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The Writing Group on behalf of the Edaravone (MCI-186) ALS 19 Study Group Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial

Pregnant or breastfeeding women should not use AOD-9604 due to lack of safety data in these populations

10.1016/j.carbpol.2019.05.067 16 BertleinS.BrownG.LimK

However, as discussed in the next section, key historical events affecting APAP use in the pediatric population have been documented that can be useful in estimating APAP use through time