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The ADRs of interest include suicidal ideation, self-injurious ideation, suicidal behaviors, and self-injurious behaviors (see Additional file 1: Table S1 for a detailed list), which are homogenously attributed to a high-level group term (HLGT) named suicidal and self-injurious behavior by MedDRA (version 26.0)

9) Lincoff, A

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