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Per the FDA, compounded drugs that contain DSIP may pose a risk for immunogenicity,26 a state in which the body perceives a substance as a threat and so mounts a potentially life-threatening immune response against it
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Nevertheless, although ANVISA acknowledged the identification of several irregularities in the compounding of these drugs and affirmed that inspections regarding the irregular advertising and supply of medicines have been carried out on a continuous basis, the number of medical clinics engaging in unlawful practices demonstrates that such measures have not been sufficient
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A stopping rule was applied where treatment was discontinued for patients who did not achieve 5% weight loss
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