Hutchison, R. Matthew
Evans, Karleyton C.
Fox, Tara
Yang, Minhua
Barakos, Jerome
Bedell, Barry J.
Cedarbaum, Jesse M.
Brys, Miroslaw
Siderowf, Andrew
Lang, Anthony E.
Funding for this research was provided by:
Biogen
Article History
Received: 26 March 2021
Accepted: 25 October 2021
First Online: 23 November 2021
Declarations
:
: The study was done in accordance with applicable International Conference on Harmonisation and Good Clinical Practice Guidelines. Ethics approval was granted by each participating centre’s local or national independent ethics committee.Central IRBs. Advarra IRB (Ethics committee reference number [ECRN] = CR0028876):Booth Gardner Parkinson’s Care Center at Evergreen Health, Inland Northwest Research, Quest Research Institute, Synexus Clinical Research US, Inc. – Orlando, USF Health Byrd Institute, Parkinson’s Disease and Movement Disorders Center, Dignity Health, University of Pittsburgh Medical Center Health System, Ochsner Health System, University of California San Francisco Medical Center, UC San Diego Movement Disorder Center. Ethikkommission der Medizinischen Universität Innsbruck (ECRN = 1264/2017): Medizinische Universität Innsbruck. Comite de Protection des Personnes (CPP) Ile-de-France VIII (ECRN = 18 04 20): Groupe Hospitalier Pitie-Salpetriere, CHU Nantes - Hopital Nord Laënnec, Hopital Roger Salengro - CHU Lille, Hopital Purpan, Hôpital Henri Mondor, CHU CAEN - Hôpital de la Côte de Nacre. Medizinische Fakultät der Christian-Albrechts-Universität zu Kiel – Ethikkommission (ECRN = A114/18): Universitaetsklinikum Schleswig-Holstein- Campus Kiel, Klinikum rechts der Isar der TU Muenchen, Paracelsus-Elena-Klinik Kassel, Universitaetsklinikum Ulm, Universitaetsklinikum Wuerzburg, Universitaetsklinikum Aachen AOeR, Katholisches Klinikum Bochum gGmbH. Comitato Etico Catania (ECRN = 11/2018/PO): Azienda Ospedaliera Universitaria “Policlinico - Vittorio Emanuele” (Presidio Gaspare Rodolico). Comite Etico de Investigacion Clinica (ECRN = not applicable): Hospital General de Catalunya, Complejo Hospitalario Ruber Juan Bravo, Clinica Universidad de Navarra, Hospital Clinic de Barcelona, Hospital Universitario Virgen del Rocio, Hospital Universitario Ramon y Cajal, Hospital de Cruces, Hospital de la Santa Creu i Sant Pau, Centro Integral en Neurociencias A.C. HM CINAC, Hospital General Universitario Gregorio Marañon. Central Bristol Research Ethics Committee South West (ECRN = 18/SW/0023): Royal Hallamshire Hospital, The National Hospital for Neurology & Neurosurgery, John Radcliffe Hospital, Campus for Ageing and Vitality, Addenbrooke’s Hospital, Salford Royal.Local IRBs. University of Pennsylvania IRB (ECRN = 828941): University of Pennsylvania. University of Cincinnati IRB (ECRN = CR01_2017_7022): University of Cincinnati. Cleveland Clinic Institutional Review Board (ECRN = 17-1634): Cleveland Clinic. Weill Cornell Medicine vIRB (ECRN = 1706018308): Weill Cornell Medical College. Medical University of South Carolina IRB (ECRN = Pro00075276): Medical University of South Carolina. Colorado Multiple Institutional Review (ECRN = 17-1532): University of Colorado Denver | Anschutz Medical Campus and its affiliates. Columbia University IRB (ECRN = IRB-AAAS1203): Columbia University. WCG IRB (ECRN = 120190379): Boston University Medical Center. Northwestern University Institutional Review Board (ECRN = STU00206260-CR0001): Northwestern University. WCG IRB (ECRN = 20180655): University of Alabama at Birmingham. Cedars-Sinai Medical Center IRB (ECRN = Pro00050848): Cedars Sinai. Partners Human Research Committee (ECRN = 2017P002612): Mass General Brigham. Stanford University Administration Panel on Human Subjects in Medical Research (ECRN = 43684): Stanford University. Medical College of Wisconsin IRB (ECRN = PRO00030566): Medical College of Wisconsin. University of Kansas Medical Center IRB – Human Subjects Committee (ECRN = STUDY00141836): University of Kansas Medical Center. Duke University Health System IRB Office (ECRN = Pro00089579): Duke University Medical Center. Rush University Medical Center (ECRN = 16110708-IRB01): Rush University Medical Center. BRANY IRB (ECRN = 18-02-40Q-02): NYU Langone Medical Center. Wake Forest University Health Sciences IRB (ECRN = IRB00048686): Wake Forest Baptist Health Sciences. University at Buffalo IRB (ECRN = STUDY00002128): University at Buffalo. Mayo Clinic IRB – Rochester (ECRN = 18-002639): Mayo Clinic. Vanderbilt University IRB Human Research Protections Program (ECRN = 180183): Vanderbilt University. Houston Methodist Research Institute IRB (ECRN = Pro00019195): Houston Methodist Neurological Institute. HCA-Health One IRB (ECRN = 1201685-14): Rocky Mountain Movement Disorders. MUHC Research Ethics Board NEUPSY Panel (ECRN = 2018-4243): Montreal Neurological Institute - Hospital MUHC. University Health Network Research Ethics Board (ECRN = 18-5172): University Health Network. Comitato Etico Campania Sud (ECRN = 7_ rpsc /2018): Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D’Aragona. Comitato Etico Regione Toscana - Area Vasta Nord Ovest (ECRN = 12839_BONUCCELLI): Azienda Ospedaliero Universitaria Pisana. Comitato Etico dell’IRCCS Neuromed-Istituto Neurologico Mediterraneo (ECRN = 01/18): I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo. Comitato Etico Indipendente Di Area Vasta Emilia Centro (ECRN = 428/2018/FARM/AUSLBO): Ospedale Bellaria. Comitato Etico IRCCS San Raffaele Pisana (ECRN = 02/18): IRCCS San Raffaele Pisana. Comitato Etico Universita’ Vanvitelli Di Napoli, Aou Vanvitelli – Aorn (ECRN = 98/2018): Azienda Ospedaliera Universitaria- Università degli Studi della Campania “Luigi Vanvitelli”. Comitato Etico IRCCS Ospedale S. Raffaele di Milano (ECRN = 81/2018): Ospedale San Raffaele. Comitato Etico IRCCS Ospedale S. Raffaele - di Milano (ECRN = 70/2018): Ospedale San Raffaele. Comitato Etico delle Aziende Saniitarie dell’Umbria (ECRN = 3165/18): Azienda Ospedaliera Santa Maria di Terni. Comitato Etico Milano Area 2 (ECRN = 191_2018): Fondazione IRCCS CA’ Granda Ospedale Maggiore Policlinico. Helsinki Committee, Tel Aviv Sourasky Medical Center (ECRN = 0016-18-TLV): Tel Aviv Sourasky Medical Center. Helsinki Committee, Rambam Health Care Campus (ECRN = 0015-18-RMB): Rambam Health Care Center.Written informed consent was obtained from all patients (or guardians of patients) participating in the study.
: Not applicable.
: R. M. Hutchison, K. C. Evans, <i>T. Fox</i>, and M. Yang are and/or have been employees of and own stock or have stock options, or both, in Biogen. J. M. Cedarbaum and M. Brys were employees of Biogen while completing this work and may own Biogen stock. B. J. Bedell has received compensation and shares from Biospective. The other authors have no relevant disclosures to declare.