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Additionally, variation in study populations, trial design and baseline cardiovascular risk may have influenced the observed outcomes

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doi: 10.1159/000264392 120 RitterRC

The gene therapy is specifically approved for those patients who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or repeated, serious spontaneous bleeding episodes and do not have neutralizing antibodies to the adeno-associated virus serotype Rh74var (AAVRh74var) capsid