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5 The rule requires the submission of baseline or demographic characteristic measured in the clinical trial, including age, sex/gender, race, ethnicity (if collected under the protocol) for trials that are required to be registered under Section 11.22 (Phase 1 trials are excluded), 6 for reporting purposes via ClinicalTrials.gov

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The intervention reduced the TDD from 43.3 units to 22.55 units, which was significant