Pedrosa, David J. http://orcid.org/0000-0002-5403-1959
Gandor, Florin
Jost, Wolfgang H.
Arlt, Carolin
Onuk, Koray
Timmermann, Lars
Article History
Received: 12 December 2021
Accepted: 23 February 2022
First Online: 15 March 2022
Declarations
:
: The study was approved by local ethics committees and performed according to the International Conference on Harmonization and Good Clinical Practice requirements. The principles of the Declaration of Helsinki were adhered to throughout the entire trial. The local ethics committees that provided approval included those in Austria (Ethik Kommission des Landes Oberösterreich, Ethikkommission der Medizinischen Universität Innsbruck, Ethik Kommission des Bundeslandes Niederösterreichs), in Belgium (Universitair Ziekenhuis Antwerpen), in Canada (REB of Centre intégré de santé et de services sociaux de Chaudière-Appalach [MSSS pour les centres du Québec], Health Research Ethics Boards [UofA], Western University Health Science REB [HSREB], MSSS [authorized by MUHC], Ottawa Health Science Network REB, Conjoint Health Research Ethics Board of the University of Calgary, Queen’s University Health Sciences & Affiliated teaching hospitals REB [HSREB], University Health Network REB, IRB Services [Advarra], REB Horizon Health Network, MSSS [authorized by JGH], IRB Services [Advarra]), in Switzerland (Ethikkommission Ostschweiz Kantonsspital), in Germany (Ethikkommission der Universität zu Köln, Ethikkommission der Landesärztekammer Brandenburg, Ethikkommission Ärztekammer Niedersachsen, Ethikkommission der Ländesärztekammer Thüringen, Ethik-Kommission Landesärztekammer Baden-Württemberg, Ethik-Kommission Albert-Ludwigs-Universität Freiburg, Ethik-Kommission der Ärztekammer Berlin, Ethikkommission Ärztekammer Nordrhein, Ethik-Kommission der Bayerischen Landesärztekammer, Ethikkommission der Ärztekammer Hamburg, Ethikkommission Ärztekamer Niedersachsen, Ethik-Kommission Rheinische Friedrich-Wilhelms-Universität Medizinische Fakultät, Ethikkommission Ärztekammer Sachsen-Anhalt, Ethikkommission Ärztekammer Niedersachsen, Ethikkommission Ärztekammer Nordrhein), in Greece (Ethics Committee of General Hospital of Thessaloniki “G. Papanikolaou”, Ethics Committee of General Hospital of Thessaloniki “Papageorgiou”, Ethics Committee of 251 Airforce General Hospital, Ethics Committee of Naval Hospital of Athens, Ethics Committee of University General Hospital “Attikon”, Ethics Committee of University General Hospital of Heraklion, Ethics Committee of University General Hospital of Patras, Ethics Committee of Mediterraneo Hospital, Ethics Committee of University General Hospital of Alexandroupoli, Ethics Committee of HYGEIA Hospital, Ethics Committee of General Hospital of Athens “G. Gennimatas”, Ethics Commmittee of University General Hospital of Thessaloniki “Axepa”, Ethics Committee of University General Hospital of Ioannina, Ethics Committee of 417 Nursing Institution of Participial Army Fund [NIMTS]), in Ireland (Education and Research Committee St Vincent’s University Hospital, Joint Research Ethics Committee SJH/AMNCH, Clinical Research Ethics Committee of the Cork Teaching Hospitals, Galway research ethics committee), in Israel (E. Wolfson Medical Center Helsinki Committee, IRB Committee Sheba Medical Center Israel, Tel Aviv Sourasky Medical Center Institutional Review Board, Ethics committee of Rabin Medical Center), in Italy (Comitato Etico delle Aziende Sanitarie dell’Umbria di Perugia, Comitato Etico Regional [CER] delle Marche c/o AUO Ospedali Riuniti, Comitato Etico AOU di Cagliari, Comitato Etico Indipendente Azienda Ospedaliero Universitaria Policlinico Consorziale di Bari, Comitato Etico Interaziendale AOU Città della Salute e della Scienza di Torino AO Ordine Mauriziano – ASL TO1, Comitato Etico Interaziendale della Provincia di Messina AOU Policlinico “G Martino”, Comitato Etico Area Vasta Centro c/o AOU Careggi, Comitato Etico Indipendente dell’Azienda Ospedaliera Universitaria Policlinico Tor Vergata di Roma, Comitato Etico Seconda Università degli Studi di Napoli Azienda Ospedaliera Universitaria SUN-AORN “Ospedali dei Colli”), in Turkey (Kocaeli University Medical Faculty Ethics Committee), in the Czech Republic (Ethics Committee of the General Hospital of Charles University in Prague, Ethics Committee of the St Anna Hospital of Masaryk University in Brno), in Slovakia (the local legislation valid at that time of 2015 did not impose an obligation to approve epidemiological observational studies by the ethics committee; therefore, the opinions of the two ethics committees in the Czech Republic can be used to comply with the ethical principles in both countries), in Russia (Advisory council on ethics St Petersburg state budgetary healthcare institution city hospital No 40, Ethics committee of the federal state budgetary institution state research center, Independent Interdisciplinary Committee for Ethical Review of Clinical Studies [125468, Moscow, Leningradskiy prospect 51]), in Romania (National Commission of Bioethics [Comisia Nationala de Bioetica a Medicamentului si a Dispozitivelor Medicale]), in Hungary (Ethics committees of the Medical Research Council of Hungary [ETT] Egészségügyi Tudományos Tanács Klinikai Farmakológiai Etikai Bizottsága), in Slovenia (Republic of Slovenia Medical Ethics Committee, Institute of Clinical Neurophysiology, University Medical Centre Ljubljana [Komisija Republike Slovenije Za Medicinsko Etiko]), in Croatia (Drug Committee of Clinical Hospital Center Zagreb [Povjerenstvo za lijekove Kliničkog Bolničkog Centra Zagreb], Drug Committee of Clinical Hospital Center Osijek [Povjerenstvo za lijekove Kliničkog Bolničkog Centra Osijek], Drug Committee of Clinical Hospital Center Split [Povjerenstvo za lijekove Kliničkog Bolničkog Centra Split]), and Australia (Belberry Human Research Ethics Committee, Royal Brisbane and Women’s hospital human research ethics committee). All patients gave written informed consent. All authors confirm that they have read the Journal’s position on issues involved in ethical publication and affirm that this work is consistent with those guidelines.
: Not applicable.
: D. P. received payments as a consultant for Boston Scientific and as a speaker on symposia sponsored by Boston Scientific. The institution of D.P., not D.P. personally received funding by Boston Scientific, the Parkinson's Foundation, Dr.-Reinfried-Pohl-Stiftung and the Deutsche Parkinson Vereinigung. D.P. declare that there are no additional disclosures to report. F.G. reports honoraria from AbbVie, BIAL, Merz, and STADA outside the submitted work. W.J. has received honorarium for lectures or advisory boards from AbbVie/Allergan, Bial, Desitin, Ipsen, Merz, Stada, UCB, Zambon. L.T. received payments as a consultant for Boston Scientific, L.T. received honoraria as a speaker on symposia sponsored by UCB, Desitin, Boston Scientific, AbbVie, Novartis, GlaxoSmithKline und DIAPLAN. The institution of L.T., not L.T. personally received funding by Boston Scientific, the German Research Foundation, the German Ministry of Education and Research and the Deutsche Parkinson Vereinigung. A.C. and K.O. are AbbVie employees and may own AbbVie stock.