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And, while new manufacturing capacity is planned, the timelines to bring regulated facilities online are significant
Serious adverse effects requiring immediate medical attention include severe abdominal pain radiating to the back (potential pancreatitis), right upper quadrant pain, fever, or jaundice (potential gallbladder disease), persistent vomiting preventing oral intake or reduced urination (dehydration/kidney injury risk), visual changes (diabetic retinopathy concerns), or signs of allergic reaction such as rash, difficulty breathing, or facial swelling
The positive cells were quantified using ImageJ software
The Panel conceptualized potential AEs in terms of severity, duration and reversibility
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