Study Diagnostics and Meta-Analysis For both cohort and self-controlled case-series analyses, we used a comprehensive set of study diagnostics, eg, preexposure patient characteristic balance, empirical clinical equipoise, minimum power requirement, and negative control experiments, to evaluate systematic error, residual bias, reliability, and the generalizability of our comparisons
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10.1016/S0140-6736(80)91773-0 Khoo SH, Leyland MJ: Cerebral edema following acute sodium valproate overdose