Procedures and outcome measurements
CRF
ADVERSE EVENTS, CRF
Participants were required to visit one of the two clinic centers four times. The first visit was for screening of eligibility; second visit (day 0) for baseline assessment and randomization; third visit (day 30) for mid-point efficacy, safety, and dosing compliance assessment; and fourth visit (day 60) for end-of-trial efficacy, safety, and dosing compliance assessment.At the 2nd visit (day 0, baseline), participants were allocated with the coded kits containing bottles of the investigational product for the entire trial and were advised to take the capsules orally with water of ambient temperature once daily before breakfast. They were instructed to maintain the record of dosing details in the participant diaries. To confirm participant’s dosing compliance with the protocol, the trial staff at the two centers checked the number of capsules dispensed and returned at 3rd visit (day 30) and 4th visit (day 60) to record the number of capsules consumed in Case Report Form (CRF), and reviewed participant dairies. Treatment compliance was considered adequate if participants had used on average at least 75% and no more than 125% of scheduled doses.Participants could be removed from the trial at any time for any of the following reasons: participant’s withdrawal of informed consent and withdrawal by his/her own free will to not continue in the trial, participant’s non-compliance with dosing schedule (75-125% non-compliance), the development of adverse events requiring the withdrawal of the trial, and pregnancy confirmed anytime during the trial. Reasons why subjects were discontinued from the clinical trial were documented in the CRF.