Wernicke, Joe F.
Verstak, Tatsiana
Zhang, Tianming
Spalding, William
Lee, Laurie
Cheng, Yue
Ademi, Alicia
Funding for this research was provided by:
Takeda
Article History
Accepted: 8 August 2023
First Online: 5 September 2023
Declarations
:
: This study was sponsored by Takeda.
: JFW, TV, TZ, and WS are employees of Takeda and hold stock/stock options in Takeda. LL was a fellow of Takeda at the time of the analyses. YC and AA were interns of Takeda at the time of the analyses.
: 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 3 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. Data are available upon request via application at ExternalRef removed.
: Not applicable because data are from a global safety database that contains spontaneous post-marketing reports from patients and healthcare professionals.
: Not applicable.
: Not applicable.
: Not applicable.
: JFW and TV were responsible for the study design, implementation, and data extraction. TZ and YC conducted the statistical analysis. All authors were involved in interpreting the results, contributed to the preparation of this manuscript, and read and revised each draft. All authors have read and approved the final manuscript for submission and agree to be accountable for the work.