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Patients with prior myocardial infarction, stroke, or symptomatic peripheral arterial disease in the CHARISMA trial

Identifieur interne : 009419 ( Main/Exploration ); précédent : 009418; suivant : 009420

Patients with prior myocardial infarction, stroke, or symptomatic peripheral arterial disease in the CHARISMA trial

Auteurs : Deepak L. Bhatt [États-Unis] ; Marcus D. Flather [Royaume-Uni] ; Werner Hacke [Allemagne] ; Peter B. Berger [États-Unis] ; Henry R. Black [États-Unis] ; William E. Boden [États-Unis] ; Patrice Cacoub [France] ; Eric A. Cohen [Canada] ; Mark A. Creager [États-Unis] ; J. Donald Easton [États-Unis] ; Christian W. Hamm [Allemagne] ; Graeme J. Hankey [Australie] ; S. Claiborne Johnston [États-Unis] ; Koon-Hou Mak [Singapour] ; Jean-Louis Mas [France] ; Gilles Montalescot ; Thomas A. Pearson ; P. Gabriel Steg ; Steven R. Steinhubl ; Michael A. Weber ; Liz Fabry-Ribaudo [États-Unis] ; TINGFEI HU [États-Unis] ; Eric J. Topol ; Keith A. A. Fox

Source :

RBID : Pascal:07-0270186

Descripteurs français

English descriptors

Abstract

Objectives The purpose of this study was to determine the possible benefit of dual antiplatelet therapy in patients with prior myocardial infarction (Ml), ischemic stroke, or symptomatic peripheral arterial disease (PAD). Background Dual antiplatelet therapy with clopidogrel plus aspirin has been validated in the settings of acute coronary syndromes and coronary stenting. The value of this combination was recently evaluated in the CHARISMA (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance) trial, where no statistically significant benefit was found in the overall broad population of stable patients studied. Methods We identified the subgroup in the CHARISMA trial who were enrolled with documented prior Ml, ischemic stroke, or symptomatic PAD. Results A total of 9,478 patients met the inclusion criteria for this analysis. The median duration of follow-up was 27.6 months. The rate of cardiovascular death, Ml, or stroke was significantly lower in the clopidogrel plus aspirin arm than in the placebo plus aspirin arm: 7.3% versus 8.8% (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.72 to 0.96, p = 0.01). Additionally, hospitalizations for ischemia were significantly decreased, 11.4% versus 13.2% (HR 0.86, 95% Cl 0.76 to 0.96, p = 0.008). There was no significant difference in the rate of severe bleeding: 1.7% versus 1.5% (HR 1.12, 95% Cl 0.81 to 1.53, p = 0.50); moderate bleeding was significantly increased: 2.0% versus 1.3% (HR 1.60, 95% Cl 1.16 to 2.20, p = 0.004). Conclusions In this analysis of the CHARISMA trial, the large number of patients with documented prior Ml, ischemic stroke, or symptomatic PAD appeared to derive significant benefit from dual antiplatelet therapy with clopidogrel plus aspirin. Such patients may benefit from intensification of antithrombotic therapy beyond aspirin alone, a concept that future trials will need to validate.


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Le document en format XML

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<name sortKey="Berger, Peter B" sort="Berger, Peter B" uniqKey="Berger P" first="Peter B." last="Berger">Peter B. Berger</name>
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<name sortKey="Cohen, Eric A" sort="Cohen, Eric A" uniqKey="Cohen E" first="Eric A." last="Cohen">Eric A. Cohen</name>
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<name sortKey="Mak, Koon Hou" sort="Mak, Koon Hou" uniqKey="Mak K" first="Koon-Hou" last="Mak">Koon-Hou Mak</name>
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<s1>Gleneagles Medical Centre</s1>
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<name sortKey="Mas, Jean Louis" sort="Mas, Jean Louis" uniqKey="Mas J" first="Jean-Louis" last="Mas">Jean-Louis Mas</name>
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<s1>Department of Neurology and Stroke Unit, Sainte-Anne Hospital</s1>
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<region type="region">Île-de-France</region>
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<name sortKey="Montalescot, Gilles" sort="Montalescot, Gilles" uniqKey="Montalescot G" first="Gilles" last="Montalescot">Gilles Montalescot</name>
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<name sortKey="Pearson, Thomas A" sort="Pearson, Thomas A" uniqKey="Pearson T" first="Thomas A." last="Pearson">Thomas A. Pearson</name>
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<name sortKey="Gabriel Steg, P" sort="Gabriel Steg, P" uniqKey="Gabriel Steg P" first="P." last="Gabriel Steg">P. Gabriel Steg</name>
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<name sortKey="Steinhubl, Steven R" sort="Steinhubl, Steven R" uniqKey="Steinhubl S" first="Steven R." last="Steinhubl">Steven R. Steinhubl</name>
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<name sortKey="Weber, Michael A" sort="Weber, Michael A" uniqKey="Weber M" first="Michael A." last="Weber">Michael A. Weber</name>
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<name sortKey="Fabry Ribaudo, Liz" sort="Fabry Ribaudo, Liz" uniqKey="Fabry Ribaudo L" first="Liz" last="Fabry-Ribaudo">Liz Fabry-Ribaudo</name>
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<s1>Department of Cardiovascular Medicine, Cleveland Clinic</s1>
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<name sortKey="Tingfei Hu" sort="Tingfei Hu" uniqKey="Tingfei Hu" last="Tingfei Hu">TINGFEI HU</name>
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<s1>Department of Cardiovascular Medicine, Cleveland Clinic</s1>
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<name sortKey="Topol, Eric J" sort="Topol, Eric J" uniqKey="Topol E" first="Eric J." last="Topol">Eric J. Topol</name>
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<name sortKey="Fox, Keith A A" sort="Fox, Keith A A" uniqKey="Fox K" first="Keith A. A." last="Fox">Keith A. A. Fox</name>
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<title xml:lang="en" level="a">Patients with prior myocardial infarction, stroke, or symptomatic peripheral arterial disease in the CHARISMA trial</title>
<author>
<name sortKey="Bhatt, Deepak L" sort="Bhatt, Deepak L" uniqKey="Bhatt D" first="Deepak L." last="Bhatt">Deepak L. Bhatt</name>
<affiliation wicri:level="2">
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<s1>Department of Cardiovascular Medicine, Cleveland Clinic</s1>
<s2>Cleveland, Ohio</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">Ohio</region>
</placeName>
</affiliation>
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<name sortKey="Flather, Marcus D" sort="Flather, Marcus D" uniqKey="Flather M" first="Marcus D." last="Flather">Marcus D. Flather</name>
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<inist:fA14 i1="02">
<s1>Clinical Trials and Evaluation Unit, Royal Brompton Hospital</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<placeName>
<settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
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<name sortKey="Hacke, Werner" sort="Hacke, Werner" uniqKey="Hacke W" first="Werner" last="Hacke">Werner Hacke</name>
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<name sortKey="Berger, Peter B" sort="Berger, Peter B" uniqKey="Berger P" first="Peter B." last="Berger">Peter B. Berger</name>
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<name sortKey="Black, Henry R" sort="Black, Henry R" uniqKey="Black H" first="Henry R." last="Black">Henry R. Black</name>
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</placeName>
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<name sortKey="Boden, William E" sort="Boden, William E" uniqKey="Boden W" first="William E." last="Boden">William E. Boden</name>
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<s1>Division of Cardiology, Kaleida Healthcare</s1>
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<region type="state">État de New York</region>
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<name sortKey="Cacoub, Patrice" sort="Cacoub, Patrice" uniqKey="Cacoub P" first="Patrice" last="Cacoub">Patrice Cacoub</name>
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<s1>Department of Internal Medicine, Hopital Pitie-Salpetriere</s1>
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<name sortKey="Cohen, Eric A" sort="Cohen, Eric A" uniqKey="Cohen E" first="Eric A." last="Cohen">Eric A. Cohen</name>
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<s1>Division of Cardiology, Sunnybrook and Women's College Health Science Centre</s1>
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<name sortKey="Creager, Mark A" sort="Creager, Mark A" uniqKey="Creager M" first="Mark A." last="Creager">Mark A. Creager</name>
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<s1>Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School</s1>
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<region type="state">Massachusetts</region>
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<name sortKey="Easton, J Donald" sort="Easton, J Donald" uniqKey="Easton J" first="J. Donald" last="Easton">J. Donald Easton</name>
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<s1>Department of Neurology, Rhode Island Hospital and Brown University</s1>
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<region type="state">Rhode Island</region>
</placeName>
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<name sortKey="Hamm, Christian W" sort="Hamm, Christian W" uniqKey="Hamm C" first="Christian W." last="Hamm">Christian W. Hamm</name>
<affiliation wicri:level="1">
<inist:fA14 i1="11">
<s1>Department of Cardiology, Kerckhoff-Klinik Center</s1>
<s2>Bad Nauheim</s2>
<s3>DEU</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<wicri:noRegion>Bad Nauheim</wicri:noRegion>
<wicri:noRegion>Kerckhoff-Klinik Center</wicri:noRegion>
<wicri:noRegion>Bad Nauheim</wicri:noRegion>
</affiliation>
</author>
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<name sortKey="Hankey, Graeme J" sort="Hankey, Graeme J" uniqKey="Hankey G" first="Graeme J." last="Hankey">Graeme J. Hankey</name>
<affiliation wicri:level="1">
<inist:fA14 i1="12">
<s1>Department of Neurology, Royal Perth Hospital and School of Medicine and Pharmacology, The University of Western Australia</s1>
<s2>Perth</s2>
<s3>AUS</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Perth</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Claiborne Johnston, S" sort="Claiborne Johnston, S" uniqKey="Claiborne Johnston S" first="S." last="Claiborne Johnston">S. Claiborne Johnston</name>
<affiliation wicri:level="2">
<inist:fA14 i1="13">
<s1>Department of Neurology, University of California San Francisco</s1>
<s2>San Francisco, California</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Mak, Koon Hou" sort="Mak, Koon Hou" uniqKey="Mak K" first="Koon-Hou" last="Mak">Koon-Hou Mak</name>
<affiliation wicri:level="1">
<inist:fA14 i1="14">
<s1>Gleneagles Medical Centre</s1>
<s3>SGP</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Singapour</country>
<wicri:noRegion>Gleneagles Medical Centre</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Mas, Jean Louis" sort="Mas, Jean Louis" uniqKey="Mas J" first="Jean-Louis" last="Mas">Jean-Louis Mas</name>
<affiliation wicri:level="3">
<inist:fA14 i1="15">
<s1>Department of Neurology and Stroke Unit, Sainte-Anne Hospital</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName>
<region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Montalescot, Gilles" sort="Montalescot, Gilles" uniqKey="Montalescot G" first="Gilles" last="Montalescot">Gilles Montalescot</name>
</author>
<author>
<name sortKey="Pearson, Thomas A" sort="Pearson, Thomas A" uniqKey="Pearson T" first="Thomas A." last="Pearson">Thomas A. Pearson</name>
</author>
<author>
<name sortKey="Gabriel Steg, P" sort="Gabriel Steg, P" uniqKey="Gabriel Steg P" first="P." last="Gabriel Steg">P. Gabriel Steg</name>
</author>
<author>
<name sortKey="Steinhubl, Steven R" sort="Steinhubl, Steven R" uniqKey="Steinhubl S" first="Steven R." last="Steinhubl">Steven R. Steinhubl</name>
</author>
<author>
<name sortKey="Weber, Michael A" sort="Weber, Michael A" uniqKey="Weber M" first="Michael A." last="Weber">Michael A. Weber</name>
</author>
<author>
<name sortKey="Fabry Ribaudo, Liz" sort="Fabry Ribaudo, Liz" uniqKey="Fabry Ribaudo L" first="Liz" last="Fabry-Ribaudo">Liz Fabry-Ribaudo</name>
<affiliation wicri:level="2">
<inist:fA14 i1="01">
<s1>Department of Cardiovascular Medicine, Cleveland Clinic</s1>
<s2>Cleveland, Ohio</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">Ohio</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Tingfei Hu" sort="Tingfei Hu" uniqKey="Tingfei Hu" last="Tingfei Hu">TINGFEI HU</name>
<affiliation wicri:level="2">
<inist:fA14 i1="01">
<s1>Department of Cardiovascular Medicine, Cleveland Clinic</s1>
<s2>Cleveland, Ohio</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">Ohio</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Topol, Eric J" sort="Topol, Eric J" uniqKey="Topol E" first="Eric J." last="Topol">Eric J. Topol</name>
</author>
<author>
<name sortKey="Fox, Keith A A" sort="Fox, Keith A A" uniqKey="Fox K" first="Keith A. A." last="Fox">Keith A. A. Fox</name>
</author>
</analytic>
<series>
<title level="j" type="main">Journal of the American College of Cardiology</title>
<title level="j" type="abbreviated">J. Am. Coll. Cardiol.</title>
<idno type="ISSN">0735-1097</idno>
<imprint>
<date when="2007">2007</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">Journal of the American College of Cardiology</title>
<title level="j" type="abbreviated">J. Am. Coll. Cardiol.</title>
<idno type="ISSN">0735-1097</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Cardiology</term>
<term>Circulatory system</term>
<term>Clinical trial</term>
<term>Human</term>
<term>Lower limb</term>
<term>Myocardial infarction</term>
<term>Occlusive arterial disease</term>
<term>Patient</term>
<term>Phlebology</term>
<term>Stroke</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Infarctus myocarde</term>
<term>Accident cérébrovasculaire</term>
<term>Artériopathie oblitérante</term>
<term>Homme</term>
<term>Malade</term>
<term>Membre inférieur</term>
<term>Essai clinique</term>
<term>Appareil circulatoire</term>
<term>Cardiologie</term>
<term>Phlébologie</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Objectives The purpose of this study was to determine the possible benefit of dual antiplatelet therapy in patients with prior myocardial infarction (Ml), ischemic stroke, or symptomatic peripheral arterial disease (PAD). Background Dual antiplatelet therapy with clopidogrel plus aspirin has been validated in the settings of acute coronary syndromes and coronary stenting. The value of this combination was recently evaluated in the CHARISMA (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance) trial, where no statistically significant benefit was found in the overall broad population of stable patients studied. Methods We identified the subgroup in the CHARISMA trial who were enrolled with documented prior Ml, ischemic stroke, or symptomatic PAD. Results A total of 9,478 patients met the inclusion criteria for this analysis. The median duration of follow-up was 27.6 months. The rate of cardiovascular death, Ml, or stroke was significantly lower in the clopidogrel plus aspirin arm than in the placebo plus aspirin arm: 7.3% versus 8.8% (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.72 to 0.96, p = 0.01). Additionally, hospitalizations for ischemia were significantly decreased, 11.4% versus 13.2% (HR 0.86, 95% Cl 0.76 to 0.96, p = 0.008). There was no significant difference in the rate of severe bleeding: 1.7% versus 1.5% (HR 1.12, 95% Cl 0.81 to 1.53, p = 0.50); moderate bleeding was significantly increased: 2.0% versus 1.3% (HR 1.60, 95% Cl 1.16 to 2.20, p = 0.004). Conclusions In this analysis of the CHARISMA trial, the large number of patients with documented prior Ml, ischemic stroke, or symptomatic PAD appeared to derive significant benefit from dual antiplatelet therapy with clopidogrel plus aspirin. Such patients may benefit from intensification of antithrombotic therapy beyond aspirin alone, a concept that future trials will need to validate.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>Royaume-Uni</li>
<li>Singapour</li>
<li>États-Unis</li>
</country>
<region>
<li>Angleterre</li>
<li>Bade-Wurtemberg</li>
<li>Californie</li>
<li>District de Karlsruhe</li>
<li>Grand Londres</li>
<li>Massachusetts</li>
<li>Ohio</li>
<li>Pennsylvanie</li>
<li>Rhode Island</li>
<li>État de New York</li>
<li>Île-de-France</li>
</region>
<settlement>
<li>Heidelberg</li>
<li>Londres</li>
<li>Paris</li>
</settlement>
</list>
<tree>
<noCountry>
<name sortKey="Fox, Keith A A" sort="Fox, Keith A A" uniqKey="Fox K" first="Keith A. A." last="Fox">Keith A. A. Fox</name>
<name sortKey="Gabriel Steg, P" sort="Gabriel Steg, P" uniqKey="Gabriel Steg P" first="P." last="Gabriel Steg">P. Gabriel Steg</name>
<name sortKey="Montalescot, Gilles" sort="Montalescot, Gilles" uniqKey="Montalescot G" first="Gilles" last="Montalescot">Gilles Montalescot</name>
<name sortKey="Pearson, Thomas A" sort="Pearson, Thomas A" uniqKey="Pearson T" first="Thomas A." last="Pearson">Thomas A. Pearson</name>
<name sortKey="Steinhubl, Steven R" sort="Steinhubl, Steven R" uniqKey="Steinhubl S" first="Steven R." last="Steinhubl">Steven R. Steinhubl</name>
<name sortKey="Topol, Eric J" sort="Topol, Eric J" uniqKey="Topol E" first="Eric J." last="Topol">Eric J. Topol</name>
<name sortKey="Weber, Michael A" sort="Weber, Michael A" uniqKey="Weber M" first="Michael A." last="Weber">Michael A. Weber</name>
</noCountry>
<country name="États-Unis">
<region name="Ohio">
<name sortKey="Bhatt, Deepak L" sort="Bhatt, Deepak L" uniqKey="Bhatt D" first="Deepak L." last="Bhatt">Deepak L. Bhatt</name>
</region>
<name sortKey="Berger, Peter B" sort="Berger, Peter B" uniqKey="Berger P" first="Peter B." last="Berger">Peter B. Berger</name>
<name sortKey="Black, Henry R" sort="Black, Henry R" uniqKey="Black H" first="Henry R." last="Black">Henry R. Black</name>
<name sortKey="Boden, William E" sort="Boden, William E" uniqKey="Boden W" first="William E." last="Boden">William E. Boden</name>
<name sortKey="Claiborne Johnston, S" sort="Claiborne Johnston, S" uniqKey="Claiborne Johnston S" first="S." last="Claiborne Johnston">S. Claiborne Johnston</name>
<name sortKey="Creager, Mark A" sort="Creager, Mark A" uniqKey="Creager M" first="Mark A." last="Creager">Mark A. Creager</name>
<name sortKey="Easton, J Donald" sort="Easton, J Donald" uniqKey="Easton J" first="J. Donald" last="Easton">J. Donald Easton</name>
<name sortKey="Fabry Ribaudo, Liz" sort="Fabry Ribaudo, Liz" uniqKey="Fabry Ribaudo L" first="Liz" last="Fabry-Ribaudo">Liz Fabry-Ribaudo</name>
<name sortKey="Tingfei Hu" sort="Tingfei Hu" uniqKey="Tingfei Hu" last="Tingfei Hu">TINGFEI HU</name>
</country>
<country name="Royaume-Uni">
<region name="Angleterre">
<name sortKey="Flather, Marcus D" sort="Flather, Marcus D" uniqKey="Flather M" first="Marcus D." last="Flather">Marcus D. Flather</name>
</region>
</country>
<country name="Allemagne">
<region name="Bade-Wurtemberg">
<name sortKey="Hacke, Werner" sort="Hacke, Werner" uniqKey="Hacke W" first="Werner" last="Hacke">Werner Hacke</name>
</region>
<name sortKey="Hamm, Christian W" sort="Hamm, Christian W" uniqKey="Hamm C" first="Christian W." last="Hamm">Christian W. Hamm</name>
</country>
<country name="France">
<region name="Île-de-France">
<name sortKey="Cacoub, Patrice" sort="Cacoub, Patrice" uniqKey="Cacoub P" first="Patrice" last="Cacoub">Patrice Cacoub</name>
</region>
<name sortKey="Mas, Jean Louis" sort="Mas, Jean Louis" uniqKey="Mas J" first="Jean-Louis" last="Mas">Jean-Louis Mas</name>
</country>
<country name="Canada">
<noRegion>
<name sortKey="Cohen, Eric A" sort="Cohen, Eric A" uniqKey="Cohen E" first="Eric A." last="Cohen">Eric A. Cohen</name>
</noRegion>
</country>
<country name="Australie">
<noRegion>
<name sortKey="Hankey, Graeme J" sort="Hankey, Graeme J" uniqKey="Hankey G" first="Graeme J." last="Hankey">Graeme J. Hankey</name>
</noRegion>
</country>
<country name="Singapour">
<noRegion>
<name sortKey="Mak, Koon Hou" sort="Mak, Koon Hou" uniqKey="Mak K" first="Koon-Hou" last="Mak">Koon-Hou Mak</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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