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In its CRL announcement, ARS said it had aligned with the FDA on physician labeling and post-market requirements, which included a repeat-dose study of neffy under allergen-induced allergic rhinitis conditions
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Specifically, no differences were detected between cases and controls groups in terms of age (p-value = 0.27), sex (p-value = 1) and median glycated hemoglobin (p-value = 0.08)
