Assessment and evaluation schedule of this study
12 Weeks before randomisation | Day 0 (Week 0) | Week 8 Week 16 | Week 24 | Week 32 Week 40 | Week 48 | |
Diagnosed with clinical FH (pre-registration) | Randomisation (registration) | Main period | Primary endpoint | Observational period | Trial end | |
Informed consent | X | |||||
Patient background | X | |||||
Check adverse events |
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Height | X | |||||
Body weight | X | X | X | X | X | X |
BP/HR | X | X | X | X | X | X |
Symptoms | X | X | X | X | X | X |
Physical examination | X | X | X | X | X | X |
Blood tests | ||||||
Lipid profile | X | X | X | X | X | X |
FPG/HbA1c | X | X | X | X | X | X |
CBC | X | X | X | X | X | X |
Chemistry | X | X | X | X | X | X |
Genetic testing | X | |||||
Lipid-lowering therapy regimen | X | X | X | X | X | X |
PSQ-18 | X | X | X | X | ||
Smoking status | X | X | X | X | X | X |
BP, blood pressure; CBC, complete blood counts; FH, familial hypercholesterolemia; FPG, fasting plasma glucose; HR, heart rate; PSQ-18, the Patient Satisfaction Questionnaire Short Form.