Program of analysis set
PFO
ADVERSE EVENTS
The complete analysis plan consists of three sets: Full Analysis Set (FAS), Per-Protocol Analysis Set (PPS), and Safety Set (SS). The FAS and SS will include all randomly assigned participants, but those with serious protocol violations, active withdrawal, serious adverse events, or extremely poor compliance will be excluded from the PPS. For the FAS, we intend to follow the modified intention-to-treat (mITT) analysis principles, which exclude participants without a PFO diagnosis confirmed by intracardiac echocardiography during the surgical procedure.