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Authors' contributions The first draft of the manuscript was written by DBV

Here are the most practical approaches

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By making these tools publicly available, the agency aims to help sponsors better prepare complete, compliant applications and prevent the procedural oversights that can cause costly delays in bringing new therapies to patients

Alongside the medication, the protocol includes foundational support: Protein intake of 0.7-1g per pound of body weight to preserve lean mass Consistent sleep hygiene to support thyroid and cortisol regulation Breathwork practices to reduce systemic stress and support parasympathetic tone Moderate resistance training to build metabolically active tissue without triggering flares These aren't optional add-ons