or cycle baseline in Toronto Western Spasmodic Torticollis Rating Scale scores.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">At week 4, both products were superior to placebo (Toronto Western Spasmodic Torticollis Rating Scale total score least square mean decrease from baseline, abobotulinumtoxinA solution for injection 500 U -12.5, abobotulinumtoxinA 500 U -14.0, placebo -3.9; P < .0001 vs placebo). The noninferiority limit of 3 points in the Toronto Western Spasmodic Torticollis Rating Scale total score at week 4 was not met for abobotulinumtoxinA solution for injection versus abobotulinumtoxinA. Toronto Western Spasmodic Torticollis Rating Scale total score reductions were maintained for up to 4 cycles of abobotulinumtoxinA solution for injection open-label follow-up treatment. Safety profiles of abobotulinumtoxinA solution for injection and abobotulinumtoxinA were similar, with dysphagia and injection-site pain the most frequent drug-related adverse events.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Although the predefined noninferiority criterion was not met, abobotulinumtoxinA solution for injection was similarly effective to freeze-dried abobotulinumtoxinA in reducing Toronto Western Spasmodic Torticollis Rating Scale total scores with a similar safety profile. AbobotulinumtoxinA solution for injection efficacy was maintained with chronic open-label treatment, and this novel formulation may add convenience as well as dosing accuracy to treatment with abobotulinumtoxinA. © 2016 International Parkinson and Movement Disorder Society.</AbstractText><CopyrightInformation>© 2016 International Parkinson and Movement Disorder Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Poewe</LastName><ForeName>Werner</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Department of Neurology, Innsbruck Medical University/University Hospital, Innsbruck, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Burbaud</LastName><ForeName>Pierre</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Clinical Neurophysiology, CHU de Bordeaux, Bordeaux, France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Institut des Maladies Neurodégénératives, Université de Bordeaux, Bordeaux, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Castelnovo</LastName><ForeName>Giovanni</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of Neurology, University Hospital Caremeau, Nimes, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jost</LastName><ForeName>Wolfgang H</ForeName><Initials>WH</Initials><AffiliationInfo><Affiliation>Department of Neurology, University of Freiburg, Freiburg, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ceballos-Baumann</LastName><ForeName>Andres O</ForeName><Initials>AO</Initials><AffiliationInfo><Affiliation>Schön Klinik München Schwabing, Department of Neurology, Technische Universität München, München, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Banach</LastName><ForeName>Marta</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Neurology, Jagiellonian University Medical College, Kraków, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Potulska-Chromik</LastName><ForeName>Anna</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Neurology, Medical University of Warsaw, Warsaw, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ferreira</LastName><ForeName>Joaquim J</ForeName><Initials>JJ</Initials><AffiliationInfo><Affiliation>Clinical Pharmacology Unit, Instituto de Medicina Molecular, Faculty of Medicine, University of Lisbon, Lisbon, Portugal.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bihari</LastName><ForeName>Katalin</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>National Institute of Clinical Neurosciences, Budapest, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ehler</LastName><ForeName>Edvard</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Neurology, County Hospital Pardubice, Pardubice, Czech Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bares</LastName><ForeName>Martin</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>1st Department of Neurology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>St Anne's University Hospital, Brno, Czech Republic.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Neurology, Medical School, University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dzyak</LastName><ForeName>Lyudmyla A</ForeName><Initials>LA</Initials><AffiliationInfo><Affiliation>Dnipropetrovsk State Medical Academy, Dnipropetrovsk Regional Clinical Hospital Mechnykov, Mechnykov, Ukraine.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Neurology, Zhovtneva, Ploshcha, Ukraine.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Belova</LastName><ForeName>Anna N</ForeName><Initials>AN</Initials><AffiliationInfo><Affiliation>Research Institute of Traumatology and Orthopaedics, Nizhnyi Novgorod, Russia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pham</LastName><ForeName>Emmanuel</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Ipsen Innovation, Les Ulis, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Liu</LastName><ForeName>Wenzhong Jerry</ForeName><Initials>WJ</Initials><AffiliationInfo><Affiliation>Ipsen Biopharmaceuticals Inc, Basking Ridge, New Jersey, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Picaut</LastName><ForeName>Philippe</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Research Institute of Traumatology and Orthopaedics, Nizhnyi Novgorod, Russia.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>09</Month><Day>21</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Toronto Western Spasmodic Torticollis Rating Scale</Keyword><Keyword MajorTopicYN="N">abobotulinumtoxinA solution for injection</Keyword><Keyword MajorTopicYN="N">cervical dystonia</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>04</Month><Day>20</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>07</Month><Day>13</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>07</Month><Day>24</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>9</Month><Day>23</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>9</Month><Day>23</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>9</Month><Day>23</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27653448</ArticleId><ArticleId IdType="doi">10.1002/mds.26760</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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