Idebenone does not inhibit disability progression in primary progressive MS.

The mean change of CombiWISE AUC between baseline and double-blind phase in the idebenone group was −0.13 (SD=2.17) and it did not reach statistical significance (p=0.77); the mean change of CombiWISE AUC within the placebo group was −1.04 (SD=2.87), reaching p-value of 0.03 ( Fig 2C ); providing evidence for measurable placebo effect.

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If CSF GDF15 is true biomarker of mitochondrial dysfunction of CNS cells, which our data don’t unequivocally support, then idebenone not only did not inhibit mitochondrial dysfunction in PPMS, but may have even slightly exacerbate it based on increase in GDF15 (and albumin quotient) that reached borderline significance in the idebenone group.

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Nevertheless, we are extremely cautious about making conclusions from such subtle changes of borderline significance, as these likely represent Type 1 errors.

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