2024-516022-63-00
Registration, authorisation of a trial application, trial start, result disclosure and marketing authorisation are different facts. The dossier claims neither clinical efficacy nor safety, deployment or causality.
CTIS record ≠ efficacy ≠ marketing authorisationTerms count only in allowlisted public CTIS fields. Sponsor, medical condition, phase or a generic software reference alone is not AI evidence.
“Identification of the best biomarkers predicting an unfavorable disease course will be carried out using conventional regression and machine learning methods. Discrimination and calibration performances will be systematically evaluated and compared for each of the models constructed.”
A status in one country is not transferred to another. Decision dates and status histories remain separate source facts.
Decisions06 November 2024 · Authorized
Country statusFrance · Authorised
Decisions17 September 2025 · Authorized
Country statusFrance · Authorised
The chronicle sorts published CTIS events. i6eal observation times follow on a separate clock.
No result disclosure is published in this projection. This means neither that results do not exist nor that a deadline has been missed.
The public CTIS record remains authoritative. The i6eal files are a deterministic, bounded projection.
i6eal (2026): EU AI Studies Monitor, CTIS trial 2024-516022-63-00, data state 23 July 2026. https://i6eal.de/en/tools/ki-studienmonitor/studie/2024-516022-63-00/These tools complement the current result.