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Suicidal and self-injurious reports were queried by combining the MedDRA 26.0 preferred terms (PTs) of the standard MedDRA query (SMQ) for “suicide/self-injury.” The precise terms used were “assisted suicide,” “Columbia suicide severity rating scale abnormal,” “completed suicide,” “depression suicidal,” “intentional overdose,” “intentional self-injury,” “poisoning deliberate,” “self-injurious ideation,” “suicidal behavior,” “suicidal ideation,” “suicide attempt,” “suicide threat,” “suspected suicide,” “suspected suicide attempt.” Utilization of globally accepted and clinically validated mesh terms enabled us to effectively address the reports pertaining to the objectives of this study