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In most cases, company responses to FDA warning letters are not made public
The STEP 1 trial demonstrated 14.9% body weight reduction, and the SELECT trial showed 20% MACE reduction
The medications carry risks including gastrointestinal side effects that may limit tolerability, potential pancreatitis, and substantial cost (often $900-1,400 monthly without insurance coverage)
USA 109 , 82368240 (2012)
However, slower digestion can trap gas and create a sensation of fullness or distension, especially after eating solid foods or larger portions
While we are not finalizing adoption of the Information Transfer PRO-PM in this final rule, we will take these comments into consideration if we propose the measure in the future
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