(4) The terms reduced cholesterol, reduced in cholesterol, cholesterol reduced, less cholesterol, lower cholesterol, or lower in cholesterol except as limited by 101.13(j)(1)(i) may be used on the label or in labeling of foods or foods that substitute for those foods as specified in 101.13(d), excluding meal products as defined in 101.13(l) and main dish products as defined in 101.13(m), provided that: (i) For foods that contain 13 g or less of total fat per reference amount customarily consumed, per labeled serving, and per 50 g if the reference amount customarily consumed is 30 g or less or 2 tablespoons or less (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50-g criterion refers to the as prepared form): (A) The food has been specifically formulated, altered, or processed to reduce its cholesterol by 25 percent or more from the reference food it resembles as defined in 101.13(j)(1) and for which it substitutes as specified in 101.13(d) that has a significant (i.e., 5 percent or more) market share
Quantitative variables and statistical methods Demographic characteristics and clinical data including a history of comorbidities were summarized using descriptive statistics
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