FAS dataset (mean difference, -0.55, SD 3.6, P<0.05), and in completers (mean difference, -0.53, SD 2.44, P<0.01). AUC values were lower for completers (means, 2.12 and 2.64 for proactive arms and reactive arms, respectively) than dropouts (means, 4.22 and 4.59 for proactive arms and reactive arms, respectively). The difference between the two study arms was not statistically significant for dropouts (mean difference, -0.37, SD 4.19, P=0.709).
AUC values were estimated for BSA values observed during ‘remission’ versus periods of ‘relapse’ in the FAS (n=512) and in completers (n=246) as seen in Table 3. In the FAS, patients in the proactive arm had a statistically significant lower BSA during remission than those in the reactive arm (mean AUC difference, -0.50, SD 3.53, P<0.05). This result was also seen in the completers (mean AUC difference, -0.52, SD 2.36, P<0.01). The AUC BSA in patients experiencing relapse was lower in the proactive arm than in the reactive arm, but the difference was not statistically significant neither in the FAS (AUC difference, -0.21, SD 3.53, P=0.72) nor in completers (AUC difference, -0.07, SD 2.75, P=0.46).
Mean BSA values for patients who dropped out from the study were calculated at time of dropout (Table 4). Patients who dropped from the proactive arm had lower mean BSA than patients dropping out from the reactive arm, however the difference was not statistically significant (P=0.167). Main reasons for dropout did not differ markedly between treatment arms (Table 5).
