AusPAR Attachment 2. Extract from the Clinical Evaluation ...
Plasma derived FIX (MonoFIX-VF, CSL Ltd) which is manufactured from blood donated to the Australian Red Cross Blood Service. ... Study design, objectives, locations and dates. This study was an open-label, Phase III trial, with 4 arms. The design is summarised in Figure 1. ... In this study, plasma samples were tested for FIX inhibitors at a ... ................
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