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The co-primary endpoints of the study at 72 weeks were the percentage change in weight from baseline and a body weight reduction of 5% or more (82)

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The FDA describes a facility where drug products intended to be sterile were produced in environments that may not have provided adequate contamination protection, where products that failed sterility and potency testing were released and distributed, where out-of-specification investigation procedures were not followed in a single documented case out of 23 reviewed, and where patients were not notified when the drugs they received were found to be subpotent or failed sterility testing