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Article History

Accepted: 19 January 2025

First Online: 14 February 2025

Declarations

:

: The authors did not receive support from any organization for the submitted work.

: The authors have no competing interests to declare that are relevant to the content of this article.

: Data from Hayley et al. (1993) are used to briefly illustrate the analysis of aggregated events. The original manuscript contains the following statement: “The study protocol and informed-consent form were approved for use by each institution's Institutional Review Board.”

: Data from Hayley et al. (1993) are used to briefly illustrate the analysis of aggregated events. The original manuscript contains the following statement: “The study protocol and informed-consent form were approved for use by each institution's Institutional Review Board.”

: Not applicable. No individual-identifying data are presented.

: Data used to produce Table and Figures and are available through a license to JMP Clinical. Data for Figure   are available through a license to MedDRA.

: Analysis can be performed through a license to JMP Clinical.

: RCZ conceived of and authored the article. RL and GM made substantial contributions to design, review, and analysis. All authors read and approved the final version and are accountable for all aspects of this work.