2.2. Study Design
The study was a randomized, double-blinded, placebo-controlled, parallel-group study with 90 days of clinical intervention. The two groups were randomly assigned to patients consecutively in chronological order of enrollment, according to the numbering from 1 to 150. The relative product packages provided by the production workshop were identified only with a number from 1 to 150, corresponding to the patient; the composition was only known to the manufacturing workshop.