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While a high-fat diet increases cholesterol secretion into the bile, which can lead to sludge and stone formation, 9 rapid weight loss and less frequent, low-fat meals also contribute to sludge and stone formation, as discussed later

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We calculated a sample size of 120 patients needed (60 in each group) to be 80% certain that the upper limit of a 1-sided 95% CI will exclude a difference in favor of the standard group of more than 3% (the noninferiority limit) using Farrington-Manning score test