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SPL UNCLASSIFIED SECTION Adverse Reactions in the Clinical Trials of Adults with Type 2 Diabetes Mellitus SPL UNCLASSIFIED SECTION Pool of Two Placebo-Controlled Clinical Trials in Adults The data in Table 1 are derived from 2 placebo-controlled trials [1 monotherapy trial (SURPASS-1) and 1 trial in combination with basal insulin with or without metformin (SURPASS-5)] in adult patients with type 2 diabetes mellitus [see Clinical Studies (14.2, 14.4)]
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Additionally, in a 30-day placebo-controlled trial in 300 adults (aged 18-65 years), supplementation with the B vitamins (at doses of about 3 to 13 times the RDA, excluding folic acid), vitamin C (1,000 mg/day), calcium (100 mg/day), and magnesium (100 mg/day) was associated with significant improvements in various scores of psychological stress compared to a placebo (139)
GIP and the gut-bone axis physiological, pathophysiological and potential therapeutic implications
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