Table 2 Summary of frequency of adverse events across the studies

Any AE^a

8 (88.9)

5 (83.3)

6 (100)

6 (100)

25 (92.6)

SAEs^a

1(11.1)

0 (0)

0 (0)

0 (0)

1 (3.7)

DAEs^a

2 (22.2)

0 (0)

0 (0)

0 (0)

2 (7.4)

Total number of AEs

31

7

18

15

71

n = 6

400 μg

1000 μg

Total (%)

n = 6

n = 6

n = 18

Any AE^a

3 (50.0)

6 (100.0)

4 (66.7)

13 (72.2)

SAEs^a

0 (0)

0 (0)

0 (0)

0 (0)

DAEs^a

0 (0)

0 (0)

0 (0)

0 (0)

Total number of AEs

3

10

7

20

n = 1

n = 3

n = 4

Any AE^a

1 (100)

3 (100)

4 (100)

SAEs^a

0 (0)

0 (0)

0 (0)

DAEs^a

0 (0)

1 (33.3)

1 (25.0)

Total number of AEs

1

8

9