Ethics approval and consent to participate
Ethik-Kommission der, Ethik-Kommission der Medizinischen, Ethik-Kommission II der, Geschäftsstelle der Ethik-Kommission des, der, Cancer
DEL, DER, WEST, CANCER
The study complies with International Conference for Harmonisation (of Technical Requirements for Pharmaceuticals for Human Use) E6(R2) Good Clinical Practice, and applicable local laws and regulations. The study protocol was reviewed and approved by the institutional review boards and independent ethics committees at all participating study sites. Ethics approval was obtained from the following institutional review boards and independent ethics committees: Bellberry Human Research Ethics Committee, Saint Vincent's Hospital Sydney, Sir Charles Gairdner Hospital, Westmead Hospital, Ethik-Kommission der Medizinischen Universität Wien, Ethikkommission des Landes Kaernten, Hôpital Erasme, Advarra IRB Columbia—Maryland Headquarters, Biomedical Research Ethics Board (BREB), Conjoint Health Research Ethics Board (CHREB), Hamilton Integrated Research Ethics Board, McGill University Health Centre, Research Ethics Board, North York General Hospital, Nova Scotia Health Authority, Research Ethics Board for Health Sciences Research Involving Human Subjects, University Health Network Research Ethics Board, University of British Columbia, Clinical Research Ethics Board, William Osler Health System Research Ethics Board, The Scientific Ethics Comities for Region Capital, TUKIJA National Committee on Medical Research Ethics, Comité de Protection des Personnes Ile de France III, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig, Ethikkommission der Ärztekammer des Saarlandes, Ethikkommission der Christian-Albrechts-Universität zu Kiel, Ethikkommission der Friedrich-Schiller-Universität Jena, Ethik-Kommission der Landesärztekammer Rheinland-Pfalz, Ethik-Kommission der Medizinischen Fakultät Heidelberg, Ethikkommission der Medizinischen Hochschule Hannover, Ethikkommission der Medizinischen, Fakultat Essen Institut fur Pharmakologie Universitatsklinikum, Ethikkommission des Fachbereichs Medizin der Johann Wolfgang Goethe-Universität Frankfurt, Ethik-Kommission II der Medizinischen Fakultät Mannheim der Universität Heidelberg, Landesamt für Gesundheit und Soziales Berlin, Geschäftsstelle der Ethik-Kommission des Landes Berl, Carmel Medical Center Helsinki Committee, Emek Medical Center, Hadassah University Hospital Ethics Helsinki Committee, Rabin Medical Center Ethics Helsinki Committee, Rambam Health Care Campus Ethics Helsinki Committee, Shaare Zedek Medical Center, Institutional Review Board, Tel Aviv Sourasky Medical Center Ethics Helsinki Committee, The Chaim Sheba Medical Center Ethics Helsinki Committee, A.O.U. Policlinico Paolo Giaccone, Azienda Ospedaliera Policlinico di Modena, Comitato Etico Provinciale di Modena, Comitato Etico dell’Università Cattolica del Sacro Cuore Policlinico Universitario Agostino Gemel, Comitato Etico della Provincia Monza Brianza, Comitato Etico dell'Azienda Ospedaliera Ospedali Riuniti di Foggia, Comitato Etico dell'IRCCS Istituto Clinico Humanitas, Comitato Etico Interaziendale Novara, Comitato Etico Milano Area 2, Comitato Etico per la Sperimentazione Clinica della Provincia di Padova, Comitato Etico Regionale delle Marche, Chiba University Hospital, Ehime University Hospital Institutional Review Board, Hiroshima University hospital IRB, Juntendo University Hospital, Nagasaki Medical Center, Okayama University Hospital, Osaka University Hospital, Teikyo University Hospital, Tohoku University Hospital Institutional Review Board, Yamagata University Hospital, Health and Disability Committees, Hospital General Universitario Gregorio Marañon, Research Ethics Committee—South Central—Hampshire A, Advarra IRB Columbia—Maryland Headquarters, Baylor Institutional Review Board, Baylor Scott and White Research Institute, Brany-IRB, Cedars-Sinai Medical Center, Institutional Review Board, Cleveland Clinic Foundation, Institutional Review Board, Columbia University Medical Center Institutional Review Board, Committee on Clinical Investigation Beth Israel Deaconess Medical Center, Duke University Health System Institutional Review Board, Georgetown University Institutional Review Board, Henry Ford Health System Institutional Review Board, Human Research Protection Program—Health Science Committee, Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects, Intermountain Healthcare—Institutional Review Board, IRBMED, Kansas University Medical Center, Human Subjects Committee, Mayo Clinic, Institutional Review Board, Medical University of South Carolina, Institutional Review Board for Human Subjects, Mercy Medical Center, Institutional Review Board, NYU IRB, Ochsner Institutional Review Board, Penn State College of Medicine Institutional Review Board, Reading Hospital Occupational Health Services—West Reading, Regional Health Command-Central Institutional Review Board, Rush University Medical Center Institutional Review Board, Office of Research Affairs, UCLA Office of the Human Research Protection Program, University of California at Davis, Office of Human Research Protection, University of Chicago Biological Sciences Division IRB, University of Tennessee Health Science Center IRB, University of Utah IRB, University of Vermont, Research Protections Office, Committees on Human Research, University of Virginia Institutional Review Board for Health Sciences Research, Walter Reed National Military Medical Center IRB, Weill Cornell Medical College—Sandra and Edward Meyer Cancer Center, Western Institutional Review Board, and Western IRB, Yale—New Haven Hospital. Informed consent is obtained from all individual participants. The study was designed and conducted by the sponsor (Gilead Sciences, Inc., Foster City, CA, USA) in collaboration with the principal investigators according to the protocol.