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74Colombel JF, Sandborn WJ, Reinisch W, et al
PubMed Vukojevic, J., Sikiric, P., et al
The approval was based on two key Phase 3 randomized, double-blind, placebo-controlled trials (LIPO-010 and LIPO-011) enrolling a combined 816 patients
The combination itself has not been validated in controlled human trials
So we dont have that same sort of rigour, if you like, on just overall safety. The third safety question is legal, and the answer differs by jurisdiction: United States
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