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Description

The mental health claims are extrapolations from animal data and mechanistic speculation

The FDA nod is based on the Phase III GENESIS trial, which compared Aphexda plus filgrastim against placebo plus filgrastim

The compound reduces plasma creatine kinase levels (a marker of muscle damage) and decreases malondialdehyde concentration (indicating reduced lipid peroxidation) in exercised muscle tissue

Furthermore, serum PAI-1 antigen and tPA antigen levels were assessed by evaluation of blood samples drawn in CTAD vacutainers using ELISA assay kits obtained from Biopool, Umeea, Sweden