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Across all six studies, the safety findings were consistent: no serious adverse events, no immunogenic responses, no changes in IGF-1, no glucose or insulin disruption

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In these cases, individuals might actually experience weight loss rather than gain

Response: We have noted in past rules that we use the functional impairment level case-mix adjustment, developed as part of the PDGM case-mix, to provide the necessary payment adjustments to ensure that functional care needs are met based on actual patient characteristics