Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial.
Identifieur interne : 000744 ( PubMed/Checkpoint ); précédent : 000743; suivant : 000745Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial.
Auteurs : Miguel Martin [Espagne] ; Frankie A. Holmes [États-Unis] ; Bent Ejlertsen [Danemark] ; Suzette Delaloge [France] ; Beverly Moy [États-Unis] ; Hiroji Iwata [Japon] ; Gunter Von Minckwitz [Allemagne] ; Stephen K L. Chia [Canada] ; Janine Mansi [Royaume-Uni] ; Carlos H. Barrios [Brésil] ; Michael Gnant [Autriche] ; Zorica Tomaševi [Serbie] ; Neelima Denduluri [États-Unis] ; Robert Šeparovi [Croatie] ; Erhan Gokmen [Turquie] ; Anna Bashford [Nouvelle-Zélande] ; Manuel Ruiz Borrego [Espagne] ; Sung-Bae Kim [Corée du Sud] ; Erik Hugger Jakobsen [Danemark] ; Audrone Ciceniene [Lituanie] ; Kenichi Inoue [Japon] ; Friedrich Overkamp [Allemagne] ; Joan B. Heijns [Pays-Bas] ; Anne C. Armstrong [Royaume-Uni] ; John S. Link [États-Unis] ; Anil Abraham Joy [Canada] ; Richard Bryce [États-Unis] ; Alvin Wong [États-Unis] ; Susan Moran [États-Unis] ; Bin Yao [États-Unis] ; Feng Xu [États-Unis] ; Alan Auerbach [États-Unis] ; Marc Buyse [Belgique] ; Arlene Chan [Australie]Source :
- The Lancet. Oncology [ 1474-5488 ] ; 2017.
Abstract
ExteNET showed that 1 year of neratinib, an irreversible pan-HER tyrosine kinase inhibitor, significantly improves 2-year invasive disease-free survival after trastuzumab-based adjuvant therapy in women with HER2-positive breast cancer. We report updated efficacy outcomes from a protocol-defined 5-year follow-up sensitivity analysis and long-term toxicity findings.
DOI: 10.1016/S1470-2045(17)30717-9
PubMed: 29146401
Affiliations:
- Allemagne, Australie, Autriche, Belgique, Brésil, Canada, Corée du Sud, Croatie, Danemark, Espagne, France, Japon, Lituanie, Nouvelle-Zélande, Pays-Bas, Royaume-Uni, Serbie, Turquie, États-Unis
- Angleterre, Californie, Communauté de Madrid, District de Münster, Grand Londres, Grand Manchester, Hovedstaden, Massachusetts, Rhénanie-du-Nord-Westphalie, Rio Grande do Sul, Région capitale de Séoul, Texas, Vienne (Autriche), Virginie
- Copenhague, Londres, Madrid, Manchester, Porto Alegre, Recklinghausen (Ruhr), Séoul, Vienne (Autriche)
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pubmed:29146401Le document en format XML
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<author><name sortKey="Iwata, Hiroji" sort="Iwata, Hiroji" uniqKey="Iwata H" first="Hiroji" last="Iwata">Hiroji Iwata</name>
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<author><name sortKey="Bashford, Anna" sort="Bashford, Anna" uniqKey="Bashford A" first="Anna" last="Bashford">Anna Bashford</name>
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<author><name sortKey="Ruiz Borrego, Manuel" sort="Ruiz Borrego, Manuel" uniqKey="Ruiz Borrego M" first="Manuel" last="Ruiz Borrego">Manuel Ruiz Borrego</name>
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<author><name sortKey="Inoue, Kenichi" sort="Inoue, Kenichi" uniqKey="Inoue K" first="Kenichi" last="Inoue">Kenichi Inoue</name>
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<author><name sortKey="Armstrong, Anne C" sort="Armstrong, Anne C" uniqKey="Armstrong A" first="Anne C" last="Armstrong">Anne C. Armstrong</name>
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<author><name sortKey="Link, John S" sort="Link, John S" uniqKey="Link J" first="John S" last="Link">John S. Link</name>
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<author><name sortKey="Joy, Anil Abraham" sort="Joy, Anil Abraham" uniqKey="Joy A" first="Anil Abraham" last="Joy">Anil Abraham Joy</name>
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<author><name sortKey="Bryce, Richard" sort="Bryce, Richard" uniqKey="Bryce R" first="Richard" last="Bryce">Richard Bryce</name>
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<author><name sortKey="Wong, Alvin" sort="Wong, Alvin" uniqKey="Wong A" first="Alvin" last="Wong">Alvin Wong</name>
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<author><name sortKey="Moran, Susan" sort="Moran, Susan" uniqKey="Moran S" first="Susan" last="Moran">Susan Moran</name>
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<author><name sortKey="Yao, Bin" sort="Yao, Bin" uniqKey="Yao B" first="Bin" last="Yao">Bin Yao</name>
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<author><name sortKey="Xu, Feng" sort="Xu, Feng" uniqKey="Xu F" first="Feng" last="Xu">Feng Xu</name>
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<author><name sortKey="Auerbach, Alan" sort="Auerbach, Alan" uniqKey="Auerbach A" first="Alan" last="Auerbach">Alan Auerbach</name>
<affiliation wicri:level="2"><nlm:affiliation>Puma Biotechnology Inc, Los Angeles, CA, USA.</nlm:affiliation>
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<placeName><region type="state">Californie</region>
</placeName>
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<author><name sortKey="Buyse, Marc" sort="Buyse, Marc" uniqKey="Buyse M" first="Marc" last="Buyse">Marc Buyse</name>
<affiliation wicri:level="1"><nlm:affiliation>International Drug Development Institute, Louvain-la-Neuve, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>International Drug Development Institute, Louvain-la-Neuve</wicri:regionArea>
<wicri:noRegion>Louvain-la-Neuve</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Chan, Arlene" sort="Chan, Arlene" uniqKey="Chan A" first="Arlene" last="Chan">Arlene Chan</name>
<affiliation wicri:level="1"><nlm:affiliation>Breast Cancer Research Centre-Western Australia, Perth, WA, Australia; Curtin University, Perth, WA, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Breast Cancer Research Centre-Western Australia, Perth, WA, Australia; Curtin University, Perth, WA</wicri:regionArea>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial.</title>
<author><name sortKey="Martin, Miguel" sort="Martin, Miguel" uniqKey="Martin M" first="Miguel" last="Martin">Miguel Martin</name>
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<author><name sortKey="Holmes, Frankie A" sort="Holmes, Frankie A" uniqKey="Holmes F" first="Frankie A" last="Holmes">Frankie A. Holmes</name>
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<author><name sortKey="Delaloge, Suzette" sort="Delaloge, Suzette" uniqKey="Delaloge S" first="Suzette" last="Delaloge">Suzette Delaloge</name>
<affiliation wicri:level="1"><nlm:affiliation>Institut Gustave Roussy, Villejuif, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Institut Gustave Roussy, Villejuif</wicri:regionArea>
<wicri:noRegion>Villejuif</wicri:noRegion>
<wicri:noRegion>Villejuif</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Moy, Beverly" sort="Moy, Beverly" uniqKey="Moy B" first="Beverly" last="Moy">Beverly Moy</name>
<affiliation wicri:level="2"><nlm:affiliation>Massachusetts General Hospital Cancer Center, Boston, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Massachusetts General Hospital Cancer Center, Boston, MA</wicri:regionArea>
<placeName><region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Iwata, Hiroji" sort="Iwata, Hiroji" uniqKey="Iwata H" first="Hiroji" last="Iwata">Hiroji Iwata</name>
<affiliation wicri:level="1"><nlm:affiliation>Aichi Cancer Center, Chikusa-ku, Nagoya, Japan.</nlm:affiliation>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Aichi Cancer Center, Chikusa-ku, Nagoya</wicri:regionArea>
<wicri:noRegion>Nagoya</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Von Minckwitz, Gunter" sort="Von Minckwitz, Gunter" uniqKey="Von Minckwitz G" first="Gunter" last="Von Minckwitz">Gunter Von Minckwitz</name>
<affiliation wicri:level="1"><nlm:affiliation>Luisenkrankenhaus, German Breast Group Forschungs GmbH, Düsseldorf, Neulsenburg, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Luisenkrankenhaus, German Breast Group Forschungs GmbH, Düsseldorf, Neulsenburg</wicri:regionArea>
<wicri:noRegion>Neulsenburg</wicri:noRegion>
<wicri:noRegion>Neulsenburg</wicri:noRegion>
<wicri:noRegion>Neulsenburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Chia, Stephen K L" sort="Chia, Stephen K L" uniqKey="Chia S" first="Stephen K L" last="Chia">Stephen K L. Chia</name>
<affiliation wicri:level="1"><nlm:affiliation>BC Cancer Agency, Vancouver, BC, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>BC Cancer Agency, Vancouver, BC</wicri:regionArea>
<wicri:noRegion>BC</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mansi, Janine" sort="Mansi, Janine" uniqKey="Mansi J" first="Janine" last="Mansi">Janine Mansi</name>
<affiliation wicri:level="3"><nlm:affiliation>Guy's and St Thomas' Hospital National Health Service Foundation Trust and Biomedical Research Centre, King's College, London, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Guy's and St Thomas' Hospital National Health Service Foundation Trust and Biomedical Research Centre, King's College, London</wicri:regionArea>
<placeName><settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Barrios, Carlos H" sort="Barrios, Carlos H" uniqKey="Barrios C" first="Carlos H" last="Barrios">Carlos H. Barrios</name>
<affiliation wicri:level="3"><nlm:affiliation>Pontifical Catholic University of Rio Grande do Sul School of Medicine, Porto Alegre, Brazil.</nlm:affiliation>
<country xml:lang="fr">Brésil</country>
<wicri:regionArea>Pontifical Catholic University of Rio Grande do Sul School of Medicine, Porto Alegre</wicri:regionArea>
<placeName><settlement type="city">Porto Alegre</settlement>
<region type="state">Rio Grande do Sul</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Gnant, Michael" sort="Gnant, Michael" uniqKey="Gnant M" first="Michael" last="Gnant">Michael Gnant</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Surgery and Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria.</nlm:affiliation>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Department of Surgery and Comprehensive Cancer Centre, Medical University of Vienna, Vienna</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Tomasevi, Zorica" sort="Tomasevi, Zorica" uniqKey="Tomasevi Z" first="Zorica" last="Tomaševi">Zorica Tomaševi</name>
<affiliation wicri:level="1"><nlm:affiliation>Daily Chemotherapy Hospital, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.</nlm:affiliation>
<country xml:lang="fr">Serbie</country>
<wicri:regionArea>Daily Chemotherapy Hospital, Institute for Oncology and Radiology of Serbia, Belgrade</wicri:regionArea>
<wicri:noRegion>Belgrade</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Denduluri, Neelima" sort="Denduluri, Neelima" uniqKey="Denduluri N" first="Neelima" last="Denduluri">Neelima Denduluri</name>
<affiliation wicri:level="2"><nlm:affiliation>Virginia Cancer Specialists, Arlington, VA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Virginia Cancer Specialists, Arlington, VA</wicri:regionArea>
<placeName><region type="state">Virginie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Separovi, Robert" sort="Separovi, Robert" uniqKey="Separovi R" first="Robert" last="Šeparovi">Robert Šeparovi</name>
<affiliation wicri:level="1"><nlm:affiliation>University Hospital for Tumors, University Hospital Center "Sestre milosrdnice", Zagreb, Croatia.</nlm:affiliation>
<country xml:lang="fr">Croatie</country>
<wicri:regionArea>University Hospital for Tumors, University Hospital Center "Sestre milosrdnice", Zagreb</wicri:regionArea>
<wicri:noRegion>Zagreb</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gokmen, Erhan" sort="Gokmen, Erhan" uniqKey="Gokmen E" first="Erhan" last="Gokmen">Erhan Gokmen</name>
<affiliation wicri:level="1"><nlm:affiliation>Ege University Faculty of Medicine, Izmir, Turkey.</nlm:affiliation>
<country xml:lang="fr">Turquie</country>
<wicri:regionArea>Ege University Faculty of Medicine, Izmir</wicri:regionArea>
<wicri:noRegion>Izmir</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bashford, Anna" sort="Bashford, Anna" uniqKey="Bashford A" first="Anna" last="Bashford">Anna Bashford</name>
<affiliation wicri:level="1"><nlm:affiliation>Auckland Hospital, Auckland, New Zealand.</nlm:affiliation>
<country xml:lang="fr">Nouvelle-Zélande</country>
<wicri:regionArea>Auckland Hospital, Auckland</wicri:regionArea>
<wicri:noRegion>Auckland</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ruiz Borrego, Manuel" sort="Ruiz Borrego, Manuel" uniqKey="Ruiz Borrego M" first="Manuel" last="Ruiz Borrego">Manuel Ruiz Borrego</name>
<affiliation wicri:level="1"><nlm:affiliation>Oncology Department, Hospital Universitario Virgen del Rocio, Seville, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Oncology Department, Hospital Universitario Virgen del Rocio, Seville</wicri:regionArea>
<wicri:noRegion>Seville</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kim, Sung Bae" sort="Kim, Sung Bae" uniqKey="Kim S" first="Sung-Bae" last="Kim">Sung-Bae Kim</name>
<affiliation wicri:level="3"><nlm:affiliation>Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.</nlm:affiliation>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>Asan Medical Center, University of Ulsan College of Medicine, Seoul</wicri:regionArea>
<placeName><settlement type="city">Séoul</settlement>
<region type="capital">Région capitale de Séoul</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jakobsen, Erik Hugger" sort="Jakobsen, Erik Hugger" uniqKey="Jakobsen E" first="Erik Hugger" last="Jakobsen">Erik Hugger Jakobsen</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Oncology, Lillebaelt Hospital, Vejle, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Oncology, Lillebaelt Hospital, Vejle</wicri:regionArea>
<wicri:noRegion>Vejle</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ciceniene, Audrone" sort="Ciceniene, Audrone" uniqKey="Ciceniene A" first="Audrone" last="Ciceniene">Audrone Ciceniene</name>
<affiliation wicri:level="1"><nlm:affiliation>Oncology Institute of Vilnius University, Vilnius, Lithuania.</nlm:affiliation>
<country xml:lang="fr">Lituanie</country>
<wicri:regionArea>Oncology Institute of Vilnius University, Vilnius</wicri:regionArea>
<wicri:noRegion>Vilnius</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Inoue, Kenichi" sort="Inoue, Kenichi" uniqKey="Inoue K" first="Kenichi" last="Inoue">Kenichi Inoue</name>
<affiliation wicri:level="1"><nlm:affiliation>Breast Oncology, Saitama Cancer Center, Kita-Adachi, Japan.</nlm:affiliation>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Breast Oncology, Saitama Cancer Center, Kita-Adachi</wicri:regionArea>
<wicri:noRegion>Kita-Adachi</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Overkamp, Friedrich" sort="Overkamp, Friedrich" uniqKey="Overkamp F" first="Friedrich" last="Overkamp">Friedrich Overkamp</name>
<affiliation wicri:level="3"><nlm:affiliation>Oncologianova GmbH, Recklinghausen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Oncologianova GmbH, Recklinghausen</wicri:regionArea>
<placeName><region type="land" nuts="1">Rhénanie-du-Nord-Westphalie</region>
<region type="district" nuts="2">District de Münster</region>
<settlement type="city">Recklinghausen (Ruhr)</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Heijns, Joan B" sort="Heijns, Joan B" uniqKey="Heijns J" first="Joan B" last="Heijns">Joan B. Heijns</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Medical Oncology, Amphia Hospital, Breda, Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Medical Oncology, Amphia Hospital, Breda</wicri:regionArea>
<wicri:noRegion>Breda</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Armstrong, Anne C" sort="Armstrong, Anne C" uniqKey="Armstrong A" first="Anne C" last="Armstrong">Anne C. Armstrong</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Oncology, Christie Hospital Manchester, Manchester, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Oncology, Christie Hospital Manchester, Manchester</wicri:regionArea>
<placeName><settlement type="city">Manchester</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Manchester</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Link, John S" sort="Link, John S" uniqKey="Link J" first="John S" last="Link">John S. Link</name>
<affiliation wicri:level="2"><nlm:affiliation>Breastlink Medical Group Inc, Santa Ana, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Breastlink Medical Group Inc, Santa Ana, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Joy, Anil Abraham" sort="Joy, Anil Abraham" uniqKey="Joy A" first="Anil Abraham" last="Joy">Anil Abraham Joy</name>
<affiliation wicri:level="1"><nlm:affiliation>University of Alberta, Department of Oncology, Cross Cancer Institute, Edmonton, AB, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>University of Alberta, Department of Oncology, Cross Cancer Institute, Edmonton, AB</wicri:regionArea>
<wicri:noRegion>AB</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bryce, Richard" sort="Bryce, Richard" uniqKey="Bryce R" first="Richard" last="Bryce">Richard Bryce</name>
<affiliation wicri:level="2"><nlm:affiliation>Puma Biotechnology Inc, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Puma Biotechnology Inc, Los Angeles, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Wong, Alvin" sort="Wong, Alvin" uniqKey="Wong A" first="Alvin" last="Wong">Alvin Wong</name>
<affiliation wicri:level="2"><nlm:affiliation>Puma Biotechnology Inc, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Puma Biotechnology Inc, Los Angeles, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Moran, Susan" sort="Moran, Susan" uniqKey="Moran S" first="Susan" last="Moran">Susan Moran</name>
<affiliation wicri:level="2"><nlm:affiliation>Puma Biotechnology Inc, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Puma Biotechnology Inc, Los Angeles, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Yao, Bin" sort="Yao, Bin" uniqKey="Yao B" first="Bin" last="Yao">Bin Yao</name>
<affiliation wicri:level="2"><nlm:affiliation>Puma Biotechnology Inc, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Puma Biotechnology Inc, Los Angeles, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Xu, Feng" sort="Xu, Feng" uniqKey="Xu F" first="Feng" last="Xu">Feng Xu</name>
<affiliation wicri:level="2"><nlm:affiliation>Puma Biotechnology Inc, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Puma Biotechnology Inc, Los Angeles, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Auerbach, Alan" sort="Auerbach, Alan" uniqKey="Auerbach A" first="Alan" last="Auerbach">Alan Auerbach</name>
<affiliation wicri:level="2"><nlm:affiliation>Puma Biotechnology Inc, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Puma Biotechnology Inc, Los Angeles, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Buyse, Marc" sort="Buyse, Marc" uniqKey="Buyse M" first="Marc" last="Buyse">Marc Buyse</name>
<affiliation wicri:level="1"><nlm:affiliation>International Drug Development Institute, Louvain-la-Neuve, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>International Drug Development Institute, Louvain-la-Neuve</wicri:regionArea>
<wicri:noRegion>Louvain-la-Neuve</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Chan, Arlene" sort="Chan, Arlene" uniqKey="Chan A" first="Arlene" last="Chan">Arlene Chan</name>
<affiliation wicri:level="1"><nlm:affiliation>Breast Cancer Research Centre-Western Australia, Perth, WA, Australia; Curtin University, Perth, WA, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Breast Cancer Research Centre-Western Australia, Perth, WA, Australia; Curtin University, Perth, WA</wicri:regionArea>
<wicri:noRegion>WA</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j">The Lancet. Oncology</title>
<idno type="eISSN">1474-5488</idno>
<imprint><date when="2017" type="published">2017</date>
</imprint>
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<front><div type="abstract" xml:lang="en">ExteNET showed that 1 year of neratinib, an irreversible pan-HER tyrosine kinase inhibitor, significantly improves 2-year invasive disease-free survival after trastuzumab-based adjuvant therapy in women with HER2-positive breast cancer. We report updated efficacy outcomes from a protocol-defined 5-year follow-up sensitivity analysis and long-term toxicity findings.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">29146401</PMID>
<DateCreated><Year>2017</Year>
<Month>11</Month>
<Day>17</Day>
</DateCreated>
<DateRevised><Year>2017</Year>
<Month>11</Month>
<Day>17</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-5488</ISSN>
<JournalIssue CitedMedium="Internet"><PubDate><Year>2017</Year>
<Month>Nov</Month>
<Day>13</Day>
</PubDate>
</JournalIssue>
<Title>The Lancet. Oncology</Title>
<ISOAbbreviation>Lancet Oncol.</ISOAbbreviation>
</Journal>
<ArticleTitle>Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial.</ArticleTitle>
<ELocationID EIdType="pii" ValidYN="Y">S1470-2045(17)30717-9</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(17)30717-9</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">ExteNET showed that 1 year of neratinib, an irreversible pan-HER tyrosine kinase inhibitor, significantly improves 2-year invasive disease-free survival after trastuzumab-based adjuvant therapy in women with HER2-positive breast cancer. We report updated efficacy outcomes from a protocol-defined 5-year follow-up sensitivity analysis and long-term toxicity findings.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">In this ongoing randomised, double-blind, placebo-controlled, phase 3 trial, eligible women aged 18 years or older (≥20 years in Japan) with stage 1-3c (modified to stage 2-3c in February, 2010) operable breast cancer, who had completed neoadjuvant and adjuvant chemotherapy plus trastuzumab with no evidence of disease recurrence or metastatic disease at study entry. Patients who were eligible patients were randomly assigned (1:1) via permuted blocks stratified according to hormone receptor status (hormone receptor-positive vs hormone receptor-negative), nodal status (0 vs 1-3 vs or ≥4 positive nodes), and trastuzumab adjuvant regimen (given sequentially vs concurrently with chemotherapy), then implemented centrally via an interactive voice and web-response system, to receive 1 year of oral neratinib 240 mg/day or matching placebo. Treatment was given continuously for 1 year, unless disease recurrence or new breast cancer, intolerable adverse events, or consent withdrawal occurred. Patients, investigators, and trial funder were masked to treatment allocation. The predefined endpoint of the 5-year analysis was invasive disease-free survival, analysed by intention to treat. ExteNET is registered with ClinicalTrials.gov, number NCT00878709, and is closed to new participants.</AbstractText>
<AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between July 9, 2009, and Oct 24, 2011, 2840 eligible women with early HER2-positive breast cancer were recruited from community-based and academic institutions in 40 countries and randomly assigned to receive neratinib (n=1420) or placebo (n=1420). After a median follow-up of 5·2 years (IQR 2·1-5·3), patients in the neratinib group had significantly fewer invasive disease-free survival events than those in the placebo group (116 vs 163 events; stratified hazard ratio 0·73, 95% CI 0·57-0·92, p=0·0083). The 5-year invasive disease-free survival was 90·2% (95% CI 88·3-91·8) in the neratinib group and 87·7% (85·7-89·4) in the placebo group. Without diarrhoea prophylaxis, the most common grade 3-4 adverse events in the neratinib group, compared with the placebo group, were diarrhoea (561 [40%] grade 3 and one [<1%] grade 4 with neratinib vs 23 [2%] grade 3 with placebo), vomiting (grade 3: 47 [3%] vs five [<1%]), and nausea (grade 3: 26 [2%] vs two [<1%]). Treatment-emergent serious adverse events occurred in 103 (7%) women in the neratinib group and 85 (6%) women in the placebo group. No evidence of increased risk of long-term toxicity or long-term adverse consequences of neratinib-associated diarrhoea were identified with neratinib compared with placebo.</AbstractText>
<AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">At the 5-year follow-up, 1 year of extended adjuvant therapy with neratinib, administered after chemotherapy and trastuzumab, significantly reduced the proportion of clinically relevant breast cancer relapses-ie, those that might lead to death, such as distant and locoregional relapses outside the preserved breast-without increasing the risk of long-term toxicity. An analysis of overall survival is planned after 248 events.</AbstractText>
<AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Wyeth, Pfizer, and Puma Biotechnology.</AbstractText>
<CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Martin</LastName>
<ForeName>Miguel</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Instituto de Investigación Sanitaria Gregorio Marañón, Grupo Español de Investigación en Cáncer de Mama (GEICAM), Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Universidad Complutense, Madrid, Spain. Electronic address: mmartin@geicam.org.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Holmes</LastName>
<ForeName>Frankie A</ForeName>
<Initials>FA</Initials>
<AffiliationInfo><Affiliation>Texas Oncology, Houston, TX, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ejlertsen</LastName>
<ForeName>Bent</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Rigshospitalet, Copenhagen, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Delaloge</LastName>
<ForeName>Suzette</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Institut Gustave Roussy, Villejuif, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Moy</LastName>
<ForeName>Beverly</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Massachusetts General Hospital Cancer Center, Boston, MA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Iwata</LastName>
<ForeName>Hiroji</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Aichi Cancer Center, Chikusa-ku, Nagoya, Japan.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>von Minckwitz</LastName>
<ForeName>Gunter</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Luisenkrankenhaus, German Breast Group Forschungs GmbH, Düsseldorf, Neulsenburg, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Chia</LastName>
<ForeName>Stephen K L</ForeName>
<Initials>SKL</Initials>
<AffiliationInfo><Affiliation>BC Cancer Agency, Vancouver, BC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mansi</LastName>
<ForeName>Janine</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Guy's and St Thomas' Hospital National Health Service Foundation Trust and Biomedical Research Centre, King's College, London, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Barrios</LastName>
<ForeName>Carlos H</ForeName>
<Initials>CH</Initials>
<AffiliationInfo><Affiliation>Pontifical Catholic University of Rio Grande do Sul School of Medicine, Porto Alegre, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gnant</LastName>
<ForeName>Michael</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Surgery and Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Tomašević</LastName>
<ForeName>Zorica</ForeName>
<Initials>Z</Initials>
<AffiliationInfo><Affiliation>Daily Chemotherapy Hospital, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Denduluri</LastName>
<ForeName>Neelima</ForeName>
<Initials>N</Initials>
<AffiliationInfo><Affiliation>Virginia Cancer Specialists, Arlington, VA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Šeparović</LastName>
<ForeName>Robert</ForeName>
<Initials>R</Initials>
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<Author ValidYN="Y"><LastName>Link</LastName>
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<Author ValidYN="Y"><LastName>Buyse</LastName>
<ForeName>Marc</ForeName>
<Initials>M</Initials>
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</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Chan</LastName>
<ForeName>Arlene</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Breast Cancer Research Centre-Western Australia, Perth, WA, Australia; Curtin University, Perth, WA, Australia.</Affiliation>
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<Author ValidYN="Y"><CollectiveName>ExteNET Study Group</CollectiveName>
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<Language>eng</Language>
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</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2017</Year>
<Month>11</Month>
<Day>13</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Lancet Oncol</MedlineTA>
<NlmUniqueID>100957246</NlmUniqueID>
<ISSNLinking>1470-2045</ISSNLinking>
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<Investigator ValidYN="Y"><LastName>Rivera</LastName>
<ForeName>Ragene</ForeName>
<Initials>R</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Klein</LastName>
<ForeName>Leonard M</ForeName>
<Initials>LM</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ruxer</LastName>
<ForeName>Robert</ForeName>
<Initials>R</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Wilks</LastName>
<ForeName>Sharon T</ForeName>
<Initials>ST</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kotasek</LastName>
<ForeName>Dusan</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Popov</LastName>
<ForeName>Vasil</ForeName>
<Initials>V</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Taskova</LastName>
<ForeName>Violina</ForeName>
<Initials>V</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Marinova-Venkova</LastName>
<ForeName>Violetka</ForeName>
<Initials>V</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Timcheva</LastName>
<ForeName>Constanta</ForeName>
<Initials>C</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Desbiens</LastName>
<ForeName>Christine</ForeName>
<Initials>C</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ayoub</LastName>
<ForeName>Jean-Pierre</ForeName>
<Initials>JP</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Grenier</LastName>
<ForeName>Debjani</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Marschner</LastName>
<ForeName>Norbert</ForeName>
<Initials>N</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Tesch</LastName>
<ForeName>Hans</ForeName>
<Initials>H</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Lueck</LastName>
<ForeName>Hans-Joachim</ForeName>
<Initials>HJ</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Janssen</LastName>
<ForeName>Jan</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Schwaner</LastName>
<ForeName>Ingo</ForeName>
<Initials>I</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Wahlstrom</LastName>
<ForeName>Stine</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Brix</LastName>
<ForeName>Eva Harder</ForeName>
<Initials>EH</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Vallentin</LastName>
<ForeName>Susanne</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kristensen</LastName>
<ForeName>Dan</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Andreeva</LastName>
<ForeName>Anna</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Glavicic</LastName>
<ForeName>Vesna</ForeName>
<Initials>V</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Calvo Plaza</LastName>
<ForeName>Isabel</ForeName>
<Initials>I</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Anton Torres</LastName>
<ForeName>Antonio</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Veyret</LastName>
<ForeName>Corinne</ForeName>
<Initials>C</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Bergerat</LastName>
<ForeName>Jean-Pierre</ForeName>
<Initials>JP</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Bourbouloux</LastName>
<ForeName>Emmanuelle</ForeName>
<Initials>E</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ella</LastName>
<ForeName>Wendy Ann</ForeName>
<Initials>WA</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Algurafi</LastName>
<ForeName>Hafiz</ForeName>
<Initials>H</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Robinson</LastName>
<ForeName>Anne</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kim</LastName>
<ForeName>Seung Jin</ForeName>
<Initials>SJ</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Taguchi</LastName>
<ForeName>Tetsuya</ForeName>
<Initials>T</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Juozaityte</LastName>
<ForeName>Elona</ForeName>
<Initials>E</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Madretsma</LastName>
<ForeName>Stanley</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Radema</LastName>
<ForeName>Sandra</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Czerniawska-Meier</LastName>
<ForeName>Malgorzata</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Rogowski</LastName>
<ForeName>Wojciech</ForeName>
<Initials>W</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Wagnerova</LastName>
<ForeName>Maria</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Richards</LastName>
<ForeName>Donald A</ForeName>
<Initials>DA</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Tan-Chiu</LastName>
<ForeName>Elizabeth</ForeName>
<Initials>E</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Vasileios</LastName>
<ForeName>Asskikis</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Henderson</LastName>
<ForeName>Charles Arthur</ForeName>
<Initials>CA</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Holden</LastName>
<ForeName>Viran Roger</ForeName>
<Initials>VR</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Wang</LastName>
<ForeName>Xiaojia</ForeName>
<Initials>X</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Tong</LastName>
<ForeName>Zhongsheng</ForeName>
<Initials>Z</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Yang</LastName>
<ForeName>Junlan</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Gonzalez</LastName>
<ForeName>Manuel Enrique</ForeName>
<Initials>ME</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Rezai</LastName>
<ForeName>Mahdi</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Hackmann</LastName>
<ForeName>John</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>de Dueñas</LastName>
<ForeName>Eduardo Martinez</ForeName>
<Initials>EM</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>de Las Heras</LastName>
<ForeName>Begoña Bermejo</ForeName>
<Initials>BB</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Dourthe</LastName>
<ForeName>Louis Marie</ForeName>
<Initials>LM</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Chocteau-Bouju</LastName>
<ForeName>Dorothee</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Bougnoux</LastName>
<ForeName>Philippe</ForeName>
<Initials>P</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kakolyris</LastName>
<ForeName>Stylianos</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kalofonos</LastName>
<ForeName>Haralabos</ForeName>
<Initials>H</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Pectasidis</LastName>
<ForeName>Dimitrios</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ng</LastName>
<ForeName>Ting Ying</ForeName>
<Initials>TY</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Pajkos</LastName>
<ForeName>Gabor</ForeName>
<Initials>G</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Somogyine</LastName>
<ForeName>Eva Ezer</ForeName>
<Initials>EE</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Tonini</LastName>
<ForeName>Giuseppe</ForeName>
<Initials>G</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Giuffrida</LastName>
<ForeName>Dario</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Takao</LastName>
<ForeName>Shintaro</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ishitobi</LastName>
<ForeName>Makoto</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Inaji</LastName>
<ForeName>Hideo</ForeName>
<Initials>H</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Tokuda</LastName>
<ForeName>Yutaka</ForeName>
<Initials>Y</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Wozniak</LastName>
<ForeName>Katarzyna</ForeName>
<Initials>K</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Lungulescu</LastName>
<ForeName>Dan</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Lu</LastName>
<ForeName>Yen-Shen</ForeName>
<Initials>YS</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Chang</LastName>
<ForeName>King-Jen</ForeName>
<Initials>KJ</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Hill</LastName>
<ForeName>Julian</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Croot</LastName>
<ForeName>Christopher Charles</ForeName>
<Initials>CC</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Dekker</LastName>
<ForeName>Albert</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Belman</LastName>
<ForeName>Neil D</ForeName>
<Initials>ND</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Conde</LastName>
<ForeName>Miguel</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Michaelson</LastName>
<ForeName>Richard A</ForeName>
<Initials>RA</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kemmer</LastName>
<ForeName>Kathleen</ForeName>
<Initials>K</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Chui</LastName>
<ForeName>Stephen</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Luoh</LastName>
<ForeName>Shiuh-Wen</ForeName>
<Initials>SW</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Nahum</LastName>
<ForeName>Kenneth</ForeName>
<Initials>K</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Greenspan</LastName>
<ForeName>Andrew R</ForeName>
<Initials>AR</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Nichols</LastName>
<ForeName>Joni C</ForeName>
<Initials>JC</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Encarnacion</LastName>
<ForeName>Carlos A</ForeName>
<Initials>CA</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Niederman</LastName>
<ForeName>Thomas M J</ForeName>
<Initials>TMJ</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Lee</LastName>
<ForeName>Theresa</ForeName>
<Initials>T</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Alexander</LastName>
<ForeName>Roland</ForeName>
<Initials>R</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Gordon</LastName>
<ForeName>Robert</ForeName>
<Initials>R</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Tomova</LastName>
<ForeName>Antoanet</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Rauch</LastName>
<ForeName>Daniel</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Popescu</LastName>
<ForeName>Razvan Andrei</ForeName>
<Initials>RA</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Rojas</LastName>
<ForeName>Gustavo Adolfo</ForeName>
<Initials>GA</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Vanasek</LastName>
<ForeName>Jaroslav</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Neunhoeffer</LastName>
<ForeName>Tanja</ForeName>
<Initials>T</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Barinoff</LastName>
<ForeName>Jana</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Graffunder</LastName>
<ForeName>Gerd</ForeName>
<Initials>G</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Wolfgang</LastName>
<ForeName>Abenhardt</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Bojko</LastName>
<ForeName>Peter</ForeName>
<Initials>P</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Heinrich</LastName>
<ForeName>Bernhard</ForeName>
<Initials>B</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>von der Assen</LastName>
<ForeName>Albert</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Antonovic</LastName>
<ForeName>Bogovic Jurij</ForeName>
<Initials>BJ</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Adrian</LastName>
<ForeName>Lene</ForeName>
<Initials>L</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ramos Vazquez</LastName>
<ForeName>Manuel</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Gonzalez Santiago</LastName>
<ForeName>Santiago</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Dieras</LastName>
<ForeName>Veronique</ForeName>
<Initials>V</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Bishop</LastName>
<ForeName>Jill Mercia</ForeName>
<Initials>JM</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Perren</LastName>
<ForeName>Timothy John</ForeName>
<Initials>TJ</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Varthalitis</LastName>
<ForeName>Ioannis</ForeName>
<Initials>I</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Mavroudis</LastName>
<ForeName>Dimitris</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Georgoulias</LastName>
<ForeName>Vassilis</ForeName>
<Initials>V</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Chow</LastName>
<ForeName>Louis W C</ForeName>
<Initials>LWC</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Yau</LastName>
<ForeName>Chung Cheung Thomas</ForeName>
<Initials>CCT</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Liang</LastName>
<ForeName>Raymond Hin-Suen</ForeName>
<Initials>RH</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Pikó</LastName>
<ForeName>Béla</ForeName>
<Initials>B</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Wéber</LastName>
<ForeName>Agnes</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kaufman</LastName>
<ForeName>Bella</ForeName>
<Initials>B</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Drumea</LastName>
<ForeName>Karen</ForeName>
<Initials>K</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Nuzzo</LastName>
<ForeName>Francesco</ForeName>
<Initials>F</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>De Matteis</LastName>
<ForeName>Andrea</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Nuzzo</LastName>
<ForeName>Francesco</ForeName>
<Initials>F</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Carteni</LastName>
<ForeName>Giacomo</ForeName>
<Initials>G</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Tokunaga</LastName>
<ForeName>Eriko</ForeName>
<Initials>E</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ishida</LastName>
<ForeName>Mayumi</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ohno</LastName>
<ForeName>Shinji</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Sato</LastName>
<ForeName>Nobuaki</ForeName>
<Initials>N</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kuroi</LastName>
<ForeName>Katsumasa</ForeName>
<Initials>K</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Nishimura</LastName>
<ForeName>Reiki</ForeName>
<Initials>R</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Watanabe</LastName>
<ForeName>Junichiro</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Choi</LastName>
<ForeName>Yoon Ji</ForeName>
<Initials>YJ</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Park</LastName>
<ForeName>Kyong Hwa</ForeName>
<Initials>KH</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Wojtukiewicz</LastName>
<ForeName>Marek</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Jassem</LastName>
<ForeName>Jacek</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Loman</LastName>
<ForeName>Niklas</ForeName>
<Initials>N</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Askoy</LastName>
<ForeName>Sercan</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Altundag</LastName>
<ForeName>Mustafa Kadri</ForeName>
<Initials>MK</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Saip</LastName>
<ForeName>Pinar</ForeName>
<Initials>P</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ali</LastName>
<ForeName>Muhammad Amjad</ForeName>
<Initials>MA</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Wade Iii</LastName>
<ForeName>James Lloyd</ForeName>
<Initials>JL</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Chien</LastName>
<ForeName>Amy Jo</ForeName>
<Initials>AJ</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Brandt</LastName>
<ForeName>Debra</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Novik</LastName>
<ForeName>Yelena</ForeName>
<Initials>Y</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Jani</LastName>
<ForeName>Chirag</ForeName>
<Initials>C</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Rice</LastName>
<ForeName>Robert L</ForeName>
<Initials>RL</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Gaffar</LastName>
<ForeName>Yousuf A R</ForeName>
<Initials>YAR</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Keaton</LastName>
<ForeName>Mark R</ForeName>
<Initials>MR</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Bajaj</LastName>
<ForeName>Rajesh</ForeName>
<Initials>R</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kimmick</LastName>
<ForeName>Gretchen</ForeName>
<Initials>G</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Campbell</LastName>
<ForeName>David</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>De Boer</LastName>
<ForeName>Richard Hendry</ForeName>
<Initials>RH</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Turnquest</LastName>
<ForeName>Theodore</ForeName>
<Initials>T</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Lucas</LastName>
<ForeName>Sideras</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Dube</LastName>
<ForeName>Pierre</ForeName>
<Initials>P</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Xu</LastName>
<ForeName>Binghe</ForeName>
<Initials>B</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Schilling</LastName>
<ForeName>Joerg</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Apel</LastName>
<ForeName>Klaus</ForeName>
<Initials>K</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Sorensen</LastName>
<ForeName>Peter Grundtvig</ForeName>
<Initials>PG</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Vestlev</LastName>
<ForeName>Peter Michael</ForeName>
<Initials>PM</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Jensen</LastName>
<ForeName>Brita Bjerregaard</ForeName>
<Initials>BB</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Haahr</LastName>
<ForeName>Vera</ForeName>
<Initials>V</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Lescure</LastName>
<ForeName>Alvaro Rodriguez</ForeName>
<Initials>AR</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Grana Suarez</LastName>
<ForeName>Begona</ForeName>
<Initials>B</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Saura Manich</LastName>
<ForeName>Cristina</ForeName>
<Initials>C</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Jacquin</LastName>
<ForeName>Jean-Philippe</ForeName>
<Initials>JP</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Samreen</LastName>
<ForeName>Ahmed</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Boiangiu</LastName>
<ForeName>Ion</ForeName>
<Initials>I</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Dank</LastName>
<ForeName>Magdolna</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Falci</LastName>
<ForeName>Cristina</ForeName>
<Initials>C</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Jirillo</LastName>
<ForeName>Antonio</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Cinieri</LastName>
<ForeName>Saverio</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ueno</LastName>
<ForeName>Takayuki</ForeName>
<Initials>T</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Sato</LastName>
<ForeName>Fumiaki</ForeName>
<Initials>F</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Yamashiro</LastName>
<ForeName>Hiroyasu</ForeName>
<Initials>H</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Sugie</LastName>
<ForeName>Tomoharu</ForeName>
<Initials>T</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Lee</LastName>
<ForeName>Keun Seok</ForeName>
<Initials>KS</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ro</LastName>
<ForeName>Jung Sil</ForeName>
<Initials>JS</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Park</LastName>
<ForeName>In Hae</ForeName>
<Initials>IH</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Bustam</LastName>
<ForeName>Anita Zarina</ForeName>
<Initials>AZ</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Suszko-Kazarnowicz</LastName>
<ForeName>Malgorzata</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Piktel</LastName>
<ForeName>Artur</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Krzemieniecki</LastName>
<ForeName>Krzysztof</ForeName>
<Initials>K</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Iorga</LastName>
<ForeName>Polizenia Georgeta</ForeName>
<Initials>PG</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Yap</LastName>
<ForeName>Yoon Sim</ForeName>
<Initials>YS</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kakalejcik</LastName>
<ForeName>Marian</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Sevinc</LastName>
<ForeName>Alper</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ozguroglu</LastName>
<ForeName>Mustafa</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Chen</LastName>
<ForeName>Shin-Cheh</ForeName>
<Initials>SC</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Greenberg</LastName>
<ForeName>Richard H</ForeName>
<Initials>RH</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Eisemann</LastName>
<ForeName>Allan Daniel</ForeName>
<Initials>AD</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Droder</LastName>
<ForeName>Robert</ForeName>
<Initials>R</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Abbasi</LastName>
<ForeName>M Rashid</ForeName>
<Initials>MR</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Vaysburd</LastName>
<ForeName>Marina</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Caldera</LastName>
<ForeName>Humberto Jose</ForeName>
<Initials>HJ</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Haley</LastName>
<ForeName>Barbara Bacsik</ForeName>
<Initials>BB</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Robin</LastName>
<ForeName>Erwin</ForeName>
<Initials>E</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Inhorn</LastName>
<ForeName>Roger C</ForeName>
<Initials>RC</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Hufnagel</LastName>
<ForeName>David</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kenyon</LastName>
<ForeName>Peter D</ForeName>
<Initials>PD</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Spremulli</LastName>
<ForeName>Ellen</ForeName>
<Initials>E</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Silverman</LastName>
<ForeName>Paula</ForeName>
<Initials>P</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Jain</LastName>
<ForeName>Sharad</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Weigand</LastName>
<ForeName>Robert</ForeName>
<Initials>R</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Mebis</LastName>
<ForeName>Jeroen</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Koynova</LastName>
<ForeName>Tatyana</ForeName>
<Initials>T</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Lesperance</LastName>
<ForeName>Bernard</ForeName>
<Initials>B</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Prausova</LastName>
<ForeName>Jana</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kohne</LastName>
<ForeName>Claus-Henning</ForeName>
<Initials>CH</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Schneeweiss</LastName>
<ForeName>Andreas</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Jackisch</LastName>
<ForeName>Christian</ForeName>
<Initials>C</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Fuxius</LastName>
<ForeName>Stefan</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Cubedo Cervera</LastName>
<ForeName>Ricardo</ForeName>
<Initials>R</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Urruticoechea Ribate</LastName>
<ForeName>Ander</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Pernas Simon</LastName>
<ForeName>Sonia</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Valero Gallego</LastName>
<ForeName>Jose</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Arcusa Lanza</LastName>
<ForeName>Angels</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Del Pilar Alvarez</LastName>
<ForeName>Maria</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Florian Gerico</LastName>
<ForeName>Jesus</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Cany</LastName>
<ForeName>Laurent</ForeName>
<Initials>L</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Stebbing</LastName>
<ForeName>Justin</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Labudovic</LastName>
<ForeName>Dejan</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Gugic</LastName>
<ForeName>Damir</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Vrbanec</LastName>
<ForeName>Damir</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Roila</LastName>
<ForeName>Fausto</ForeName>
<Initials>F</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Barni</LastName>
<ForeName>Sandro</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Bidoli</LastName>
<ForeName>Paolo</ForeName>
<Initials>P</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Mukai</LastName>
<ForeName>Hirofumi</ForeName>
<Initials>H</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Bermudez</LastName>
<ForeName>Vanessa</ForeName>
<Initials>V</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Eniu</LastName>
<ForeName>Alexandru</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Mirtsching</LastName>
<ForeName>Barry C</ForeName>
<Initials>BC</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ibrahim</LastName>
<ForeName>Emad</ForeName>
<Initials>E</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Trey</LastName>
<ForeName>Joan</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Hergenroeder</LastName>
<ForeName>Paul Francis</ForeName>
<Initials>PF</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Mahmood</LastName>
<ForeName>Aftab</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Gonzalez</LastName>
<ForeName>Anneliese</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kaplan</LastName>
<ForeName>Edward H</ForeName>
<Initials>EH</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ban</LastName>
<ForeName>Stacy</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Patel</LastName>
<ForeName>Dhimant</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Clowney</LastName>
<ForeName>Billy</ForeName>
<Initials>B</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Hoelzer</LastName>
<ForeName>Karen</ForeName>
<Initials>K</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Schwartz</LastName>
<ForeName>Garry H</ForeName>
<Initials>GH</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Salkeni</LastName>
<ForeName>Mohamed</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Abraham</LastName>
<ForeName>Jame</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Narula</LastName>
<ForeName>Sunil</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Jabboury</LastName>
<ForeName>Khaled</ForeName>
<Initials>K</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Mocharnuk</LastName>
<ForeName>Robert Scott</ForeName>
<Initials>RS</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>McDonough</LastName>
<ForeName>Richard H</ForeName>
<Initials>RH</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Sikes</LastName>
<ForeName>David H</ForeName>
<Initials>DH</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kawanchi</LastName>
<ForeName>Ronald H</ForeName>
<Initials>RH</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Schlabach</LastName>
<ForeName>Larry</ForeName>
<Initials>L</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>McCachren</LastName>
<ForeName>Samuel Spence</ForeName>
<Initials>SS</Initials>
<Suffix>Jr</Suffix>
</Investigator>
<Investigator ValidYN="Y"><LastName>Cosgriff</LastName>
<ForeName>Thomas M</ForeName>
<Initials>TM</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Dreisbach</LastName>
<ForeName>Luke</ForeName>
<Initials>L</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>DeMichele</LastName>
<ForeName>Angela</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Pawl</LastName>
<ForeName>Lawrence</ForeName>
<Initials>L</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Lucas</LastName>
<ForeName>Jennifer</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Shinn</LastName>
<ForeName>Lowell C</ForeName>
<Initials>LC</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Alkhouri</LastName>
<ForeName>Nabiel</ForeName>
<Initials>N</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Monga</LastName>
<ForeName>Manish</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Lindquist</LastName>
<ForeName>Deborah L</ForeName>
<Initials>DL</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Anderson</LastName>
<ForeName>Thomas C</ForeName>
<Initials>TC</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Khurshid</LastName>
<ForeName>Humera</ForeName>
<Initials>H</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Witherby</LastName>
<ForeName>Sabrina</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Erickson</LastName>
<ForeName>Nicholette</ForeName>
<Initials>N</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Traynor</LastName>
<ForeName>Ann</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Bose</LastName>
<ForeName>Ron</ForeName>
<Initials>R</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Pluard</LastName>
<ForeName>Timothy J</ForeName>
<Initials>TJ</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Jones</LastName>
<ForeName>Michael C</ForeName>
<Initials>MC</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Prakash</LastName>
<ForeName>Sucharu</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Volterra</LastName>
<ForeName>Fabio</ForeName>
<Initials>F</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Capo</LastName>
<ForeName>Gerardo</ForeName>
<Initials>G</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Flaherty</LastName>
<ForeName>Lawrence E</ForeName>
<Initials>LE</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Gartner</LastName>
<ForeName>Elaina</ForeName>
<Initials>E</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Baidas</LastName>
<ForeName>Said</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Okazaki</LastName>
<ForeName>Ian</ForeName>
<Initials>I</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Nguyen</LastName>
<ForeName>Bichlien</ForeName>
<Initials>B</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Rakowski</LastName>
<ForeName>Thomas</ForeName>
<Initials>T</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Oliff</LastName>
<ForeName>Ira</ForeName>
<Initials>I</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Leach</LastName>
<ForeName>Joseph W</ForeName>
<Initials>JW</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Anderson</LastName>
<ForeName>Daniel</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Kubiak</LastName>
<ForeName>Kendra</ForeName>
<Initials>K</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Tsai</LastName>
<ForeName>Michaela</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Vroman</LastName>
<ForeName>Philippe</ForeName>
<Initials>P</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Deleu</LastName>
<ForeName>Ines</ForeName>
<Initials>I</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Lybaert</LastName>
<ForeName>Willem</ForeName>
<Initials>W</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Borms</LastName>
<ForeName>Marleen</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Couture</LastName>
<ForeName>Felix</ForeName>
<Initials>F</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Wilson</LastName>
<ForeName>Jonathan J</ForeName>
<Initials>JJ</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Hunt</LastName>
<ForeName>Gordon</ForeName>
<Initials>G</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Holland</LastName>
<ForeName>David R</ForeName>
<Initials>DR</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Mingrone</LastName>
<ForeName>Walter</ForeName>
<Initials>W</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Wang</LastName>
<ForeName>Shusen</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Liu</LastName>
<ForeName>Donggeng</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Jiang</LastName>
<ForeName>Zefei</ForeName>
<Initials>Z</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Benesova</LastName>
<ForeName>Vera</ForeName>
<Initials>V</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Smakal</LastName>
<ForeName>Martin</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Garnolova</LastName>
<ForeName>Petra</ForeName>
<Initials>P</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Vesper</LastName>
<ForeName>Anne-Sophie</ForeName>
<Initials>AS</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Neumann</LastName>
<ForeName>Monika</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Janni</LastName>
<ForeName>Wolfgang</ForeName>
<Initials>W</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Liedtke</LastName>
<ForeName>Cornelia</ForeName>
<Initials>C</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Fischer</LastName>
<ForeName>Dorothea</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Grischke</LastName>
<ForeName>Eva-Maria</ForeName>
<Initials>EM</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Seeger</LastName>
<ForeName>Dietmar</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Moebus</LastName>
<ForeName>Volker</ForeName>
<Initials>V</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Prechtl</LastName>
<ForeName>Anita</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Carlos Camara Toral</LastName>
<ForeName>Juan</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Sanchez Munoz</LastName>
<ForeName>Alfonso</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Gonzalez Jimenez</LastName>
<ForeName>Sonia</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Cassinello Espinosa</LastName>
<ForeName>Javier</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Cirauqui</LastName>
<ForeName>Beatriz</ForeName>
<Initials>B</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Margeli Vila</LastName>
<ForeName>Mireia</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Batista Lopez</LastName>
<ForeName>Norberto</ForeName>
<Initials>N</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Chacon Lopez-Muniz</LastName>
<ForeName>Jose Ignacio</ForeName>
<Initials>JI</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>de la Cruz Mora</LastName>
<ForeName>Miguel Angel</ForeName>
<Initials>MA</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Mailliez</LastName>
<ForeName>Audrey</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Vanlemmens</LastName>
<ForeName>Laurence</ForeName>
<Initials>L</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Pouessel</LastName>
<ForeName>Damien</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Espie</LastName>
<ForeName>Marc</ForeName>
<Initials>M</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Conibear</LastName>
<ForeName>John</ForeName>
<Initials>J</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Roylance</LastName>
<ForeName>Rebecca</ForeName>
<Initials>R</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Harnett</LastName>
<ForeName>Adrian</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Geffen</LastName>
<ForeName>David</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Ruggeri</LastName>
<ForeName>Enzo Maria</ForeName>
<Initials>EM</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Gamucci</LastName>
<ForeName>Teresa</ForeName>
<Initials>T</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Van Groeningen</LastName>
<ForeName>Cees J</ForeName>
<Initials>CJ</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Banas</LastName>
<ForeName>Renata</ForeName>
<Initials>R</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Loman</LastName>
<ForeName>Niklas</ForeName>
<Initials>N</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Alkis</LastName>
<ForeName>Necati</ForeName>
<Initials>N</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Hou</LastName>
<ForeName>Ming-Feng</ForeName>
<Initials>MF</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Krie</LastName>
<ForeName>Amy K</ForeName>
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