title: The regulatory perspective.
authors.affiliation: SDG, LLC, Cambridge, MA, USA.
authors.forename: L S
authors.initials: LS
authors.lastname: Simon
mesh_terms: D017322:Clinical Trials, Phase II as Topic / Q000379:methods* / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D010523:Peripheral Nervous System Diseases / Q000628:therapy*; D014481:United States