Screening | Treatment period | Follow-up | |||
---|---|---|---|---|---|
Visit 1 (day − 7 to − 2) | Visit 2 (day 0) | Visit 3 (day 28 ± 3) | Visit 4 (day 56 ± 3) | Visit 5 (day 84 ± 3) | |
Informed consent | ● | ||||
Inclusion/exclusion criteria | ● | ||||
Randomization | ● | ||||
Drug compliance | ● | ● | |||
Vital signs | ● | ● | ● | ● | ● |
Body measurementa | ● | ● | ● | ● | ● |
Demographic, sociological, and gynecological informationb | ● | ||||
Medical historyc | ● | ● | ● | ● | ● |
General physical examination | ● | ● | ● | ● | ● |
Thermometer measurementd | ● | ● | ● | ● | ● |
Visual Analogue Scale | ● | ● | ● | ● | ● |
Adverse event monitoring | ● | ● | ● | ||
Pattern Identification Questionnaire | ● | ||||
WHOQOL-BREF | ● | ● | ● | ||
Laboratory testse | ● | ● | |||
Chest X-ray scan and ECG | ● | ||||
Medication | ● | ● | |||
Blindness test | ● |