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LEADER was a post-approval trial mandated by the FDA as part of the changed guidelines (212), following the CV safety issue associated with the peroxisome proliferator-activated receptor (PPAR) class of agents

Intramuscular injection near an injury site (a common self-administration approach) adds a theoretical local concentration benefit that has some support in animal wound models but has not been tested head-to-head against subcutaneous delivery in a controlled trial

Diabetes, Obesity & Metabolism, 20 ,

Under the Act, the abovementioned peptides are classified as a prescribed restricted substance