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Procedure at baseline entailed the collection of sociodemographic, anthropometric, clinical, and laboratory data.
Procedure At baseline, participants received questionnaire booklets by mail in two waves: the first assessing socio-demographics, clinical data and diabetes-specific distress.
Wherever possible, both interviews were conducted by the same interviewer (92% of all interviews) to enable consistency of the interview procedure at baseline and follow-up.
Patients will be motivated to undergo a SIS or GIS, however saline or gel instillation will be omitted in case patients experienced too much discomfort during this procedure at baseline (see Fig. 4 for the flowchart).
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Table 1 summarizes the characteristics of the patients and procedures at baseline.
Table 1 Characteristics of the patients and procedures at baseline, as well as short-term patient outcomes No. [95% CI] All patients 203 (100) [98.1–100] AKI stage ≥1a within 48 h 95 (46.8) [40.1–53.7] No AKIa within 48 h 108 (53.2) [46.3–59.9] P value Characteristic Male sex no.
Patients will undergo the same assessment procedures at baseline and three months later.
Medical history and biometric measurements Procedures at baseline and follow-up were identical [ 8].
Each subject will undergo the following procedures at baseline assessment and again at 12 and 24 weeks.
Techniques and procedures: At baseline, prior authorization was obtained from the Secretary of Education to visit local elementary schools.
Individuals with physician-diagnosed clinical cardiovascular disease (i.e., heart attack, angina, stroke, congestive heart failure, and atrial fibrillation) or cardiovascular-related procedures at baseline were excluded.
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