(Protocol Synopsis)

1. (Title,)
2. (Principal Investigator)
3. Address (Study centers

& Address)

4. (study period)
5. / (Objectives) : - /
(primary objective)
- / (secondary objective)
6. (study design)
7.
(Study population
and Sample size at Faculty of Medicine, Chulalongkorn
University)
- (target population)
- (sample size)
8.
(Investigational product, dosage & route of administration)

9.
(Comparator, dosage & mode of administration)
10.
(Duration of participation for each volunteer)
11. (Outcome variables) -primary
-secondary
12. (Statistical method)
13. (Ethical Consideration,

3 The Belmont
Report (
).......
........ ...........)

1.
2.

A4 .
3.

version