Effectiveness was also evaluated as a secondary outcome with a focus on maintenance of effect.
treatment given in the maintenance of effect phase of the core study (MPH-LA or placebo).
Allowing 40% dropout rate in the double- blind maintenance of effect phase, a total of approximately 230 patients were expected to complete the 6-month double- blind maintenance of effect phase.
Additionally, the percentage of MPH-LA- versus placebo-treated treatment failures at the end of the 6-month maintenance of effect phase (week 40) was used as a third primary endpoint to assess the maintenance of effect of MPH-LA.
(3) The double- blind maintenance of effect phase was a 6-month, double-blind, randomized, placebo-controlled, withdrawal phase to evaluate the maintenance of effect of MPH-LA in adults with ADHD.
The real- life dose-optimization phase: a 5-week re-titration period to optimal dose; and the double- blind maintenance of effect phase, a 6-month double-blind randomized placebo-controlled maintenance of effect phase.
During this 6-month maintenance of effect phase, patients with unsatisfactory therapeutic effect were required to discontinue the study.
AEs described here are based on treatment (placebo or MPH-LA) received in the maintenance of effect phase.
The most frequent AEs in all treatment groups during the maintenance of effect phase were nasopharyngitis and headache.
Maintenance of effect is rarely seen in long term follow-up studies of conservative interventions for incontinence [ 16].
Treatment failure rate was significantly lower with MPH-LA (21.3%) versus placebo (49.6%) during the 6-month maintenance of effect phase.
