Tuunainen, Johanna http://orcid.org/0000-0002-2556-510X
Sjöstedt, Noora http://orcid.org/0000-0001-6960-7757
Vahteristo, Mikko http://orcid.org/0000-0001-9388-3997
Ellmén, Juha
Kuoppamäki, Mikko
Rouru, Juha http://orcid.org/0000-0003-1520-2230
Yliperttula, Marjo http://orcid.org/0000-0003-0726-5733
Article History
Accepted: 9 October 2022
First Online: 30 October 2022
Declarations
:
: The authors thank the participants, investigators, trial-site staff, and Orion Pharma employees involved in the studies. Hanna Wartiovaara is acknowledged for the supervision of the bioanalytical work. Mikko Koskinen is acknowledged for reviewing the manuscript.
: Participated in clinical study design and study conduct: JT, MV, JE, JK and JR. Performed data analysis and modelling: JT, NS, MV and MY. All authors contributed to the writing of the manuscript and approved the final version for publication.
: The clinical studies were sponsored by Orion Corporation, Orion Pharma. No funding was received for the preparation of this article.
: The study data are available from the corresponding author upon reasonable request.
: Upon reasonable request.
: Johanna Tuunainen, Mikko Vahteristo, Juha Ellmén, Mikko Kuoppamäki, and Juha Rouru were employees of Orion Corporation, Orion Pharma, Finland, at the time of study conduct. Mikko Vahteristo and Mikko Kuoppamäki own stock in Orion Corporation. Noora Sjöstedt and Marjo Yliperttula declare that they have no conflict of interest.
: All studies were conducted in accordance with the International Council for Harmonization Good Clinical Practice, the principles of the Declaration of Helsinki, and all applicable national regulations. The presented study was approved by the ethics committee of the Hospital District of Helsinki and Uusimaa (250/13/03/00/2008). The studies used for pharmacokinetic model building were approved by the Manchester independent research ethics committee (ME1004/3097001) and the ethics committee of the Hospital District of Helsinki and Uusimaa.
: For all clinical studies described in the article, informed consent was obtained from the participants.
: Not applicable.