Aceneuramic Acid Extended Release Administration Maintains Upper Limb Muscle Strength in a 48-week Study of Subjects with GNE Myopathy: Results from a Phase 2, Randomized, Controlled Study.

J Neuromuscul Dis · 2016 · PMC5271423 · PMID 27854209

Europe PMC DOI

hedged sentences

0.0860

closest p · 1.7× alpha

0.0970

boldest claim

The sentences

showed a trendp = 0.086so close (0.05 < p ≤ 0.1)

In the primary pre-specified ANCOVA analysis, the combined 6 g/day (6/6+0/6 g/day) versus the combined 3 g/day (3/3+0/3 g/day) comparison showed a trend toward a difference for the GNEM-FAS total score ( p = 0.086), the mobility domain score ( p = 0.087), and the upper extremity domain score ( p = 0.096).

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a trend toward significancep = 0.097so close (0.05 < p ≤ 0.1)

At Week 24, serum CK levels were decreased from baseline by approximately 10% in the 6 g/day group (–26.9 U/L, SD 113.1) relative to an increase of more than 10% in the placebo group (+38.6 U/L, SD 107.8) with the difference showing a trend toward significance ( p = 0.097).

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did not reach statistical significanceno p-value reported

In the pre-specified subgroup analysis for subjects who walked ≥200 m at Screening, the 6 g/day and 3 g/day groups showed larger changes at Week 24 compared to the overall group of +2.2 and +2.7 kg, respectively, but did not reach statistical significance ( Table 2 ).

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