Group

Participant number

Adverse event

Severity

Treatment

Causal relation with the study substance

Reason for causal conclusion

Continuation or discontinuation of the trial

(symptom)

Active

1

Fever, Pharyngeal pain

Moderate

Yes

Not related

Occasional event due to an infectious disease and was probably not associated with the study substance.

continued

Active

1

Gastroenteritis

Mild

No

Not related

The participant’s symptoms improved even while continuing to ingest the study substance. The study substance was deemed to be unrelated to the symptoms.

continued

2

Cough

Moderate

Yes

Not related

Occasional event due to an infectious disease and was probably not associated with the study substance.

continued

3

Acute otitis media

Moderate

Yes

Not related

Occasional event and was probably not associated with the study substance.

continued

Active

1

Common cold

Moderate

Yes

Not related

Occasional event due to an infectious disease and was probably not associated with the study substance.

continued

Active

1

Treatment of pus from gums

Moderate

Yes

Not related

Occasional event and was probably not associated with the study substance.

continued

Active

1

Increase of TG, Increase of body weight

Mild

No

Not related

The participant’s triglyceride level was believed to be temporarily elevated because of diet. This was determined to be unrelated to the study substance.

continued

Placebo

1

Pollinosis

Moderate

Yes

Not related

Occasional event and was probably not associated with the study substance.

continued

Placebo

1

Pollinosis

Mild

No

Not related

Occasional event and was probably not associated with the study substance.

continued

Placebo

1

Loose bowel movement

Mild

No

Not related

The symptoms occurred after conclusion of ingesting the study substance. It was concluded that the study substance was unrelated to the symptoms.

continued

2

Loose bowel movement

Mild

No

Not related

The symptoms occurred even after the conclusion of ingesting the study substance It was concluded that the study substance was unrelated to the symptoms.

continued

Placebo

1

Bleeding piles

Moderate

Yes

Not related

Occasional event and was probably not associated with the study substance.

continued