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The EU update affects a section on the permission to import or manufacture a medical device that does not have a predicate device

Copper regulates the function and folding of SOD1, maintaining normal immune cell function, while excessive copper accumulation or deficiency changes immune cell activation and pro-inflammatory responses, leading to increased neuroinflammation, thereby promoting the occurrence of neurodegeneration (116)

L., Xu, H., Huang, Y

Notably, a study involving approximately 276,000 participants from the UK Biobank cohort revealed that permanent night shift work, a condition acknowledged to reduce 24-hour melatonin levels [41], was associated with a 1.5-fold higher risk of developing AD during a median follow-up of 9 years [42]

6 Conclusions Copper, an essential trace metal, plays a pivotal role in maintaining normal hematopoietic function, promoting connective tissue formation, and facilitating cellular metabolism within the human body (162)