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Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study.

Identifieur interne : 002D48 ( PubMed/Checkpoint ); précédent : 002D47; suivant : 002D49

Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study.

Auteurs : Christophe Hézode [France] ; Gideon M. Hirschfield [Royaume-Uni] ; Wayne Ghesquiere [Canada] ; William Sievert [Australie] ; Maribel Rodriguez-Torres [Porto Rico] ; Stephen D. Shafran [Canada] ; Paul J. Thuluvath [États-Unis] ; Harvey A. Tatum [États-Unis] ; Imam Waked [Égypte] ; Gamal Esmat [Égypte] ; Eric J. Lawitz [États-Unis] ; Vinod K. Rustgi [États-Unis] ; Stanislas Pol [France] ; Nina Weis [Danemark] ; Paul J. Pockros [États-Unis] ; Marc Bourlière [France] ; Lawrence Serfaty [France] ; John M. Vierling [États-Unis] ; Michael W. Fried [États-Unis] ; Ola Weiland [Suède] ; Maurizia R. Brunetto [Italie] ; Gregory T. Everson [États-Unis] ; Stefan Zeuzem [Allemagne] ; Paul Y. Kwo [États-Unis] ; Mark Sulkowski [États-Unis] ; Norbert Br U [États-Unis] ; Dennis Hernandez [États-Unis] ; Fiona Mcphee [États-Unis] ; Megan Wind-Rotolo [États-Unis] ; Zhaohui Liu [États-Unis] ; Stephanie Noviello [États-Unis] ; Eric A. Hughes [États-Unis] ; Philip D. Yin [États-Unis] ; Steven Schnittman [États-Unis]

Source :

RBID : pubmed:25080450

Descripteurs français

English descriptors

Abstract

To evaluate the safety and efficacy of daclatasvir, an HCV NS5A inhibitor with pangenotypic activity, administered with peginterferon-alfa-2a/ribavirin.

DOI: 10.1136/gutjnl-2014-307498
PubMed: 25080450


Affiliations:


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pubmed:25080450

Le document en format XML

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<nlm:affiliation>Indiana University, Indianapolis, Indiana, USA.</nlm:affiliation>
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<name sortKey="Wind Rotolo, Megan" sort="Wind Rotolo, Megan" uniqKey="Wind Rotolo M" first="Megan" last="Wind-Rotolo">Megan Wind-Rotolo</name>
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<name sortKey="Liu, Zhaohui" sort="Liu, Zhaohui" uniqKey="Liu Z" first="Zhaohui" last="Liu">Zhaohui Liu</name>
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<name sortKey="Noviello, Stephanie" sort="Noviello, Stephanie" uniqKey="Noviello S" first="Stephanie" last="Noviello">Stephanie Noviello</name>
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<name sortKey="Yin, Philip D" sort="Yin, Philip D" uniqKey="Yin P" first="Philip D" last="Yin">Philip D. Yin</name>
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<title xml:lang="en">Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study.</title>
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<name sortKey="Thuluvath, Paul J" sort="Thuluvath, Paul J" uniqKey="Thuluvath P" first="Paul J" last="Thuluvath">Paul J. Thuluvath</name>
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<region type="state">Maryland</region>
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<author>
<name sortKey="Tatum, Harvey A" sort="Tatum, Harvey A" uniqKey="Tatum H" first="Harvey A" last="Tatum">Harvey A. Tatum</name>
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<region type="state">Oklahoma</region>
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<author>
<name sortKey="Waked, Imam" sort="Waked, Imam" uniqKey="Waked I" first="Imam" last="Waked">Imam Waked</name>
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<name sortKey="Esmat, Gamal" sort="Esmat, Gamal" uniqKey="Esmat G" first="Gamal" last="Esmat">Gamal Esmat</name>
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<name sortKey="Rustgi, Vinod K" sort="Rustgi, Vinod K" uniqKey="Rustgi V" first="Vinod K" last="Rustgi">Vinod K. Rustgi</name>
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<name sortKey="Weis, Nina" sort="Weis, Nina" uniqKey="Weis N" first="Nina" last="Weis">Nina Weis</name>
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<name sortKey="Serfaty, Lawrence" sort="Serfaty, Lawrence" uniqKey="Serfaty L" first="Lawrence" last="Serfaty">Lawrence Serfaty</name>
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<nlm:affiliation>Hôpital Saint-Antoine, Paris, France.</nlm:affiliation>
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<name sortKey="Fried, Michael W" sort="Fried, Michael W" uniqKey="Fried M" first="Michael W" last="Fried">Michael W. Fried</name>
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<region type="state">Caroline du Nord</region>
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<name sortKey="Weiland, Ola" sort="Weiland, Ola" uniqKey="Weiland O" first="Ola" last="Weiland">Ola Weiland</name>
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<country xml:lang="fr">Suède</country>
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<name sortKey="Brunetto, Maurizia R" sort="Brunetto, Maurizia R" uniqKey="Brunetto M" first="Maurizia R" last="Brunetto">Maurizia R. Brunetto</name>
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<nlm:affiliation>Hepatology Unit, University Hospital of Pisa, Pisa, Italy.</nlm:affiliation>
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<settlement type="city">Pise</settlement>
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<nlm:affiliation>University of Colorado Denver, Aurora, Colorado, USA.</nlm:affiliation>
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<wicri:regionArea>University of Colorado Denver, Aurora, Colorado</wicri:regionArea>
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<region type="state">Colorado</region>
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<name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name>
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<region type="land" nuts="1">Hesse (Land)</region>
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<nlm:affiliation>Indiana University, Indianapolis, Indiana, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Indiana University, Indianapolis, Indiana</wicri:regionArea>
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<region type="state">Indiana</region>
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<name sortKey="Sulkowski, Mark" sort="Sulkowski, Mark" uniqKey="Sulkowski M" first="Mark" last="Sulkowski">Mark Sulkowski</name>
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<nlm:affiliation>Johns Hopkins University, Baltimore, Maryland, USA.</nlm:affiliation>
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<wicri:regionArea>Johns Hopkins University, Baltimore, Maryland</wicri:regionArea>
<placeName>
<region type="state">Maryland</region>
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<name sortKey="Br U, Norbert" sort="Br U, Norbert" uniqKey="Br U N" first="Norbert" last="Br U">Norbert Br U</name>
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<nlm:affiliation>James J. Peters VA Medical Center, Bronx, New York, USA.</nlm:affiliation>
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<wicri:regionArea>James J. Peters VA Medical Center, Bronx, New York</wicri:regionArea>
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<region type="state">État de New York</region>
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<name sortKey="Hernandez, Dennis" sort="Hernandez, Dennis" uniqKey="Hernandez D" first="Dennis" last="Hernandez">Dennis Hernandez</name>
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<nlm:affiliation>Bristol-Myers Squibb, Clinical Research and Development, Wallingford, Connecticut, USA.</nlm:affiliation>
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<region type="state">Connecticut</region>
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<name sortKey="Mcphee, Fiona" sort="Mcphee, Fiona" uniqKey="Mcphee F" first="Fiona" last="Mcphee">Fiona Mcphee</name>
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<nlm:affiliation>Bristol-Myers Squibb, Clinical Research and Development, Wallingford, Connecticut, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Bristol-Myers Squibb, Clinical Research and Development, Wallingford, Connecticut</wicri:regionArea>
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<region type="state">Connecticut</region>
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<name sortKey="Wind Rotolo, Megan" sort="Wind Rotolo, Megan" uniqKey="Wind Rotolo M" first="Megan" last="Wind-Rotolo">Megan Wind-Rotolo</name>
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<nlm:affiliation>Bristol-Myers Squibb, Research and Development, Princeton, New Jersey, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
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<region type="state">New Jersey</region>
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<author>
<name sortKey="Liu, Zhaohui" sort="Liu, Zhaohui" uniqKey="Liu Z" first="Zhaohui" last="Liu">Zhaohui Liu</name>
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<nlm:affiliation>Bristol-Myers Squibb Research and Development, Hopewell, New Jersey, USA.</nlm:affiliation>
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<region type="state">New Jersey</region>
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<name sortKey="Noviello, Stephanie" sort="Noviello, Stephanie" uniqKey="Noviello S" first="Stephanie" last="Noviello">Stephanie Noviello</name>
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<name sortKey="Yin, Philip D" sort="Yin, Philip D" uniqKey="Yin P" first="Philip D" last="Yin">Philip D. Yin</name>
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<region type="state">Connecticut</region>
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<name sortKey="Schnittman, Steven" sort="Schnittman, Steven" uniqKey="Schnittman S" first="Steven" last="Schnittman">Steven Schnittman</name>
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<div type="abstract" xml:lang="en">To evaluate the safety and efficacy of daclatasvir, an HCV NS5A inhibitor with pangenotypic activity, administered with peginterferon-alfa-2a/ribavirin.</div>
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<ArticleTitle>Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study.</ArticleTitle>
<Pagination>
<MedlinePgn>948-56</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1136/gutjnl-2014-307498</ELocationID>
<Abstract>
<AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To evaluate the safety and efficacy of daclatasvir, an HCV NS5A inhibitor with pangenotypic activity, administered with peginterferon-alfa-2a/ribavirin.</AbstractText>
<AbstractText Label="DESIGN" NlmCategory="METHODS">In this Phase 2b double-blind, placebo-controlled study, treatment-naive adults with HCV genotype 1 (N=365) or 4 (N=30) infection were randomly assigned (2:2:1) to daclatasvir 20 mg or 60 mg, or placebo once daily plus weekly peginterferon-alfa-2a and twice-daily ribavirin. Daclatasvir recipients achieving protocol-defined response (PDR; HCV-RNA</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Overall, eRVR was achieved by 54.4% (80/147) of genotype 1-infected patients receiving daclatasvir 20 mg, 54.1% (79/146) receiving 60 mg versus 13.9% (10/72) receiving placebo. SVR24 was achieved among 87 (59.2%), 87 (59.6%), and 27 (37.5%) patients in these groups, respectively. Higher proportions of genotype 4-infected patients receiving daclatasvir 20 mg (66.7%; 8/12) or 60 mg (100.0%; 12/12) achieved SVR24 versus placebo (50.0%; 3/6). A majority of daclatasvir-treated patients achieved PDR and experienced less virologic failure and higher SVR24 rates with a shortened 24-week treatment duration. Adverse events occurred with similar frequency across all treatment groups.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The combination of daclatasvir/peginterferon-alfa/ribavirin was generally well tolerated and achieved higher SVR24 rates compared with placebo/peginterferon-alfa/ribavirin among patients infected with HCV genotype 1 or 4.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION NUMBER" NlmCategory="BACKGROUND">NCT01125189.</AbstractText>
<CopyrightInformation>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.</CopyrightInformation>
</Abstract>
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<LastName>Hézode</LastName>
<ForeName>Christophe</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>Hôpital Henri Mondor, AP-HP, Université Paris-Est, Inserm U955, Créteil, France.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Hirschfield</LastName>
<ForeName>Gideon M</ForeName>
<Initials>GM</Initials>
<AffiliationInfo>
<Affiliation>Centre for Liver Research and NIHR Biomedical Research Unit, University of Birmingham, Birmingham, UK.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Ghesquiere</LastName>
<ForeName>Wayne</ForeName>
<Initials>W</Initials>
<AffiliationInfo>
<Affiliation>Vancouver Island Health Authority & University of British Columbia, Victoria, British Columbia, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Sievert</LastName>
<ForeName>William</ForeName>
<Initials>W</Initials>
<AffiliationInfo>
<Affiliation>Monash University and Monash Health, Melbourne, Australia.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Rodriguez-Torres</LastName>
<ForeName>Maribel</ForeName>
<Initials>M</Initials>
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<Affiliation>Fundacion De Investigacion, San Juan Bautista School of Medicine, San Juan, Puerto Rico.</Affiliation>
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<LastName>Shafran</LastName>
<ForeName>Stephen D</ForeName>
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<Affiliation>University of Alberta Hospital, Edmonton, Canada.</Affiliation>
</AffiliationInfo>
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<LastName>Thuluvath</LastName>
<ForeName>Paul J</ForeName>
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<Affiliation>Mercy Medical Center, Baltimore, Maryland, USA.</Affiliation>
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<Affiliation>Options Health Research, LLC, Tulsa, Oklahoma, USA.</Affiliation>
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<ForeName>Imam</ForeName>
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<Affiliation>National Liver Institute, Shebin Elkom, Egypt.</Affiliation>
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<Affiliation>Endemic Medicine and Hepatogastroenterology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.</Affiliation>
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<Affiliation>Texas Liver Institute, University of Texas Health Science Center, San Antonio, Texas, USA.</Affiliation>
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<ForeName>Stanislas</ForeName>
<Initials>S</Initials>
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<Affiliation>Inserm U1016 and Liver Unit, Université Paris Descartes, Hôpital Cochin, Paris, France.</Affiliation>
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<Affiliation>Copenhagen University Hospital, Hvidovre, Denmark.</Affiliation>
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<Affiliation>Scripps Clinic, La Jolla, California, USA.</Affiliation>
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<ForeName>Marc</ForeName>
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<Affiliation>Hôpital Saint Joseph, Marseille, France.</Affiliation>
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<ForeName>Michael W</ForeName>
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<Affiliation>University of North Carolina, Chapel Hill, North Carolina, USA.</Affiliation>
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<Affiliation>Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden.</Affiliation>
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<LastName>Brunetto</LastName>
<ForeName>Maurizia R</ForeName>
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<Affiliation>Hepatology Unit, University Hospital of Pisa, Pisa, Italy.</Affiliation>
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<ForeName>Gregory T</ForeName>
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<Affiliation>University of Colorado Denver, Aurora, Colorado, USA.</Affiliation>
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<Affiliation>Goethe University, Frankfurt, Germany.</Affiliation>
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<Affiliation>Indiana University, Indianapolis, Indiana, USA.</Affiliation>
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<ForeName>Mark</ForeName>
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<Affiliation>Johns Hopkins University, Baltimore, Maryland, USA.</Affiliation>
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<ForeName>Norbert</ForeName>
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<Affiliation>James J. Peters VA Medical Center, Bronx, New York, USA.</Affiliation>
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<LastName>Hernandez</LastName>
<ForeName>Dennis</ForeName>
<Initials>D</Initials>
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<Affiliation>Bristol-Myers Squibb, Clinical Research and Development, Wallingford, Connecticut, USA.</Affiliation>
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<LastName>McPhee</LastName>
<ForeName>Fiona</ForeName>
<Initials>F</Initials>
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<Affiliation>Bristol-Myers Squibb, Clinical Research and Development, Wallingford, Connecticut, USA.</Affiliation>
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<LastName>Wind-Rotolo</LastName>
<ForeName>Megan</ForeName>
<Initials>M</Initials>
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<Affiliation>Bristol-Myers Squibb, Research and Development, Princeton, New Jersey, USA.</Affiliation>
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<LastName>Liu</LastName>
<ForeName>Zhaohui</ForeName>
<Initials>Z</Initials>
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<Affiliation>Bristol-Myers Squibb Research and Development, Hopewell, New Jersey, USA.</Affiliation>
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<Affiliation>Bristol-Myers Squibb, Research and Development, Princeton, New Jersey, USA.</Affiliation>
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<ForeName>Eric A</ForeName>
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<ForeName>Philip D</ForeName>
<Initials>PD</Initials>
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<Affiliation>Bristol-Myers Squibb, Clinical Research and Development, Wallingford, Connecticut, USA.</Affiliation>
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<LastName>Schnittman</LastName>
<ForeName>Steven</ForeName>
<Initials>S</Initials>
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<Affiliation>Bristol-Myers Squibb, Clinical Research and Development, Wallingford, Connecticut, USA.</Affiliation>
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<Language>eng</Language>
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<DataBankName>ClinicalTrials.gov</DataBankName>
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<Year>2014</Year>
<Month>07</Month>
<Day>30</Day>
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<ISSNLinking>0017-5749</ISSNLinking>
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<DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
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<name sortKey="Esmat, Gamal" sort="Esmat, Gamal" uniqKey="Esmat G" first="Gamal" last="Esmat">Gamal Esmat</name>
</country>
<country name="Danemark">
<noRegion>
<name sortKey="Weis, Nina" sort="Weis, Nina" uniqKey="Weis N" first="Nina" last="Weis">Nina Weis</name>
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<country name="Suède">
<region name="Svealand">
<name sortKey="Weiland, Ola" sort="Weiland, Ola" uniqKey="Weiland O" first="Ola" last="Weiland">Ola Weiland</name>
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<country name="Italie">
<region name="Toscane">
<name sortKey="Brunetto, Maurizia R" sort="Brunetto, Maurizia R" uniqKey="Brunetto M" first="Maurizia R" last="Brunetto">Maurizia R. Brunetto</name>
</region>
</country>
<country name="Allemagne">
<region name="Hesse (Land)">
<name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name>
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