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The latter criterion was formulated because the aim of CARAT was to reduce the primary outcome HbA1c with the intervention by 0.5%% points considering the current recommendations (HbA1c = 6.5%%) at study onset [ 7].
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Finally, a minimal model that is consistent with the second derivative criterion is formulated.
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The required M&V accuracy in terms of the 90/10 criterion is formulated as the constraints of this optimisation problem.
A simple statistically-based theoretical model, combined with a failure criterion, is formulated to describe the observed complex mechanical response.
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