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FDA concluded that the DSIP narcolepsy evidence was limited by case-level or uncontrolled designs, subjective variability and inconsistent treatment schedules

Diet-induced obese mice were switched from an obesity-promoting diet to a lower-fat diet and compared with groups receiving diet change alone or diet change plus 5-Amino-1MQ

With high odds ratios and wide confidence intervals, the overall odds ratios from the random effects model (104.55) and the common effect model (115.91) demonstrate a significant increase in the incidence of nausea with ROSE-010 administration ( Figure 7 )

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