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Despite these measures, there was an approximate two to three week lag between CATI completion and diary commencement.
Case patients were individuals who were free of cancer (except non-melanoma skin cancer) at the date of food diary commencement and who developed CRC at least 12 months after the date of diary commencement and before the end of the study period, defined for each study centre by the latest date of complete follow-up for both cancer incidence and vital status.
Follow-up time for matched controls was also required to be at least as long as that for the case, with follow-up time defined as the time from the date of diary commencement to the date of CRC diagnosis for cases and the time from date of diary commencement until the end of follow-up for controls.
Matched controls were selected at random from the appropriate stratum of the set of all cohort members who were free of CRC at the end of follow-up (due to death or censoring) and free of all cancer (except non-melanoma skin cancer) at the date of diary commencement.
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Those patients successfully recruited will be randomised at this stage.>> Trial participants will perform their first self-administration of study agent and first blood glucose measurement, which will be recorded in their patient diary, at trial commencement (Week 0).
Participants will also be asked to complete a weekly diary documenting drastic changes in diet, commencement or cessation of negative behaviours such as alcohol consumption and smoking, number of hours spent exercising, changes in medication, significant positive or negative life events, adverse events, and compliance to yoga program.
Intervention and wait-listed control participants will be required to complete a 4-day food diary, both in the week prior to commencement of the intervention or wait-listed period and again at 12 weeks.
There was a two week lag between the administration of the first batch of CATIs and commencement of the first batch of diaries.
The actigraphy data, combined with patient diaries, were used to corroborate the absence of daytime napping and to define the commencement and termination of the daytime awake and nocturnal asleep spans so the respective blood pressure means for each subject could be accurately determined.
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