Table 1.

Definitions of baseline and endpoint in the two study periods

Open-label baseline
Patients recruited from SPD489-325 in Europe (n = 222)	Visit 0 (week 0) of SPD489-325 (after screening and washout as part of SPD489-325)
Additional US patients (n = 40)	Visit 1 (week 0) of the present study (after screening and washout as part of the present study)
Open-label endpoint
Patients under the original protocol	The last on-treatment visit with valid data, up to and including visit 17 (week 52), or early termination
Patients who switched protocols	The last on-treatment visit with valid data, up to and including visit 3R (week ≥26), or early termination
Patients under the revised protocol	The last on-treatment visit with valid data, up to and including visit 3R (week 26), or early termination
Randomized-withdrawal baseline	Visit 3R (week 0 of the randomized-withdrawal period)
Randomized-withdrawal endpoint	Visit 9R (week 6 of the randomized-withdrawal period) or early termination

See Fig. 1 for schedule of study visits. Numbers are those in the full analysis set. SPD489-325 was the previous 7-week, European, phase III study of LDX

R revised