Table 1

A brief study schedule at every visit.

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


Demographic information taking1


Medical history taking


Inclusion/exclusion criteria check


Physician examination2


Vital sign measurement


Concomitant drugs check


Electrocardiogram(ECG)


Questionnaires for symptoms related to ILI3


Laboratory test4


Study product distribution


Compliance checking


Adverse event monitoring


: Item need to be performed during the visit

1 Sex, date of birth, age, contact address and phone number

2 Include present illness, past history taking

3 Frequency of ILI symptom onset, severity of ILI symptoms, and duration of ILI symptoms

4 Blood test (WBC, RBC, hemoglobin, hematocrit, platelets count, AST, ALT, ALP, gamma-GTP, albumin, BUN, creatinine, glucose, total bilirubin, total protein), urine test (specific gravity, pH, protein, ketone, glucose, bilirubin, urobilinogen, nitrite, microscopic (RBC, WBC))

Ha et al. BMC Complementary and Alternative Medicine 2012 12:10   doi:10.1186/1472-6882-12-10

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