Points to consider: efficacy and safety evaluations in the clinical development of ultra-orphan drugs.

Orphanet J Rare Dis · 2017 · PMC5569502 · PMID 28835285

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a positive trendno p-value reported

A significant difference was observed in forced vital capacity after 26 weeks, but it was not observed in the 6-min walk distance even though a positive trend was observed.

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