Safety Oversight
An Independent Safety Board reviews predefined adverse events of special interest in a blinded manner. An Independent Data Monitoring Committee monitors unblinded efficacy and safety data and can recommend continuing, modifying, or termina…
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An Independent Safety Board reviews predefined adverse events of special interest in a blinded manner. An Independent Data Monitoring Committee monitors unblinded efficacy and safety data and can recommend continuing, modifying, or terminating the trial. Potential adverse events of special interest include narcolepsy-like symptoms, complex sleep behaviours, hallucinations or sleep paralysis, suicidality, and drug-abuse-potential events.