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Safety data comes exclusively from cell culture and animal studies

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Pregnancy: Teratogenic Effects

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The prolonged presence of these cells on at a relatively higher level suggested a still ongoing remyelination process that requires the continuous generation of new OLs and the synthesis of myelin-related proteins for the forming of new compact myelin, although the myelin score by LFB-PAS staining has already returned to a level indistinguishable from the normal control by 3 weeks after CPZ withdrawal

Quigley R