Keith Lasher and the Janssen Global Clinical Organization for management of the ADEPT clinical trial. The investigators who participated in the ADEPT study: I. Strambu, Arensia Exploratory Medicine, Sos. Viilor 90, Bucharest 050159, Romania; M. Laviolette, Institut Universitaire de Cardiologie et Pneumologie de Québec (IUCPQ), 2725, Chemin Ste-Foy, Québec G1V 4G5, Canada; D. Singh, Medicines Evaluation Unit, University Hospital of South Manchester Foundation Trust, University of Manchester, Southmoor Road, Manchester M23 9QZ, UK; J. M. FitzGerald, Institute for Heart and Lung Health, The Lung Centre, 7th Floor, Gordon, Canada & Leslie Diamond Health Care Centre, 2775 Laurel Street, Vancouver, BC V5Z 1 M9, Canada; S. Lam, Institute for Heart and Lung Health, The Lung Centre, 7th Floor, Gordon, Canada & Leslie Diamond Health Care Centre, 2775 Laurel Street, Vancouver, BC V5Z 1 M9, Canada; S. Kelsen, Temple University Hospital, 3401 N. Broad Street, Philadelphia, PA 19140, USA; A. Eich, IKF Pneumologie Frankfurt, Institut für klinische Forschung Pneumologie, Clinical Research Centre Respiratory Diseases, Schaumainkai 101–103, Stresemannallee, 360596 Frankfurt, Germany; A. Ludwig-Sengpiel, KLB Gesundheitsforschung Lübeck GmbH, Sandstr. 18, 23552 Lübeck, Germany; G. C hupp, Yale School of Medicine, TAC 441, 300 Cedar Street, New Haven, CT 06520,USA; V. Backer, Department of Respiratory Medicine, Respiratory Research Unit, Bispebjerg University Hospital, Bispebjerg bakke 23, DK-2400 Copenhagen,NV, Denmark; C. Porsbjerg, Department of Respiratory Medicine, Respiratory Research Unit, Bispebjerg University Hospital, Bispebjerg bakke 23, DK-2400 Copenhagen,NV, Denmark; P. O. Girodet, Univ. Bordeaux, Centre de Recherche Cardio-Thoracique de Bordeaux, U1045, CIC 1401, F-33000 Bordeaux, France; P. Berger, Univ. Bordeaux, Centre de Recherche Cardio-Thoracique de Bordeaux, U1045, CIC 1401, F-33000 Bordeaux, France; R. Leigh, Cumming School of Medicine, University of Calgary, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada; J. Kline, Division of Pulmonary, Critical Care, and Occupational Medicine, University of Iowa, W219B GH UIHC, 200 Hawkins Drive, Iowa City, IA 52242, USA; M. Dransfield, Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham & Birmingham VA Medical Center, 422 THT, 1900 University Blvd, Birmingham, AL 35294, USA; W. Calhoun, 116 John Sealy Annex, University of Texas Medical Branch, 301 University Blvd, Galveston, TX 77555–0568, USA; A. Hussaini, Parexel International, Shelton Simmons (MD), 3001 S Hanover St #7, Brooklyn, MD 21225, USA; S. Khatri, Department of Pulmonary and Critical Care, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA; P. Chanez, Pneumologie, Aix Marseille University, APHM/ INSERM U1067, Chemin des Bourellys, 13015 Marseille, France. U-BIOPRED has been funded by a public-private grant from the Innovative Medicines Initiative (IMI) provided by the European Union (EU) and the European Federation of Pharmaceutical Industries and Associations.U-BIOPRED has been funded by a public-private grant from the Innovative Medicines Initiative (IMI) provided by the European Union (EU) and the European Federation of Pharmaceutical Industries and Associations. The members of the U-BIOPRED Study Group are as follows:
Adcock Ian, National Heart and Lung Institute, Imperial College, London, UK;
Adriaens Nora, Academic Medical Centre, University of Amsterdam, The Netherlands;
Ahmed Hassan, European Institute for Systems Biology and Medicine, CNRS-ENS-UCBL-INSERM, Lyon, France;
Aliprantis Antonios, Merck Research Laboratories, Boston, USA;
Alving Kjell, Dept Women’s & Children’s Health, Uppsala University, Sweden
Auffray Charles, European Institute for Systems Biology and Medicine, CNRS-ENS-UCBL-INSERM, Lyon, France;
Badorrek Philipp, Fraunhofer ITEM; Cornelia Faulenbach, Fraunhofer ITEM;
Bakke Per, Department of Clinical Science, University of Bergen, Bergen, Norway;
Balgoma David, Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Bansal Aruna T., Acclarogen Ltd, St. John’s Innovation Centre, Cambrigde, UK;
Barber Clair, NIHR Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, Southampton, UK;
Baribaud Frédéric, Janssen R&D, USA;
Bautmans An, MSD, Brussels, BE
Behndig Annelie F., Dept of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden;
Bel Elisabeth, Academic Medical Centre, University of Amsterdam, The Netherlands;
Beleta Jorge, Almirall S.A., Barcelona, Spain;
Berglind Ann, Dept. Women’s and Children’s Health & Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Berton Alix, AstraZeneca, Mölndal, Sweden
Bigler Jeannette, Previously at: Amgen Inc.;
Bisgaard Hans, COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital,
University of Copenhagen, Copenhagen, Denmark
Bochenek Grazyna, II Department of Internal Medicine, Jagiellonian University Medical College, Krakow, Poland;
Boedigheimer Michel J., Amgen Inc.;
Bøonnelykke Klaus, COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte
Hospital, University of Copenhagen, Copenhagen, Denmark;
Brandsma Joost, University of Southampton, UK
Braun Armin, Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany;
Brinkman Paul, Academic Medical Centre, University of Amsterdam, The Netherlands;
Burg Dominic, Centre for Proteomic Research, Institute for Life Sciences, University of Southampton, UK
Campagna Davide, Department of Clinical and Experimental Medicine, University of Catania, Italy;
Carayannopoulos Leon, MSD, USA;
Caruso Massimo, Dept. Clinical and Experimental Medicine, University of Catania, Italy;
Carvalho da Purificação Rocha João Pedro, Royal Brompton and Harefield NHS Foundation Trust, UK;
Chaiboonchoe Amphun, European Institute for Systems Biology and Medicine, CNRS-ENS-UCBL-INSERM, CIRI-UMR5308, Lyon, France;
Chaleckis Romanas, Centre of Allergy Research, Karolinska Institutet, Stockholm, Sweden
Chanez Pascal, Assistance publique des Hôpitaux de Marseille - Clinique des bronches, allergies et sommeil, Aix Marseille Université, Marseille France
Chung Kian F., National Heart and Lung Institute, Imperial College, London, UK;
Coleman Courtney, Asthma UK, London, UK;
Compton Chris, Respiratory Therapeutic Unit, GSK, UK
Corfield Julie, Areteva R&D, Nottingham, UK;
D’Amico Arnaldo, University of Rome ‘Tor Vergata’, Rome Italy;
Dahlen Barbro, Karolinska University Hospital & Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Dahlén Sven-Erik, Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
De Alba Jorge, Almirall S.A., Barcelona, Spain;
de Boer Pim, Longfonds, Amersfoort, The Netherlands;
De Lepeleire Inge, MSD, Brussels, BE
De Meulder Betrand, European Institute for Systems Biology and Medicine, CNRS-ENS-UCBL-INSERM, Lyon, France;
Dekker Tamara, Academic Medical Centre, University of Amsterdam, The Netherlands;
Delin Ingrid, Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Dennison Patrick, NIHR Southampton Respiratory Biomedical Research Unit, Clinical and Experimental Sciences, NIHR-Wellcome Trust Clinical Research Facility, Faculty of Medicine, University of Southampton, UK;
Dijkhuis Annemiek, Academic Medical Centre, University of Amsterdam, The Netherlands;
Djukanovic Ratko, NIHR Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, Southampton, UK;
Draper Aleksandra, BioSci Consulting, Maasmechelen, Belgium;
Edwards Jessica, Asthma UK, London, UK;
Emma Rosalia, Department of Clinical and Experimental Medicine, University of Catania, Italy;
Ericsson Magnus, Karolinska University Hospital, Stockholm, Sweden
Erpenbeck Veit, Translational Medicine, Respiratory Profiling, Novartis Institutes for Biomedical Research, Basel, Switzerland;
Erzen Damijan, Boehringer Ingelheim Pharma GmbH & Co. KG; Biberach, Germany
Fichtner Klaus, Boehringer Ingelheim Pharma GmbH & Co. KG; Biberach, Germany
Fitch Neil, BioSci Consulting, Maasmechelen, Belgium;
Fleming Louis J., National Heart and Lung Institute, Imperial College, London, UK;
Flood Breda, Asthma UK, UK;
Fowler Stephen J., Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, University of Manchester and University Hospital of South Manchester, Manchester Academic Health Sciences Centre, Manchester, United Kingdom
Frey Urs, University Children’s Hospital, Basel, Switzerland;
Gahlemann Martina, Boehringer Ingelheim (Schweiz) GmbH, Switzerland;
Galffy Gabriella, Semmelweis University, Budapest, Hungary;
Gallart Hector, Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Garrett Trevor, BioSci Consulting, Maasmechelen, Belgium;
Geiser Thomas, Department of Respiratory Medicine, University Hospital Bern, Switzerland;
Gent Julaiha, Royal Brompton and Harefield NHS Foundation Trust, UK;
Gerhardsson de Verdier Maria, AstraZeneca; Molndal, Sweden;
Gibeon David, National Heart and Lung Institute, Imperial College, UK;
Gomez Cristina, Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Gove Kerry, NIHR Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, Southampton, UK;
Gozzard Neil, UCB, UK;
Guo Yi-ke, Data Science Institute, Imperial College, UK;
Hashimoto Simone, Academic Medical Centre, University of Amsterdam, The Netherlands;
Haughney John, International Primary Care Respiratory Group, Aberdeen, Scotland;
Hedlin Gunilla, Dept. Women’s and Children’s Health & Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden;
Hekking Pieter-Paul, Academic Medical Centre, University of Amsterdam, The Netherlands;
Henriksson Elisabeth, Karolinska University Hospital & Karolinska Institutet, Stockholm, Sweden
Hewitt Lorraine, NIHR Southampton Respiratory Biomedical Research Unit, Southampton, UK
Higgenbottam Tim, Allergy Therapeutics, West Sussex, UK;
Hoda Uruj, Imperial College, UK;
Hohlfeld Jens, Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany;
Holweg Cecile, Respiratory and Allergy Diseases, Genentech, San Francisco CA;
Horvath Ildiko, Semmelweis University, Budapest, Hungary;
Howarth Peter, NIHR Southampton Respiratory Biomedical Research Unit, Clinical and Experimental Sciences and Human Development and Health, Southampton, UK;
Hu Richard, Amgen Inc.;
Hu Sile, National Heart and Lung Institute, Imperial College, UK;
Hu Xugang, Amgen Inc.;
Hudson Val, Asthma UK, London, UK;
James Anna J., Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden;
Kamphuis Juliette, Longfonds, Amersfoort, The Netherlands;
Kennington Erika J., Asthma UK, London, UK;
Kerry Dyson, CromSource, Stirling UK;
Klüglich Matthias, Boehringer Ingelheim Pharma GmbH & Co. KG; Biberach, Germany
Knobel Hugo, Philips Research Laboratories, Eindhoven, The Netherlands;
Knowles Richard, Arachos Pharma, UK;
Knox Alan, Respiratory Research Unit, University of Nottingham, UK;
Kolmert Johan, Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Konradsen Jon, Dept. Women’s and Children’s Health & Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Kots Maxim, Chiesi Pharmaceuticals, SPA, Parma, Italy;
Krueger Linn, University Children’s Hospital Bern, Switzerland
Krug Norbert, Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany;
Kuo Scott, National Heart and Lung Institute, Imperial College, UK;
Kupczyk Maciej, Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Lambrecht Bart, University of Gent, Gent, Belgium;
Lantz Ann-Sofie, Karolinska University Hospital & Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden;
Larsson Lars, AstraZeneca, Mohlndal, Sweden;
Lazarinis Nikos, Karolinska University Hospital & Karolinska Institutet, Stockholm, Sweden
Lefaudeux Diane, European Institute for Systems Biology and Medicine, CNRS-ENS-UCBL-INSERM, Lyon, France;
Lone-Latif Saeeda, Academic Medical Centre, University of Amsterdam, The Netherlands;
Loza Matthew J., Janssen R&D, USA;
Lutter Rene, Academic Medical Centre, University of Amsterdam, The Netherlands;
Marouzet Lisa, NIHR Southampton Respiratory Biomedical Research Unit, Southampton, UK
Martin Jane, NIHR Southampton Respiratory Biomedical Research Unit, Southampton, UK
Masefield Sarah, European Lung Foundation, Sheffield, UK;
Mathon Caroline, Centre of Allergy Research, Karolinska Institutet, Stockholm, Sweden
Matthews John G., Respiratory and Allergy Diseases, Genentech, San Francisco CA, USA;
Mazein Alexander, European Institute for Systems Biology and Medicine, CNRS-ENS-UCBL-INSERM, CIRI-UMR5308, Lyon, France;
Meah Sally, National Heart and Lung Institute, Imperial College, UK;
Meiser Andrea, National Heart and Lung Institute, Imperial College, UK;
Menzies-Gow Andrew, Royal Brompton and Harefield NHS Foundation Trust, UK;
Metcalf Leanne, Previously at: Asthma UK, London, UK;
Middelveld Roelinde, Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Mikus Maria, Science for Life Laboratory & The Royal Institute of Technology, Stockholm, Sweden;
Miralpeix Montse, Almirall, Barcelona, Spain;
Monk Philip, Synairgen Research Ltd, Southampton, UK;
Montuschi Paolo, Università Cattolica del Sacro Cuore, Italy;
Mores Nadia, Università Cattolica del Sacro Cuore, Italy;
Murray Clare S., Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, University of Manchester and University Hospital of South Manchester, Manchester Academic Health Sciences Centre, Manchester, United Kingdom
Musial Jacek, II Department of Internal Medicine, Jagiellonian University Medical College, Krakow, Poland;
Myles David, Respiratory Therapeutic Unit, GSK, UK;
Naz Shama, Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Nething Katja, Boehringer Ingelheim Pharma GmbH & Co. KG; Biberach, Germany
Nicholas Ben, University of Southampton, UK
Nihlen Ulf, AstraZeneca; Molndal, Sweden;
Nilsson Peter, Science for Life Laboratory & The Royal Institute of Technology, Stockholm, Sweden;
Nordlund Björn, Dept. Women’s and Children’s Health & Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Östling Jörgen, AstraZeneca, Mölndal, Sweden;
Pacino Antonio, Lega Italiano Anti Fumo, Catania, Italy;
Pahus Laurie, Assistance publique des Hôpitaux de Marseille, Clinique des bronches, allergies et sommeil
Espace Éthique Méditerranéen, Aix-Marseille Université, Marseille, France;
Palkonen Susanna, European Federation of Allergy and Airways Diseases Patient’s Associations, Brussels, Belgium.
Pandis Ioannis, Data Science Institute, Imperial College, London, UK;
Pavlidis Stelios, National Heart and Lung Institute, Imperial College, UK
Pennazza Giorgio, University of Rome ‘Tor Vergata’, Rome Italy;
Petrén Anne, Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Pink Sandy, NIHR Southampton Respiratory Biomedical Research Unit, Southampton, UK
Postle Anthony, University of Southampton, UK
Powel Pippa, European Lung Foundation, Sheffield, UK;
Rahman-Amin Malayka, Previously at: Asthma UK, London, UK;
Rao Navin, Janssen R&D, USA;
Ravanetti Lara, Academic Medical Centre, University of Amsterdam, The Netherlands;
Ray Emma, NIHR Southampton Respiratory Biomedical Research Unit, Southampton, UK
Reinke Stacey, Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Reynolds Leanne, Previously at: Asthma UK, London, UK;
Riemann Kathrin, Boehringer Ingelheim Pharma GmbH & Co. KG; Biberach, Germany
Riley John, Respiratory Therapeutic Unit, GSK, UK;
Robberechts Martine, MSD, Brussels, BE
Roberts Amanda, Asthma UK, UK;
Roberts Graham, NIHR Southampton Respiratory Biomedical Research Unit, Clinical and Experimental Sciences and Human Development and Health, Southampton, UK;
Rossios Christos, National Heart and Lung Institute, Imperial College, UK;
Rowe Anthony, Janssen R&D, UK;
Russell Kirsty, National Heart and Lung Institute, Imperial College, UK;
Rutgers Michael, Longfonds, Amersfoort, The Netherlands;
Sandström Thomas, Dept of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden;
Santini Giuseppe, Università Cattolica del Sacro Cuore, Italy;
Santoninco Marco, University of Rome ‘Tor Vergata’, Rome Italy;
Schoelch Corinna, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
Schofield James P. R., Centre for Proteomic Research, Institute for Life Sciences, University of Southampton, UK
Seibold Wolfgang, Boehringer Ingelheim Pharma GmbH, Biberach, Germany
Shaw Dominick E., Respiratory Research Unit, University of Nottingham, UK;
Sigmund Ralf, Boehringer Ingelheim Pharma GmbH & Co. KG; Biberach, Germany
Singer Florian, University Children’s Hospital, Zurich, Switzerland;
Sjödin Marcus, Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Skipp Paul J., Centre for Proteomic Research, Institute for Life Sciences, University of Southampton, UK
Smids Barbara, Academic Medical Centre, University of Amsterdam, The Netherlands;
Smith Caroline, NIHR Southampton Respiratory Biomedical Research Unit, Southampton, UK
Smith Jessica, Asthma UK, London, UK;
Smith Katherine M., University of Nottingham, UK;
Söderman Päivi, Dept. Women’s and Children’s Health, Karolinska Institutet, Stockholm, Sweden
Sogbesan Adesimbo, Royal Brompton and Harefield NHS Foundation Trust, UK;
Sousa Ana R., Respiratory Therapeutic Unit, GSK, UK;
Staykova Doroteya, University of Southampton, UK
Sterk Peter J., Academic Medical Centre, University of Amsterdam, The Netherlands;
Strandberg Karin, Karolinska University Hospital & Karolinska Institutet, Stockholm, Sweden
Sun Kai, National Heart and Lung Institute, Imperial College, UK;
Supple David, Asthma UK, UK;
Szentkereszty Marton, Semmelweis University, Budapest, Hungary;
Tamasi Lilla, Semmelweis University, Budapest, Hungary;
Tariq Kamran, NIHR Southampton Respiratory Biomedical Research Unit, Clinical and Experimental Sciences, NIHR-Wellcome Trust Clinical Research Facility, Faculty of Medicine, University of Southampton, UK;
Thörngren John-Olof, Karolinska University Hospital, Sweden
Thornton Bob, MSD, USA;
Thorsen Jonathan, COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte
Hospital, University of Copenhagen, Copenhagen, Denmark;
Valente Salvatore, Università Cattolica del Sacro Cuore, Italy;
van Aalderen Wim, Academic Medical Centre, University of Amsterdam, The Netherlands;
van de Pol Marianne, Academic Medical Centre, University of Amsterdam, The Netherlands;
van Drunen Kees, Academic Medical Centre, University of Amsterdam, The Netherlands;
van Geest Marleen, AstraZeneca, Mölndal, Sweden;
Versnel Jenny, Previously at: Asthma UK, London, UK;
Vestbo Jorgen, Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, University of Manchester and University Hospital of South Manchester, Manchester Academic Health Sciences Centre, Manchester, United Kingdom
Vink Anton, Philips Research Laboratories, Eindhoven, The Netherlands;
Vissing Nadja, COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital,
University of Copenhagen, Copenhagen, Denmark;
von Garnier Christophe, University Hospital Bern, Switzerland;
Wagener Ariane, Academic Medical Centre, University of Amsterdam, The Netherlands;
Wagers Scott, BioSci Consulting, Maasmechelen, Belgium;
Wald Frans, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
Walker Samantha, Asthma UK, London, UK;
Ward Jonathan, Histochemistry Research Unit, Faculty of Medicine, University of Southampton, Southampton, UK;
Weiszhart Zsoka, Semmelweis University, Budapest, Hungary;
Wetzel Kristiane, Boehringer Ingelheim Pharma GmbH, Biberach, Germany
Wheelock Craig E., Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden;
Wiegman Coen, National Heart and Lung Institute, Imperial College, UK;
Williams Siân, International Primary Care Respiratory Group, Aberdeen, Scotland;
Wilson Susan J., Histochemistry Research Unit, Faculty of Medicine, University of Southampton, Southampton, UK;
Woodcock Ashley, Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, University of Manchester and University Hospital of South Manchester, Manchester Academic Health Sciences Centre, Manchester, United Kingdom
Yang Xian, National Heart and Lung Institute, Imperial College, UK;
Yeyasingham Elizabeth, UK Clinical Operations, GSK, Stockley Park, UK;
Yu Wen, Amgen Inc.;
Zetterquist Wilhelm, Dept. Women’s and Children’s Health & Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Zwinderman Koos, Academic Medical Centre, University of Amsterdam, The Netherlands;
Funding
Janssen R&D LLC (ADEPT), Innovative Medicine Initiative (U-BIOPRED).
Availability of data and material
For the review process we will make the ADEPT clinical data base available to the reviewers as well as a spreadsheet which allows to classify new patients. If published we will not as of now share the data because of our contractual agreement with the investigators of the study.
Author’s contributions
Conception and design: MJL, RD, KFC, ESB, VSS, PES, PJS, FB; Acquisition of data: DH, KM, PB; Analysis and Interpretation: MJL, RD, KFC, PB, ESB, PES, PJS, FB; Drafting the manuscript for important intellectual content: MJL, PES, RD, FB; Critical revisions: All authors; Approval of the final version: All authors.
Competing interests
MJL, DH, KM, PB, ESB, VSS and FB are current employees and shareholders of Janssen R&D, LLC. Philip E. Silkoff is a former employee and shareholder of Janssen R&D, LLC.
Consent for publication
All participants provided written informed consent which included permission to publish the study findings in both ADEPT (NCT01274507) and UBIOPRED (NCT01982162).
Ethics approval and consent to participate
Both studies complied with the Principles of the Declaration of Helsinki and had ethics approval by the respective institutional review boards. All participants provided written informed consent. Both studies complied with the Principles of the Declaration of Helsinki and had ethics approval by the respective institutional review boards. All subjects provided written informed consent to participate (genomic DNA testing was optional). The clinicaltrials.gov identifier are NCT01274507 (ADEPT) and NCT01982162 (U-BIOPRED).