Table 1.

Summary of Protocol Schedule of Events

Schedule and Category/Tests	Endpoint
At Entry
Informed consent	signed by subject for study enrollment
Annually
History and physical exam	evaluation of concurrent or new co-morbidities, concomitant medications, or vital sign or physical exam abnormalities
Blood tests	FIX activity, FIX inhibitor, aPTT, CBC, chemistry, α-fetoprotein
Urinalysis	any significant findings
Adverse events	any oncologic, hematologic neurologic or auto-immune adverse events
At Entry and Every 3 Years
Liver ultrasound	any clinically significant findings

FIX, factor IX; aPTT, activated partial thromboplastin time; CBC, complete blood count with differential.