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Response: Based on the comment received, we do not believe that this medical device is used to deliver a therapy to reduce postoperative pain or produce post-surgical or regional analgesia because the supporting information provided demonstrates that this therapy is used to treat chronic low back pain associated with multifidus muscle dysfunction, rather than post-operative or post-surgical or regional analgesia

Scientists have found that B6 deficiency leads to either less testosterone production or faster breakdown compared to rats getting enough B6 [9]

Roth JD, Roland BL, Cole RL, Trevaskis JL, Weyer C, Koda JE, et al

Recalls & Warnings October 17, 2015 23,000 ER Visits Linked to Supplements: Palpitations, Swallowing Problems, Allergies Common Approximately 23,000 emergency room visits per year are attributed to adverse events linked to the use dietary supplements, according to a large, long-term study by the FDA and the Centers for Disease Control and Prevention (CDC)

Thus, the EFSA set an AI of 4.0 g per day