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4a and 6a) 37,38
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Demonstrated clinically significant allergic reactions (for example, food, drug, or atopic reactions, asthmatic episodes) that required intervention, (for example, emergency room visit, epinephrine administration) and which, in the opinion of the investigator, would interfere with the participants ability to participate in the trial
We track HbA1c, triglycerides, inflammatory markers, and blood pressure alongside body composition changes using DEXA or bioelectrical impedance analysis (BIA)
The short-term framing follows directly from both facts