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However, we disagree with the applicant's assertion that we deviated from our approach of assessing whether a device is integral regarding neurostimulators with rechargeable and non-rechargeable batteries because neurostimulators require a power source to operate and the batteries are, therefore, integral to the device regardless of how they are charged

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A small subset of "sentinel" participants is dosed first, before the rest of the cohort, as an additional safeguard