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We refer readers to section XXIII.C

The Bridge Program is a temporary solution until BALANCE Model starts

If nausea and GI symptoms feel unbearable at a particular dose level, the correct move is to hold at that dose longer, not to push through to the next escalation

J., et al., RoB 2: A Revised Tool for Assessing Risk of Bias in Randomised Trials, BMJ 366 (2019): e14898, 10.1136/bmj.14898

While this requirement may narrow some claims, it streamlines the litigation as the court prepares to address broader issues like federal preemption and general causation