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Reasons for screening failure included inability to meet entry criteria (K-MMSE score below 12 or above 26, n =13), withdrawal of consent ( n =5), and unstable medical conditions ( n =6) (Fig

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15 percent, cardiovascular disease

Regulatory guidance from the Food & Drug Administration (FDA) and WHO emphasizes that proper aseptic technique, storage procedures, environmental controls, and documentation practices remain essential regardless of the presence of preservatives