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Baseline DSQ scores were recorded during the 14-day period before randomization.
Patients undergo a 4-week medication washout period before randomization to renal denervation (treatment) or renal angiogram (sham).
Using a controlled cross-over study design, 85 subjects completed a 4-week healthy diet run-in period before randomization to one of two 4-week intervention sequences in which they either consumed 2 green kiwifruit a day plus a healthy diet (intervention) or consumed a healthy diet alone (control).
Reasons for exclusion during the run-in period before randomization are shown in Supplementary Fig. 1.
Fifty-six patients completed test meal 1 at the end of the lead-in period before randomization.
However, they had a run-in period before randomization in which 52 out of 616 (8%) failed.
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These patients had had at least one exacerbation despite the IFNβ therapy, during the 12-month period before the randomization.
Seven troops agreeing to participate completed a pretest time 1 assessment within a two-week period in October before randomization.
To assess the meal-induced responses of the biomarkers at baseline and ensure that the two groups had similar post-meal responses, test meal 1 was given at the end of the lead-in period (2 10 days before randomization).
Patients who were receiving beta-blockers or ivabradine entered a 2-week washout period from these drugs before randomization.
In addition, although patients may have taken laxatives or stool softeners before study enrollment, response to previous therapies was not recorded at screening, and there was no requirement for a trial period of conservative therapy before randomization.
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