The Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) study is an adaptive platform trial designed to investigate novel interventions to severe asthma. The study is conducted under a master protocol and utilizes a crossover design with each participant receiving up to five interventions and at least one placebo. Treatment assignments are based on the patients' biomarker profiles and precision health methods are incorporated into the interim and final analyses. We describe key elements of the PrecISE study including the multistage adaptive enrichment strategy, early stopping of an intervention for futility, power calculations, and the primary analysis strategy.
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Univ London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Royal Brompton Hosp, Biomed Res Unit, London SW3 6LY, EnglandUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Chung, Kian Fan
Wenzel, Sally E.
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Univ Pittsburgh, Dept Med, Pittsburgh, PA USAUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Wenzel, Sally E.
Brozek, Jan L.
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McMaster Univ, Dept Clin Epidemiol & Biostat & Med, Hamilton, ON, CanadaUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Brozek, Jan L.
Bush, Andrew
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h-index: 0
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Univ London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Royal Brompton Hosp, Biomed Res Unit, London SW3 6LY, EnglandUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Bush, Andrew
Castro, Mario
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h-index: 0
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Washington Univ, Dept Med, St Louis, MO USAUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Castro, Mario
Sterk, Peter J.
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h-index: 0
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Univ Amsterdam, Acad Med Ctr, Dept Resp Med, NL-1105 AZ Amsterdam, NetherlandsUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Sterk, Peter J.
Adcock, Ian M.
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h-index: 0
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Univ London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, EnglandUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Adcock, Ian M.
Bateman, Eric D.
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h-index: 0
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Univ Cape Town, Lung Inst, ZA-7925 Cape Town, South AfricaUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Bateman, Eric D.
Bel, Elisabeth H.
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h-index: 0
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Univ Amsterdam, Acad Med Ctr, Dept Resp Med, NL-1105 AZ Amsterdam, NetherlandsUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Bel, Elisabeth H.
Bleecker, Eugene R.
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h-index: 0
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Wake Forest Univ, Dept Med, Winston Salem, NC 27109 USAUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Bleecker, Eugene R.
Boulet, Louis-Philippe
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Inst Univ Cardiol & Pneumol Quebec, Ctr Rech, Quebec City, PQ, CanadaUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Boulet, Louis-Philippe
Brightling, Christopher
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Univ Leicester, Inst Lung Hlth, Leicester, Leics, EnglandUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Brightling, Christopher
Chanez, Pascal
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h-index: 0
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Marseille Univ, Dept Malad Resp, Marseille, FranceUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Chanez, Pascal
Dahlen, Sven-Erik
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Karolinska Inst, Inst Environm Med, S-10401 Stockholm, SwedenUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Dahlen, Sven-Erik
Djukanovic, Ratko
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Univ Southampton, Sch Med, Southampton NIHR Resp Biomed Res Unit, Southampton, Hants, England
Southampton Gen Hosp, Southampton SO9 4XY, Hants, EnglandUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Djukanovic, Ratko
Frey, Urs
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h-index: 0
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Univ Basel, Univ Childrens Hosp UKBB, Basel, SwitzerlandUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
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John Hunter Hosp, Hunter Med Res Inst, Newcastle, NSW, AustraliaUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Gibson, Peter
Hamid, Qutayba
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h-index: 0
机构:
McGill Univ, Meakins Christie Labs, Montreal, PQ, CanadaUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Hamid, Qutayba
Jajour, Nizar N.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Wisconsin, Dept Med, Madison, WI USAUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Jajour, Nizar N.
Mauad, Thais
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h-index: 0
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Univ Med Sch, Dept Pathol, Sao Paulo, BrazilUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Mauad, Thais
Sorkness, Ronald L.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Wisconsin, Dept Med, Madison, WI USAUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Sorkness, Ronald L.
Teague, W. Gerald
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h-index: 0
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Univ Virginia, Sch Med, Dept Paediat, Div Resp Med Allergy & Immunol, Charlottesville, VA 22903 USAUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
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Brigham & Womens Hosp, Boston, MA 02115 USA
Harvard Univ, Sch Med, Boston, MA USABrigham & Womens Hosp, Boston, MA 02115 USA
Dutile, Stefanie
Kaptchuk, Ted J.
论文数: 0引用数: 0
h-index: 0
机构:
Harvard Univ, Sch Med, Boston, MA USA
Beth Israel Deaconess Med Ctr, Program Placebo Studies, Boston, MA 02215 USABrigham & Womens Hosp, Boston, MA 02115 USA
Kaptchuk, Ted J.
Wechsler, Michael E.
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h-index: 0
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Natl Jewish Hlth, Div Pulm Crit Care & Sleep Med, Denver, CO 80206 USABrigham & Womens Hosp, Boston, MA 02115 USA
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Univ Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USAUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Fuhlbrigge, Anne L.
Bengtsson, Thomas
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h-index: 0
机构:
StatMind Stat & Math Modelling Innovat & Design A, Lund, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Bengtsson, Thomas
Peterson, Stefan
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h-index: 0
机构:
StatMind Stat & Math Modelling Innovat & Design A, Lund, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Peterson, Stefan
Jauhiainen, Alexandra
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h-index: 0
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AstraZeneca, Res & Dev, Early Clin Dev, Gothenburg, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Jauhiainen, Alexandra
Eriksson, Goran
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h-index: 0
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Lund Univ Hosp, Dept Resp Med & Allergol, Lund, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Eriksson, Goran
Da Silva, Carla A.
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h-index: 0
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AstraZeneca, Res & Dev, Early Clin Dev, Gothenburg, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Da Silva, Carla A.
Johnson, Anthony
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h-index: 0
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AstraZeneca, Res & Dev, Early Clin Dev, Gothenburg, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Johnson, Anthony
Sethi, Tariq
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h-index: 0
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AstraZeneca, Res & Dev, Early Clin Dev, Gothenburg, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Sethi, Tariq
Locantore, Nicholas
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h-index: 0
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GlaxoSmithKline Res & Dev Ltd, King Of Prussia, PA USAUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Locantore, Nicholas
Tal-Singer, Ruth
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h-index: 0
机构:
GlaxoSmithKline Res & Dev Ltd, King Of Prussia, PA USAUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Tal-Singer, Ruth
Fageras, Malin
论文数: 0引用数: 0
h-index: 0
机构:
Global Med Affairs, Global Product & Portfolio Strategy, Gothenburg, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
机构:
Univ London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Royal Brompton Hosp, Biomed Res Unit, London SW3 6LY, EnglandUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Chung, Kian Fan
Wenzel, Sally E.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Pittsburgh, Dept Med, Pittsburgh, PA USAUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Wenzel, Sally E.
Brozek, Jan L.
论文数: 0引用数: 0
h-index: 0
机构:
McMaster Univ, Dept Clin Epidemiol & Biostat & Med, Hamilton, ON, CanadaUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Brozek, Jan L.
Bush, Andrew
论文数: 0引用数: 0
h-index: 0
机构:
Univ London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Royal Brompton Hosp, Biomed Res Unit, London SW3 6LY, EnglandUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Bush, Andrew
Castro, Mario
论文数: 0引用数: 0
h-index: 0
机构:
Washington Univ, Dept Med, St Louis, MO USAUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Castro, Mario
Sterk, Peter J.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Amsterdam, Acad Med Ctr, Dept Resp Med, NL-1105 AZ Amsterdam, NetherlandsUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Sterk, Peter J.
Adcock, Ian M.
论文数: 0引用数: 0
h-index: 0
机构:
Univ London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, EnglandUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Adcock, Ian M.
Bateman, Eric D.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Cape Town, Lung Inst, ZA-7925 Cape Town, South AfricaUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Bateman, Eric D.
Bel, Elisabeth H.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Amsterdam, Acad Med Ctr, Dept Resp Med, NL-1105 AZ Amsterdam, NetherlandsUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Bel, Elisabeth H.
Bleecker, Eugene R.
论文数: 0引用数: 0
h-index: 0
机构:
Wake Forest Univ, Dept Med, Winston Salem, NC 27109 USAUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Bleecker, Eugene R.
Boulet, Louis-Philippe
论文数: 0引用数: 0
h-index: 0
机构:
Inst Univ Cardiol & Pneumol Quebec, Ctr Rech, Quebec City, PQ, CanadaUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Boulet, Louis-Philippe
Brightling, Christopher
论文数: 0引用数: 0
h-index: 0
机构:
Univ Leicester, Inst Lung Hlth, Leicester, Leics, EnglandUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Brightling, Christopher
Chanez, Pascal
论文数: 0引用数: 0
h-index: 0
机构:
Marseille Univ, Dept Malad Resp, Marseille, FranceUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Chanez, Pascal
Dahlen, Sven-Erik
论文数: 0引用数: 0
h-index: 0
机构:
Karolinska Inst, Inst Environm Med, S-10401 Stockholm, SwedenUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Dahlen, Sven-Erik
Djukanovic, Ratko
论文数: 0引用数: 0
h-index: 0
机构:
Univ Southampton, Sch Med, Southampton NIHR Resp Biomed Res Unit, Southampton, Hants, England
Southampton Gen Hosp, Southampton SO9 4XY, Hants, EnglandUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Djukanovic, Ratko
Frey, Urs
论文数: 0引用数: 0
h-index: 0
机构:
Univ Basel, Univ Childrens Hosp UKBB, Basel, SwitzerlandUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
机构:
John Hunter Hosp, Hunter Med Res Inst, Newcastle, NSW, AustraliaUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Gibson, Peter
Hamid, Qutayba
论文数: 0引用数: 0
h-index: 0
机构:
McGill Univ, Meakins Christie Labs, Montreal, PQ, CanadaUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Hamid, Qutayba
Jajour, Nizar N.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Wisconsin, Dept Med, Madison, WI USAUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Jajour, Nizar N.
Mauad, Thais
论文数: 0引用数: 0
h-index: 0
机构:
Univ Med Sch, Dept Pathol, Sao Paulo, BrazilUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Mauad, Thais
Sorkness, Ronald L.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Wisconsin, Dept Med, Madison, WI USAUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
Sorkness, Ronald L.
Teague, W. Gerald
论文数: 0引用数: 0
h-index: 0
机构:
Univ Virginia, Sch Med, Dept Paediat, Div Resp Med Allergy & Immunol, Charlottesville, VA 22903 USAUniv London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London SW3 6LY, England
机构:
Brigham & Womens Hosp, Boston, MA 02115 USA
Harvard Univ, Sch Med, Boston, MA USABrigham & Womens Hosp, Boston, MA 02115 USA
Dutile, Stefanie
Kaptchuk, Ted J.
论文数: 0引用数: 0
h-index: 0
机构:
Harvard Univ, Sch Med, Boston, MA USA
Beth Israel Deaconess Med Ctr, Program Placebo Studies, Boston, MA 02215 USABrigham & Womens Hosp, Boston, MA 02115 USA
Kaptchuk, Ted J.
Wechsler, Michael E.
论文数: 0引用数: 0
h-index: 0
机构:
Natl Jewish Hlth, Div Pulm Crit Care & Sleep Med, Denver, CO 80206 USABrigham & Womens Hosp, Boston, MA 02115 USA
机构:
Univ Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USAUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Fuhlbrigge, Anne L.
Bengtsson, Thomas
论文数: 0引用数: 0
h-index: 0
机构:
StatMind Stat & Math Modelling Innovat & Design A, Lund, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Bengtsson, Thomas
Peterson, Stefan
论文数: 0引用数: 0
h-index: 0
机构:
StatMind Stat & Math Modelling Innovat & Design A, Lund, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Peterson, Stefan
Jauhiainen, Alexandra
论文数: 0引用数: 0
h-index: 0
机构:
AstraZeneca, Res & Dev, Early Clin Dev, Gothenburg, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Jauhiainen, Alexandra
Eriksson, Goran
论文数: 0引用数: 0
h-index: 0
机构:
Lund Univ Hosp, Dept Resp Med & Allergol, Lund, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Eriksson, Goran
Da Silva, Carla A.
论文数: 0引用数: 0
h-index: 0
机构:
AstraZeneca, Res & Dev, Early Clin Dev, Gothenburg, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Da Silva, Carla A.
Johnson, Anthony
论文数: 0引用数: 0
h-index: 0
机构:
AstraZeneca, Res & Dev, Early Clin Dev, Gothenburg, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Johnson, Anthony
Sethi, Tariq
论文数: 0引用数: 0
h-index: 0
机构:
AstraZeneca, Res & Dev, Early Clin Dev, Gothenburg, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Sethi, Tariq
Locantore, Nicholas
论文数: 0引用数: 0
h-index: 0
机构:
GlaxoSmithKline Res & Dev Ltd, King Of Prussia, PA USAUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Locantore, Nicholas
Tal-Singer, Ruth
论文数: 0引用数: 0
h-index: 0
机构:
GlaxoSmithKline Res & Dev Ltd, King Of Prussia, PA USAUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA
Tal-Singer, Ruth
Fageras, Malin
论文数: 0引用数: 0
h-index: 0
机构:
Global Med Affairs, Global Product & Portfolio Strategy, Gothenburg, SwedenUniv Colorado, Sch Med, Dept Med, Pulm Sci & Crit Care, Denver, CO 80202 USA