Funding for this research was provided by:
Takeda Development Center Americas Inc.
Article History
Received: 13 May 2022
Accepted: 29 July 2022
First Online: 24 August 2022
Funding
: This study was funded by Takeda Development Center Americas Inc., a Takeda company, Lexington, MA, USA, which supported the design of the study, the collection, analysis, and interpretation of data, the development of the manuscript, and funded the Rapid Service Fee. The work carried out by Cognigen, a SimulationsPlus company, Buffalo, NY, USA, in support of this study was funded by Takeda Development Center Americas Inc., a Takeda company, Lexington, MA, USA. Aralast and Aralast NP are trademarks of Baxalta Incorporated, a Takeda company.
: Medical writing support was provided by Sarah Morgan, PhD, and editorial support by Jackie Parker, BSc, employees of Excel Medical Affairs (Fairfield, CT), and was funded by Takeda Development Center Americas, Inc., a Takeda company, Lexington, MA, USA.
: 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.
: All authors provided intellectual input into the content of the manuscript, contributed to the writing of this manuscript, approved the final version for submission, and agree to be accountable for all aspects of the work. Zhaoyang Li: conceptualization, methodology, formal analysis, investigation, writing—review and editing; Ryan M. Franke, Denise N. Morris, Leman Yel: methodology, formal analysis, writing—review and editing.
: Zhaoyang Li is an employee of Takeda Development Center Americas, Inc., a Takeda company, and a Takeda shareholder. Ryan M. Franke was an employee of Cognigen, a SimulationsPlus company, Buffalo, NY, at the time the work was conducted, and was funded by Takeda Development Center Americas Inc., a Takeda company, Lexington, MA, USA, to undertake analysis of the data. Ryan M. Franke is now an employee of Pfizer. Denise N. Morris is an employee of Cognigen, a SimulationsPlus company, Buffalo, NY, and was funded by Takeda Development Center Americas Inc., a Takeda company, Lexington, MA, USA, to undertake analysis of the data. Leman Yel is an employee of Takeda Development Center Americas, Inc., a Takeda company, and a Takeda shareholder.
: All three clinical studies were approved by the respective institutional review boards or independent ethics committees at all participating sites, and written informed consent was obtained from each patient prior to enrollment.
: The datasets, including the redacted study protocol, redacted statistical analysis plan, and individual participants data supporting the results reported in this article, will be made available within three months from initial request, to researchers who provide a methodologically sound proposal. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection and requirements for consent and anonymization.