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Work closely with the FDA via meetings such as the pre-investigational new drug (IND) phase meetings, Type C meetings, and pre-NDA meetings to gain the FDAs input regarding the scope of its proposed studies

Participants randomized to the placebo group received sham subcutaneous injections

Unresolved inflammation results in formation of vulnerable plaques characterized by enhanced macrophage apoptosis and defective efferocytosis of apoptotic cells resulting in necrotic cell death leading to increased smooth muscle cell death, decreased extracellular matrix production, and collagen degradation by macrophage proteases

Many first-time researchers assume "fridge shelf life" means one answer, but the lyophilized and reconstituted forms have dramatically different stability timelines

No randomization was used to allocate animals to experimental groups, and investigators were not blinded to the group allocation during experiments or outcome assessments