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SAEs have to be reported by the center as defined in the protocol section on SAEs, i.e.:
• Initial report: within 24 hours of becoming aware of the event
• Follow-up report: within 2 weeks after initial report. In case the SAE is reported as ongoing after 14 days, the follow-up report has to be sent again with the final outcome.
The SAE Form can be found like all other forms on the patient schedule. It consists of an initial report (2 pages) and follow-up report (1 page).