1. History of FIX inhibitors

2. Positive FIX inhibitor test at screening

3. Select screening laboratory values \> 2 times upper normal limit:

4. Positive human immunodeficiency virus (HIV) at screening, not controlled with anti-viral therapy

5. Active infection with Hepatitis B or C virus at screening

6. History of Hepatitis B or C exposure, currently controlled by antiviral therapy

Dose Confirmation Trial of AAV5-hFIXco-Padua