Data items
The primary outcome, relief of symptoms, was measured as a continuous
variable as change in AD severity score from baseline to end of
treatment. Safety outcomes based on AEO were reported as rates/counts;
information whether these were intervention-related was also noted.
This study employed the intention-to-treat principle in order to
minimize type-1 error.25 Missing data were not
imputed. The outcome measures reported at the end-of-treatment were used
for analysis. Probable effect modifiers may stem from the population and
intervention characteristics, including age and dosage.