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Central Nervous System & Ophthalmology Section, Safety & Efficacy of Medicines, European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK. florence.butlen@ema. europa.eu
The publication of the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) in 2013 raises important questions for clinical trials and associated regulatory decisions on new drugs for psychiatric disorders.
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