3.1. Study Design
RECRUITMENT, GASTROESOPHAGEAL REFLUX
The recruitment phase included creating a database of potential volunteers according to the inclusion and exclusion criteria. Of the 303 patients in the database, 89 volunteers showed interest in participating in the study and entered the run-in phase. Eight volunteers did not complete the run-in phase due to placebo intolerances, personal issues, and non-response to the next appointment. Eighty-one volunteers were randomized to participate in one of the two groups of the present study (Group A: Placebo and Group L: Active compound) and started the experimental phase. Finally, 38 and 39 volunteers from Groups A and L completed the experimental phase. The leading causes of withdrawal from the study were non-response to appointments in Groups A and L and intolerance to treatment in Group L, mainly due to gastroesophageal reflux. A flowchart of the study is depicted in 