Feldman, Steven R.
Kay, Richard
Reznichenko, Nataliya
Sobierska, Joanna
Dias, Roshan
Otto, Hendrik
Haliduola, Halimu N.
Sattar, Abid
Ruffieux, Ruth
Stroissnig, Heimo
Berti, Fausto
Funding for this research was provided by:
Alvotech
Article History
Accepted: 10 April 2023
First Online: 19 May 2023
Declarations
:
: The study was sponsored by Alvotech Swiss AG. Employees of the sponsor had a role in study design, data analysis, and manuscript preparation. Employees of the funder had no role in data collection.
: SRF has received research grants from AbbVie, Janssen, Lilly, and Novartis and speaker honoraria from Alvotech, AbbVie, Amgen, Lilly, Novartis, and Janssen. RK’s company has received consultancy fees in relation to this study and in other studies conducted by Alvotech, but no consultancy fees have been received in relation to the writing of this manuscript. NR declares that she has no conflicts of interest that might be relevant to this work. RD, HO, HNH, AS, RR, HS, and FB are employees at Alvotech. JS was an employee of Alvotech at the time of the study.
: The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.
: Not applicable.
: The study was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, and the appropriate regulatory requirements in the countries in which the study was conducted. The protocol, its amendments, and informed consent documentation were reviewed and approved by the institutional review board(s) or independent ethics committee(s) at each study site.
: All participants signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form before any study-specific procedures were performed.
: Not applicable.
: SRF, RK, HS, FB, HNH, AS, JS, and HO were involved in the conception and design of the study. NR, RD, and RR were involved in the provision of study materials and participants and acquisition of the data. SRF, RK, HS, FB, HNH, AS, JS, and HO did the analysis and/or the interpretation of the data. All authors revised and approved the final manuscript.