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At the same time, the study is observational, not randomized, and its effect sizes are strong enough that they demand careful interpretation rather than immediate clinical enthusiasm

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The body adapts to the new dose over approximately two weeks, at which point the effects stabilize until the next escalation

The questions a serious diligence pass has to answer are whether the estate covers the formulation you intend to commercialize, whether it blocks the most likely generic design-arounds, whether freedom-to-operate is clear against Sanofi's method-of-use filings and against Indiana University's foundational scaffold estate, and whether the estate is structured to support the pediatric and geographic expansion strategies that drive the back half of the asset's lifecycle value