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Splenic accumulation may lead to marginal zone expansion or increased oxidative stress, although these effects are generally mild at pharmacologically relevant doses
Phase 2 dose-ranging trials followed in 20042006, and the pivotal Phase 3 trials (studies LIPO-010-05 and LIPO-010-06) ran from 2006 to 2009 , forming the efficacy basis for the November 2010 FDA approval
