A second dose of rIX-FP was administered at least 24 h after the first injection, if needed, to achieve hemostatsis, as determined by the judgment of the patient and/ or provider.

NC, not calculated.

Probability of success is derived from a repeated measures model (expressed as percentages) and is defined as the probability of achieving hemostasis with 1 or 2 infusions.

Hemostatic response was evaluated by the physician. Definitions of hemostatic response: excellent, pain relief and/or unequivocal improvement in objective signs of bleeding at ∼24 h after the first infusion and no additional infusions required in order to achieve hemostasis; good, definite pain relief and/or improvement in signs of bleeding at ∼24 h after the first infusion but required a second infusion in order to achieve hemostasis; moderate, probable or slight beneficial effect at ∼24 h after the first infusion and required >2 infusions to achieve hemostasis; poor/no response, no improvement or worsened at ∼24 h after the first infusion and additional hemostatic intervention required with other FIX product or plasma to achieve hemostasis.