The authors would like to thank all the participants of these studies.
Both studies were funded by Astellas Pharma Europe B. V. and journal’s Rapid Service Fee was funded by Astellas Pharma Inc.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Dr. Dirk Cerneus, Dr. Ingrid Michon, MSc. Sanne Rijnders, MSc. Desiree van der Heide; MSc. John Meijer were employees of Astellas Pharma Europe B. V. at the time of the conduct of the work. Dr. Yuichiro Sato, MSc. Masaomi Takizawa and Dr. Matthias Stoelzel are employees of Astellas Pharma Inc. The authors have indicated that they have no other conflicts of interest with regard to the contents of this article.
Compliance with Ethics Guidelines
Both studies were conducted in accordance with ethical principles that have their origin in the Helsinki Declaration of 1964 and its later amendments, Good Clinical Practice, International Conference on Harmonization guidelines, and applicable laws and regulations. Protocols and informed consent forms of both studies were approved by the Independent Ethics Committee (Medisch Ethische ToetsingsCommissie). Study 1 was conducted at a clinical center of PRA International (Zuidlaren, the Netherlands) from July 2008 to May 2009 and study 2 at a clinical center of PRA International (Groningen, the Netherlands) from May 2009 to May 2010. All subjects provided written informed consent before screening.
The datasets generated or analyzed during the both studies are available at https://www.clinicalstudydatarequest.com. For the Astellas criteria on data sharing, see https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Astellas.aspx.