3.2. Compliance and Reported Adverse Events
muscular cramps
ADVERSE EVENTS
Treatment compliance was determined from the number of pills taken divided by the total days of the treatment period. Some volunteers took extra treatment days due to volunteer availability adjustments in appointments. The mean treatment days in both groups were 87 ± 5 and 88 ± 5 for groups L and A, respectively. The mean compliance in both groups was above 96%, where no difference in compliance was observed between groups (Four volunteers reported treatment adverse events. Two volunteers from Group L (active compound) and one from Group A (placebo group) reported mild gastric discomfort, while one volunteer from Group A reported muscular cramps.The treatment blinding of volunteers was executed by asking each participant in the last appointment if they believed there where in the active or placebo group. Moreover, 23% and 45% of volunteers in Groups L and A, respectively, thought they were in the active group. Therefore, it was determined that volunteer treatment blinding was appropriately conducted. Regarding the researcher blinding, none of the researchers were aware of which group the active compound belonged to until the finalization of the statistical analysis.