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Since mild cognitive impairment is well reported to be underestimated but influencing patients' ability to express subjective experience of well-being and symptoms, cognitive function will be monitored throughout the study.
Cardiac function will be monitored using a 12-lead ECG.
Acoustic function will be monitored until 24 months.
Incidences of abnormal hepatic function will be monitored in Phase II/III trials.
In addition, biomarkers associated with disease recurrence, including stress hormones, estrogen status, inflammatory markers and indices of innate and adaptive immune function will be monitored.
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All resource use will be monitored prospectively.
Laboratory examinations, including routine blood test, urine and stool tests, serum potassium, liver function (AST, ALT), will be monitored at baseline, 3, 6, 9 and 12 months.
Specifically, cell proliferation, alkaline phosphatase activity and mineralization will be monitored as a function of BG content (0%, 10%, 50% by weight) and culturing time.
At these consultations lung function and BMI will be measured, and smoking status, comorbidity, number of exacerbations in the previous year and since previous visit will be monitored.
He will be monitored electronically.
It will be monitored for 10 years.
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