Visit number/title |
Visit 1 |
Visit 2 |
Visit 3 |
Visit 4 |
Visit 5 |
Discontinuation visit |
Schedules days/week/month |
day 1 |
Day 14 |
Day 28 |
Week 16 (month 4) |
Week 28 (month 7) |
At time of permanent treatment discontinuation |
Scheduling Window Days/Weeks/Months: |
|
± 2 days |
± 2 days |
± 2 weeks |
± 2 weeks |
|
Administrative procedures |
Informed consent |
x |
|
|
|
|
|
Informed consent for optional genetic testing (if applicable) |
(x) |
|
|
|
|
|
Informed consent for optional Cardiac‐MRI imaging (if applicable) |
(x) |
|
|
|
|
|
Inclusion criteria/Exclusion criteria |
x |
|
|
|
|
|
Treatment randomization |
x |
|
|
|
|
|
Clinical procedures/Assessments |
Weight/height |
x |
|
|
x |
x |
x |
Vital signs (blood pressure, pulse etc.) |
x |
x |
x |
x |
x |
x |
Physical exam |
x |
x |
x |
x |
x |
x |
Symptoms |
x |
x |
x |
x |
x |
x |
Medical history |
x |
|
|
|
|
|
Family history |
x |
|
|
|
|
|
Prior and concomitant medication review |
x |
x |
x |
x |
x |
x |
Electrocardiogram (12‐lead) |
x |
|
|
x |
x |
x |
Transthoracic echocardiogram |
x |
|
|
x |
x |
x |
Cardiopulmonary exercise testing |
x |
|
|
x |
x |
x |
ECG holter monitoring |
x |
|
|
x |
|
|
Blood work |
x |
x |
x |
x |
x |
x |
Quality of life questionnaires |
x |
|
|
x |
x |
x |
Adverse events monitoring |
x |
|
|
x |
x |
x |
Optional genetic testing (if applicable) |
(x) |
|
|
|
|
|
Optional Cardiac‐MRI imaging for imaging sub‐study (if applicable) |
(x) |
|
|
(x) |
|
|