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Additionally, a Phase 2b clinical trial (ORCA-1) found that smokers treated with cytisinicline showed a greater reduction in cigarettes smoked compared with placebo and that cytisinicline was safe and well tolerated with no serious adverse events reported

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of this rulemaking, we propose to expand Hepatitis B vaccine coverage by revising our regulatory definition for intermediate risk groups by adding a new paragraph to include individuals who have not previously received a completed hepatitis B vaccination series or whose vaccination history is unknown ( 410.63(a)(2))

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