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

Dental caries

Moderate

Yes

Not related

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

continued

Placebo

1

Premenstrual syndrome

Mild

No

Not related

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

continued

Placebo

1

Dental caries

Moderate

Yes

Not related

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

continued