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The exclusion criteria at 425.401(b) apply for purposes of determining beneficiary eligibility for alignment to an ACO based on the beneficiary's designation of an ACO professional as responsible for coordinating their overall care under paragraph (e) of this section, regardless of the ACO's assignment methodology selection under 425.226(a)(1)

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In our experience, if you use proper sterile procedures and refrigerated storage, you can continue sampling from the same reconstituted vial for 3+ months

Combination with Other Therapies: TB-500 nasal spray can be used as a standalone therapy or in combination with other treatments or therapies