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We used FineGray sub-distribution hazard model analyses adjusted for sex and age to assess the association of sociodemographic variables, comorbidities and co-medications (defined in ESM Table 2) with the risk of treatment discontinuation

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While this type of testing is not the same as FDA approval, it can provide an additional layer of quality assurance beyond internal processes

The hypoglycemia risk discussed below is real preclinical and Increlex (mecasermin) human data both demonstrate it

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