Screening Visit 1 | Baseline Visit 2 | Visit 3 | Visit 4 | Visit 5 | Follow up (Visit 6) | |
---|---|---|---|---|---|---|
D-21 ~D-1 | Week 0 D0 | Week 4 D28 | Week 8 D56 | Week 12 D84 | Week 17 D119 | |
Informed consent form | â—¯ | |||||
Demographic information taking 1 | â—¯ | |||||
Medical history taking | â—¯ | â—¯ | â—¯ | â—¯ | â—¯ | |
Inclusion/exclusion criteria check | â—¯ | â—¯ | ||||
Physician examination 2 | â—¯ | â—¯ | ||||
Vital sign measurement | â—¯ | â—¯ | â—¯ | â—¯ | â—¯ | |
Concomitant drugs check | â—¯ | â—¯ | â—¯ | â—¯ | â—¯ | |
Electrocardiogram(ECG) | â—¯ | â—¯ | ||||
Questionnaires for symptoms related to ILI 3 | â—¯ | â—¯ | â—¯ | â—¯ | â—¯ | â—¯ |
Laboratory test 4 | â—¯ | â—¯ | ||||
Study product distribution | â—¯ | â—¯ | â—¯ | |||
Compliance checking | â—¯ | â—¯ | â—¯ | |||
Adverse event monitoring | â—¯ | â—¯ | â—¯ | â—¯ |