Table 1 Schedule for treatment and outcome measurements

Visit

1

2

3

4–12

13

14

15–18

19

20

21

22

Week

1

1

1

2–4

5

5

6–7

8

8

9

13

Informed consent

●

Inclusion/exclusion criteria

●

Laboratory test^a

●

●

Vital signs

●

●

●

●

●

●

●

●

●

●

●

●

Demographic characteristics

●

Medical history/BMI

●

SRRS

●

SDTS

●

●

●

Random allocation

●^b

Change of history

●

●

●

●

●

●

●

●

●

●

●

Treatment

●

●

●

●

●

●

●

●

●

HAM-D

●

●^b

●^b

●

●

BDI

●^b

●^b

●

●

EQ-5D

●^b

●^b

●

●

ISI

●^b

●^b

●

●

STAI

●^b

●^b

●

●

MYMOP2

●^b

●^b

●

●

EEG

●^b

●^b

●

●

Pattern identification

●^b

Safety assessment

●

●

●

●

●

●

●

●

●

●

●

Blinding test

●

●