3. Results
fecal impaction
The acquisition of subjects for the clinical study is reported in The PP analysis was conducted on 61 and 58 subjects, respectively, for the PL and PG groups.Most of the dropouts were due to personal reasons. In two cases administered with the PL, and in three cases administered with the PG, the treatment was withdrawn due to COVID-19. In one case only in the PG group, the treatment was withdrawn due to the onset of fecal impaction (fecalomas).The compliance was >95% in all subjects.The clinical results were reported considering the baseline and 90-day values of treatment for the PP (per protocol) subjects only.However, no differences were found between the PP and ITT (intention-to-treat) measures.