Safety reports
allergic lesion, aphthous, traumatic
Over the 4-week follow-up period, soft tissue abnormalities which was not presented at baseline were reported by one participant in group SC. After thorough clinical examination and photographic evaluation, the patient consulted a specialist in oral internal medicine. The lesion was localized on the right side of the tongue and appeared to be traumatic; therefore, it was diagnosed as an aphthous lesion, not an allergic lesion. However, the participant voluntarily discontinued the trial.