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The FDA and KMFDS approved a phase III, multicenter, randomized, double-blind, sham-procedure-controlled trial, conducted exclusively in South Korea [166] NCT 04745299, KCT0005954, which did not meet primarily efficacy outcomes [167], though long-term follow-up and safety reporting continues through 2026

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361 Human studies have also shown it has potential to intersect with the stress axis and thinking patterns, both of which may impact symptoms of IBS

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1,4 Painful DN, often associated with SFN, occurs in approximately 25% of diabetes patients and significantly impacts the quality of life due to chronic pain and sensory disturbances