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Effective as of a date specified by the Secretary, but no earlier than January 1, 2012, a copy of: A State-issued Notice of Action, Notice of Determination, or Notice of Enrollment that includes the beneficiarys name and home and community based services (HCBS) eligibility date during a month after June of the previous calendar year

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The most commonly reported side effects in the Phase 2 trial were gastrointestinal, including nausea, vomiting, diarrhoea, and constipation, which were generally mild to moderate and most prominent during dose escalation