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 |