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Rescue arms Predefined component of a trial designed to allow participants who have not responded or cannot tolerate the assigned treatment to be offered an alternative treatment or intervention (typically, allows participants randomized to placebo to end participation in a blinded component of the trial and receive the investigational product open-label)
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“We only included people who had received prior treatment but still had clinically significant PTSD,” Mithoefer said of the study, which followed the FDA’s strict guidelines for a phase two trial
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