Data Availability
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. Data requests will be reviewed by Vivli and Takeda for completeness and other parameters (relating to scope, system-compatibility, and meeting sponsor policies) and will then be reviewed by an independent review panel. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection and requirements for consent and anonymization. Data requests should follow the process described in the Data Sharing section on 