Figure 1.

Disposition of the study population. ^aFor 8 participants, it is not known whether treatment was started; these participants were included in the FAS. The LOS comprises those participants who failed to satisfy the selection criteria for the study and never received any treatment. These data were not included in the subsequent statistical analysis. ^bTreatment was completed if a subject applied at least 1 patch after day 14 of cycle 13 according to the diary, or if the completion date was available and was at least 350 days after start of study treatment. FAS indicates full analysis set; LOS, listing-only set.