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Article History

Received: 31 May 2019

Accepted: 29 November 2019

First Online: 11 December 2019

Ethics approval and consent to participate

: The PATRO Adults study protocol was approved by the ethics review committee of all participating centers in accordance with national laws and regulations. Written informed consent was obtained from all participating patients.The study was approved by the following ethics committees:<b><i>Czech Republic</i></b><i>:</i> Etická komise Všeobecné fakultní nemocnice v Praze, 128 08 Praha 2; Multicentrická etická komise Fakultní nemocnice Hradec Králové, 500 05 Hradec Králové. <b><i>Germany</i></b><i>:</i> Medical Council of Bavaria Ethics Committee, 81677 München; Medical Council of Hamburg Ethics Committee, 22083 Hamburg; Medical Council of Saxony Ethics Committee, 01099 Dresden; Medical Council of Thuringia Ethics Committee, 07751 Jena; Ärztekammer Hessen, 60488 Frankfurt am Main; Medical Council of Lower Saxony Ethics Committee, 30175 Hannover; Medical Faculty of University of Hannover Ethics Committee, 30625 Hannover; Medical Faculty of University of Würzburg Ethics Committee, 97078 Würzburg; Medical Faculty of University of Tübingen Ethics Committee, 72074 Tübingen; Medical Faculty of University of Erlangen Ethics Committee, 91054 Erlangen; Medical Council of Westphalia-Lippe Ethics Committee, 48147 Münster; Medical Council of Baden-Wurttemberg Ethics Committee, 70597 Stuttgart; Medical Faculty of University of Aachen Ethics Committee, 52074 Aachen; Medical Council of Berlin Ethics Committee, 10707 Berlin; Ethikkommission an der Medizinischen Fakultät der Universität Leipzig, 04109 Leipzig, Germany; Medical Faculty of Ludwig-Maximilian University Munich Ethics Committee, 80336 Munich; Bayerische Landesärztekammer, 81677 München. <b><i>Spain</i></b><i>:</i> Comité de Ética de Investigación de los Hospitales Universitarios Virgen Macarena - Virgen del Rocio, 41013 Sevilla; Comité Ético de Investigación Clínica Hospital Universitari Vall d’Hebron, 08035 Barcelona. <b><i>UK</i></b><i>:</i> NRES Committee South Central - Southampton A, Bristol BS1 2NT. <b><i>Italy</i></b>: Comitato di Etica Della Fondazione Irccs ca’ Granda Ospedale Maggiore, 20122 MILANO; Comitato Etico Dell’Azienda Ospedaliera Universitaria S. Martino Di Genova, 16132 GENOVA; Comitato Etico Dell’Azienda Ospedaliera Universitaria S. Giovanni Battista Di Torino, 10126 TORINO; Comitato Etico di Area Vasta Emilia Centro (CE-AVEC) c/o Ufficio Ricerca e Innovazione, Azienda Ospedaliero Universitaria di Ferrara, 44121 FERRARA; Comitato Etico Delle Aziende Sanitarie Dell’Umbria; Segreteria Scientifico Amministrativa, 06073 PERUGIA; Comitato Etico per le attività biomediche “Carlo Romano”, dell’Università degli Studi di Napoli Federico II, Segreteria tecnico-scientifica, 80131 NAPOLI; Comitato Etico Dell’Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Di Ancona, 60126 ANCONA; Comitato Etico Per La Sperimentazione Dell’Azienda Ospedaliera Di Padova, 35128 PADOVA. <b><i>The Netherlands</i></b><i>:</i> METC Isala, 8000 GK Zwolle; Wetenschapsbureau, 1815 GM Alkmaar. <b><i>Sweden</i></b><i>:</i> Regionala Etikprövningsnämnden i Stockholm, 171 77 Stockholm<i>.</i><b><i>France:</i></b> Institut National des Données de Santé, 94220 Charenton-le-Pont; Comité Consultatif pour le Traitement de l’Information en matière de Recherche pour la Santé, 75231 Paris cedex 05.

: As part of the informed consent process, all patients provided written consent for the publication of data collected in the study.

: CH has acted as an investigator for Sandoz, Pfizer and Novo Nordisk; has received lecture fees from Sandoz, Pfizer and Novo Nordisk; and is a member of the global steering committee for the PATRO Adults study. RM has received research funding from Sandoz, Ipsen and Pfizer; has received lecture fees from Pfizer; and is a member of the global steering committee for the PATRO Adults study. PB-P and SS are members of the global steering committee for the PATRO Adults study. GS has received honoraria for scientific advisory work and/or reimbursement of delegate fees for congresses/seminars and/or travel costs and/or research grants from the HRA, Ipsen, Lilly, Novartis, Novo Nordisk, Pfizer, Sandoz and Shire; and is a member of the global steering committee for the PATRO Adults study. HZ and MZ are employees of Sandoz Biopharmaceutical, c/o HEXAL AG.