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Also, we are finalizing our proposal without modification to specify at 410.36(a)(3)(i)(A) that a brace may include a shoe if it is an integral part of a leg brace and its expense is included as part of the cost of the brace

At 265 lb, exposure ran 25% to 30% lower. On that class-based model, 1 mg in a 155 lb person can approximate the exposure produced by 1.5 mg in the 240 lb trial cohort

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