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If participants were missing intake data at one of the follow-up examinations, the mean intake was based on the available intake data.
Noncompliance was defined as missing intake of study drug on more than five consecutive days, failure to take at least 70% of study medication for at least two weeks, or repeated intentional intake of more than the prescribed dose.
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Missing calcium intake data for 229 women (18.7%) were replaced with the study population's mean value.
The numbers of cases for analyses of dietary vitamin D, calcium, and retinol were 772 colon and 448 rectal because of missing nutrient intake values from Greece.
We excluded participants with cancer, implausible energy intakes (reported as <600 or >3600 kcal/day for women, and <800 or >4200 kcal/day for men; 1 kJal=4.18 kJ), or missing alcohol intake at baseline.
We adjusted the main analyses for smoking status (latest record before index date: never, past, current, missing), alcohol intake (latest record before index date: non-drinker, drinker, missing), and body mass index (latest record at least two years before index date: <25, 25-30, ≥30, missing).
We determined the non-valid data as follows: the missing for rice intake, miso soup intake, alcohol intake, ⩾5 items out of 33 food items; and/or extremely low or high total energy intakes (<800 kcal day−1 or >4000 kcal day−1).
Noncompliance with test product intake was defined as having consumed <90% of total spread intake and/or missing more than one intake in the 3 d preceding the study visits.
These factors include administering too much insulin or insulin-producing medications, delayed or missed meal intake or eating a smaller meal than planned, unplanned strenuous exercise, alcohol consumption, and interactions with other drugs.
For adolescents, because there were too many missing data, alcohol intake was not entered for analysis.
Daily assessment included medication review, physical exam (as recorded in medical record or assessed by study personnel when missing), vital signs, intake and output, and labs.
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