3.5. Adverse Events
dysuria, ’ adverse reactions, heartburn
ADVERSE EVENTS, UPPER RESPIRATORY INFECTION, ORAL LEUKOPLAKIA
All study participants’ adverse reactions to the test product or placebo were documented at each visit. No serious adverse events were reported throughout the trial. However, five mild adverse events were reported by four subjects. The reported adverse events in the BRE group were upper respiratory infection (one case), dysuria (one case), elevated T-PSA (one case), heartburn (one case), and oral leukoplakia (one case). However, the relationship with the investigational product has been ruled out for all five mild adverse events. The incidence rate of adverse events did not differ significantly between the BRE and placebo groups (