Preferred term

New/ Fasted
(n= 30)

New/ Semi-fed
(n= 30)

Current/ Fasted
(n= 30)

Current/ Semi-fed
(n= 30)

Overall
(n= 30)

n (%)[1]

nAE[2]

n (%)[1]

nAE[2]

n (%)[1]

nAE[2]

n (%)[1]

nAE[2]

n (%)[1]

nAE[2]

Abdominal Pain

1 (3.3)

2

1 (3.3)

1

2 (6.7)

2

2 (6.7)

2

2 (6.7)

7

Abdominal Pain Upper

0

0

1 (3.3)

1

1 (3.3)

1

0

0

2 (6.7)

2

Nausea

0

0

1 (3.3)

1

1 (3.3)

1

0

0

2 (6.7)

2

Headache

1 (3.3)

1

1 (3.3)

1

2 (6.7)

2

2 (6.7)

2

6 (20.0)

6

Dizziness

0

0

1 (3.3)

1

1 (3.3)

1

2 (6.7)

3

3 (10.0)

5

Burning Sensation

1 (3.3)

1

0

0

0

0

1 (3.3)

1

2 (6.7)

2

Oropharyngeal pain

1 (3.3)

1

0

0

0

0

2 (6.7)

2

3 (10.0)

3




[1] n(%)= Number (percent of subjects)
[2] nAE= Number of adverse events
Table 4: Most frequently occurring AEs in the study (overall incidence of occurrence ≥5%) listed.
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