Visit | V1 | V2 | V3 | V4 |
Day | Day 0 (baseline) | Week 4 | Week 8 | Week 12 |
Informed consent | X | |||
Demographics and medical history | X | |||
Screening and inclusion/exclusion | X | |||
Physical examination | X | X | X | X |
Dose titration | X | X | ||
Vitals, blood pressure and heart rate | X | X | X | X |
Investigations | X | X | X | |
Concomitant medication | X | X | X | X |
Adverse events | X | X | X | X |