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Both are likely to require either significant real world observation in off-label use, or some form of RCT with careful observation
With a 503B facility, quality testing is required, documented, and subject to federal oversight
Thats where Breakthrough T1D comes in
So, make sure to follow the instructions that come with your SemaSize pen and talk to your doctor for advice that's just right for you
Would you be willing to try something like that
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