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The CVOT is not expected to report until well after the initial NDA

doi:10.1111/dom.13358 187

And now that GLP-1 prescriptions have become the hot topic for weight loss, supplement companies are jumping on the bandwagon with products claiming they can do the same thing

Long term data from trials such as STEP and SUSTAIN show that gallbladder events are most common in the first year of treatment when weight loss is most rapid