Strzelczyk, Adam http://orcid.org/0000-0001-6288-9915
Maschio, Marta http://orcid.org/0000-0002-3075-4108
Pensel, Max C. http://orcid.org/0000-0002-2760-2269
Coppola, Antonietta http://orcid.org/0000-0002-6596-3065
Takahashi, Satoru http://orcid.org/0000-0001-6969-8046
Izumoto, Shuichi http://orcid.org/0000-0002-3564-8718
Trinka, Eugen http://orcid.org/0000-0002-5950-2692
Cappucci, Sheri
Sainz-Fuertes, Ricardo http://orcid.org/0000-0003-0980-5748
Villanueva, Vicente http://orcid.org/0000-0003-2080-8042
Funding for this research was provided by:
Eisai Incorporated
Article History
Received: 30 January 2024
Accepted: 5 April 2024
First Online: 28 April 2024
Declarations
:
: Adam Strzelczyk reports personal fees and grants from Angelini Pharma, Bicodex, Desitin Arzneimittel, Eisai, Jazz Pharmaceuticals, Precisis, Takeda, UCB Pharma, and UNEEG medical. Marta Maschio has no conflict of interest. Max C. Pensel has no conflict of interest. Antonietta Coppola has received speaker fees from Eisai and consultancy fees from GW Pharmaceuticals/Jazz Pharmaceuticals, UCB and Bial-Portela & Cª. Satoru Takahashi has no conflict of interest. Shuichi Izumoto has no conflict of interest. Eugen Trinka reports personal fees from EVER Pharma, Marinus, Arvelle, Angelini, Argenx, Medtronic, Bial-Portela & Cª, NewBridge, GL Pharma, GlaxoSmithKline, Boehringer Ingelheim, LivaNova, Eisai, UCB, Biogen, Sanofi, Jazz Pharmaceuticals, and Actavis. His institution received grants from Biogen, UCB Pharma, Eisai, Red Bull, Merck, Bayer, the European Union, FWF Österreichischer Fond zur Wissenschaftsforderung, Bundesministerium für Wissenschaft und Forschung, and Jubiläumsfond der Österreichischen Nationalbank. Sheri Cappucci is an employee of Eisai. Ricardo Sainz-Fuertes is an employee of Eisai. Vicente Villanueva has participated in advisory boards and symposia organised by Angelini, Bial, Biocodex, Eisai Inc, Jazz Pharmaceuticals, Novartis, Takeda, UCB and Xenon.
: Each study in PERMIT was approved by its own independent ethics committee, and all committees were notified about PERMIT. Further approval was not required for participation in PERMIT, as per current legislation. In PROVE, the study protocol was approved by institutional review boards or independent ethics committees at each site. PROVE was conducted under a waiver of consent, due to its retrospective design, which was approved by the ethics committees at each site, and no sites requiring consent were included in the study. All studies included in this article were approved by the appropriate ethics committees and have, therefore, been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.