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These previous studies [12,13,14,15,16,17] had several limitations such as the inclusion of relatively small number of cases, especially for rare type of congenital anomalies (i.e., being underpowered to detect small or moderate risk effect), the use of case-control design (i.e., being more prone to selection bias), or insufficient adjustment for potential confounders (i.e., being more prone to confounding bias)

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Tobacco use directly causes about 6 million deaths and 600,000 deaths indirectly per year [13]