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BBS or POMC, PCSK1, or LEPR Deficiency The safety and effectiveness of IMCIVREE have been established to reduce excess body weight and maintain weight reduction long term in pediatric patients aged 2 years and older with obesity due to: BBS [see Clinical Studies (14.2, 14.4)] POMC, PCSK1, or LEPR deficiency with variants in POMC, PCSK1, or LEPRgenes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) [see Clinical Studies (14.3, 14.4)] Use of IMCIVREE for these indications is supported by evidence from one 66-week trial, which included a 14-week, randomized, double-blind, placebo-controlled period followed by a 52-week open-label period, and included 22 pediatric patients with BBS aged 6 to 17 years (Trial 2)