Day number | −28 to −7 | −6 | −5 | −4 | −3 | −2 | −1 | 1 | 2 | 3 |
---|---|---|---|---|---|---|---|---|---|---|
Informed Consent | X | |||||||||
Selection/Inclusion criteria | X | |||||||||
Medical History | X | |||||||||
Vital Signs | X | X | X | X | X | |||||
Physical Examination | X | X | X | |||||||
12‐lead ECG | X | |||||||||
Laboratory Safety Panel* | X | |||||||||
Urine screen for drugs abuse | X | |||||||||
Baseline blood work | X | |||||||||
Enrolment | X | |||||||||
Admission to CIC | X | X | ||||||||
Hormonal Blood Samples** | X | X | ||||||||
Central pulse pressure and pulse wave velocity | X | X | ||||||||
2‐h Cold or Sham Test | X | X | ||||||||
miRNA Blood Samples** | X | X | ||||||||
Discharge from CIC | X | X | ||||||||
Final visit | X | |||||||||
AE Reporting | X | X | X | X | X | X | X | X | X | X |
*Including haematology (haemoglobin, haematocrit, erythrocytes, neutrophils, basophils, eosinophils lymphocytes, monocytes, leucocytes and platelets), blood biochemistry (sodium, potassium, calcium, chloride, uric acid, creatinine, fasting blood glucose, albumin, total protein, triglycerides, total cholesterol, total bilirubin, alkaline phosphatase, ASAT, ALAT, γGT), immunoserology (HIV, hepatitis B and hepatitis C) and urinalysis (specific gravity, pH, semi‐quantitative ‘dipstick’ evaluation of glucose, protein, ketones, leucocytes and blood).
**Performed right before and at the end of the 2‐h cold (or sham) exposure.