Randomization and intervention
Participants were randomly assigned in a 7:3 ratio to the SA-ER group and the placebo group, and all participants received either SA-ER or placebo. As in our recent phase II/III study, the investigational products used were an SA-ER tablet containing 500 mg of aceneuramic acid and a matching placebo tablet. Participants were administered four SA-ER or placebo tablets three times per day (6 g/day) orally, in the morning, early evening, and at bedtime after a meal (within 30 min after intake of food).