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(Vienna, Austria).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"D.R.C. reports consulting for Amgen Inc., Annexon Biosciences, Boehringer Ingelheim, Grifols S.A., Johnson & Johnson, Neura Bio, Novartis, Octapharma AG, Pfizer Inc., Roche, Seattle Genetics Inc., Valenzabio. D.R.C. is on the Data Safety Monitoring Board for the following: PledPharma, Hansa Medical, and Mitsubishi Tanabe Pharma Corporation. D.R.C. is on the Scientific Advisory Board for Sinomab, Algotherapeutics, Nervosave. D.R.C. received royalties for technology licensing from Worldwide Clinical Trials, Inc., CMIC, MedImmune Ltd., RWS Life Sciences, Levicept, AstraZeneca Pharmaceuticals, LP, Genentech, Inc., Chiesi Farmaceutici S.p.A., Beijing 3E-Regenacy Pharmaceuticals Co., Passage Bio, and Disarm Therapeutics, outside the submitted work. P.A.v.D. reports grants from Sanquin Blood Supply Prinses Beatrix Spierfonds, and Takeda during the conduct of the study; and consulting fees from Annexion, Argenx, Octapharma, and Hansa, all outside the submitted work. All grants and consulting fees are transferred to the Erasmus MC Research fund. H.P.H. reports consulting for\u00a0CSL Behring, Sanofi Genzyme, and UCB. H.P.H. received payments or honoraria from CSL Behring and Octapharma. I.S.J.M. reports grants from Talecris Talents program, GBS\/CIDP Foundation International and FP7 EU program, outside the submitted work. Furthermore, a research foundation at the University of Maastricht received honoraria on behalf of him for participation in steering committees of the Talecris Immune Globulin Intravenous For Chronic Inflammatory Demyelinating Polyneuropathy Study, Commonwealth Serum Laboratories, Behring, Octapharma, LFB, Novartis, Union Chimique Belge, Johnson & Johnson, Argenx, outside the submitted work. And Octapharma during the conduct of the study. H.D.K. is on Steering Committees for Octapharma and Sanofi Genzyme. H.D.K. reports travel support and consulting fees from Octapharma in relation to a study design advisory board. H.D.K. reports consulting for UCB, Terumo, Akcea, Alnylam, CSL Behring, Merz, Pfizer, Roche and Dyne. H.D.K. is on Data Safety Monitoring Boards or Advisory Boards for UCB, Syneos and Octapharma. H.D.K. received a grant from Takeda for investigator-initiated research. D.H. and E.C. are employees of Octapharma PPG, Vienna, Austria.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The ProCID study protocol and key results are available at . To safeguard patient privacy, individual patient data will not be shared.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"The ethics committees of all participating centres approved the study protocol in accordance with the 1964 Helsinki Declaration. The study was approved in Canada by the NEUPSY Research Ethics Board of the McGill University Health Care centers (#2018-4058), in Bulgaria by the Ministry of Health Ethics Committee for Multicenter Trials (#KH-63\/21.07.17), in Hungary by the Medical Research Council Ethics Committee for Clinical Pharmacology (ECCP; # ETT File No. 24931-0\/2017-EKL), in Ukraine by the ethics board of the Municipal Institution \u201cZaporizhzhia Regional Clinical Hospital\u201d (05.05.2017: #91), by the Ethics Committee at Ivano-Frankivsk Regional Clinical Hospital (Committee Meeting #28, 24.04.2017), by the Ethics Committee at Volyn Regional Clinical Hospital (Committee Meeting #108 28.04.2017), by the Ethics Committee of Kyiv City Clinical Hospital No. 9 (Committee Meeting #145\/02), by the Ethics Committee at Municipal Institution \u201cO.I. Yushchenko Vinnytsia Regional Psychoneurological Hospital\u201d (Agreed Opinion 04.05.2017: #09.17), in Romania by the Academy of Medical Sciences National Bioethics Committee for Medicine and Medical Devices (No. 15S\/1-4\/13.04.2017, 685A-3.05.2017, 875A-10.07.2017), in Czech Republic by the Ethics Committee, University Hospital Hradec Kralove (CEC Reference Number: 201705 D06M, LEC: 532\/21.04.2017), by the Ethics Committee of the Institute of Clinical and Experimental Medicine and Thomayer Hospital (CEC Reference Number: 201705 D06M, LEC: 666\/17 + 905\/17), by the Ethics Committee Oblastni nemocnice Nachod a.s. (CEC Reference Number: 201705 D06M, LEC: S0065\/2017), in Poland by the Bioethics Committee at the Warmia and Mazury Medical Chambers in Olszyn (Resolution No 12\/2017\/VI), in Germany by the Ethics Committee of the University Medical Center G\u00f6ttingen (#14\/2\/17; 28.04.2017), in Russia by the Central Ethics Committee of the Ministry of Health of the Russian Federation, Council of Ethics (Vn. No 51693) and the Local Ethics committees of the Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko, City Multi-Field Hospital No. 2 Budgetary Public Health Facility of Saint-Petersburg, Republican Clinical Neurological Centre Kazan, Independent Ethics Committee at FSBI \"Saint Petersburg V.M. Bekhterev Psychoneurological Research Institute\", Ethics Committee at Federal State-Financed Research Institution Neurology Research Center.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All patients gave written informed consent prior to any study-related procedures.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"D.R.C., P.A.v.D. and H.D.K. contributed substantially to the conception and design of the study. D.R.C. drafted the manuscript, which was revised critically by all other authors. All authors read and approved the final manuscript before submission.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}