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Based on the information provided in the comment and our review of the application, we agree with the applicant that the aprevo Cervical ACDF System meets the criterion because the referenced components are only intended to be used with the aprevo Cervical ACDF System, commercially available insertion instruments or screws cannot be utilized with the device, and the use of these components is necessary and/or required to furnish or deliver the primary procedure(s) with which it is used, and are not supplies incident to the procedure

Individuals who benefit most from B12 shots for diagnosed deficiency are patients with conditions that impair gastrointestinal absorption, such as pernicious anemia, tropical sprue, or pancreatic insufficiency

The exclusion of patients with COPD and asthma in key daratumumab studies and the incidence of bronchial hyperreactivity AEs seen in early trials resulted in the recommendation for post-administration prophylaxis with bronchodilators and inhaled corticosteroids in patients with a history of COPD [13, 65]

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Statistical Software 36, 148