Screening | Treatment period | Follow-up | |||
---|---|---|---|---|---|
Visit 1 (day − 7 through − 2) | Visit 2 (day 0) | Visit 3 (day 28 ± 3) | Visit 4 (day 56 ± 3) | Visit 5 (day 84 ± 3) | |
Informed consent | ● | ||||
Eligibility criteria | ● | ||||
Randomization | ● | ||||
Medication compliance | ● | ● | |||
Vital signs | ● | ● | ● | ● | ● |
Body measurementsa | ● | ● | ● | ● | ● |
Collection of demographic, sociological,b and gynecological information | ● | ||||
Medical history | ● | ● | ● | ● | ● |
General physical examination | ● | ● | ● | ● | ● |
Thermometer measurementc | ● | ● | ● | ● | ● |
VAS | ● | ● | ● | ● | ● |
Monitoring of AE | ● | ● | ● | ||
Questionnaire of Pattern Identification | ● | ||||
Questionnaire of Cold Hypersensitivity | ● | ||||
Cold stress test | ● | ● | |||
WHOQOL-BREF | ● | ● | |||
Laboratory testsd | ● | ● | |||
Chest X-ray & ECG | ● | ||||
Medication | ● | ● | |||
Test of blindness | ● |