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At the initial study visit, eligibility criteria will be confirmed and informed consent obtained.
At the baseline visit, eligibility will be re-confirmed in addition to randomization and beginning of treatment in the evening.
At this visit eligibility is confirmed, written informed consent is obtained and baseline data are collected for those consenting to participate.
Data from years 2003 and 2004 were used to determine prior diagnosis of diabetes, prediabetes, preexisting comorbidities, and pregnancy and to determine visit eligibility.
The study included a screening visit and two study visits (visit 1 at week 0 and visit 2 at week 4), and one telephone contact at week 2. At the screening visit, eligibility of the subjects was assessed and written informed consent obtained.
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If consent documentation and baseline survey measures are completed in separate visits, eligibility criteria are reviewed immediately prior to survey administration to ensure continued eligibility.
CMS also gives details for that visit, radiologist eligibility criteria and imaging centre eligibility criteria [ 27].
During the study visit patient eligibility was confirmed and informed consent was obtained.
Phase 1 consisted of 4 study visits: 1 screening visit, 2 eligibility visits, and 1 follow-up visit after 6 weeks of treatment with the first medication.
At the screening visit, patient eligibility was assessed according to the inclusion/exclusion criteria (including the criteria in Table 3 ).
All potential study participants attended an enrollment visit where eligibility was verified, the study was described, and requirements of participation were reviewed.
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