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A random effects model was selected to perform the meta-analyses, results were expressed as weighted mean differences for continuous outcomes and relative risks for dichotomous outcomes, both with 95% confidence intervals, and with I2 values and P values as markers of heterogeneity

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Furthermore, the ad also provoked two senators, a Democrat (Dick Durbin, D-IL) and Republican (Roger Marshall, MD, R-KS), to write the FDA a letter expressing the legislators concerns about the lack of safety information in the ad threatening potential enforcement action