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AAV adeno-associated virus AAV5 adeno-associated virus serotype 5 AAVRh74var adeno-associated virus serotype Rh74var ABR annualized bleeding rate AE adverse event ALT alanine aminotransferase AST aspartate aminotransferase BEQVEZ fidanacogene elaparvovec BLA biologics license application BMI body mass index CAG chicken beta ‐ actin CDRH Center for Devices and Radiological Health CI confidence interval CMC chemistry, manufacturing, and controls CSA chromogenic assay EEP efficacy evaluation period FIX clotting factor IX FIX:C circulating levels of FIX LTFU long-term follow-up nAb neutralizing antibody NI non-inferiority OSA one-stage assay PI package insert PMC postmarketing commitment PMR售后需求Pro患者报告的结果REMS风险评估和缓解策略RP常规预防SAE SAE严重不良事件SD标准偏差teae teae exter-everermergerement Extress Eversem forverse Everse uln USPI USPI USPI USPI美国处方信息VG矢量基因组的上限
临床审查备忘录-Beqvez
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