Abstract:A231 based on the same clinical studies and corresponded to improvement in respiratory symptoms (as measured by the CFQ-R). In one case, the improvement in respiratory symptoms was considered as primary endpoint (aztreonam lysine-one study). ConClusions: There are few PRO labeling claims in products approved for CF in Europe and the United States. Discrepancies exist in the CF guidance issued by the FDA and the EMA, where EMA is more favorable to PRO endpoints.
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