Fig 1.
Patient randomization and disposition.
*For safety analyses, the safety-set (SS) population was used. Safety population includes all randomized patients who take at least one dose of the study drug.
**The full-analysis set (FAS) population is a trial population that is as close as possible to the general population for which a test treatment is intended. The FAS population can include individuals who fail to comply with the treatment protocol.
*** The per-protocol population (PPS) is the subset of the FAS population that adhered to the treatment protocol, and consequently, excluding individuals who fail to comply with the treatment protocol.
Table 1.
Demographics of subjects.
Table 2.
Baseline characteristics of modified intent-to-treat patients who had oral candidiasis.
Table 3.
Comparison of the therapeutic efficacy of miconazole and itraconazole between groups.
Table 4.
Summary of overall safety data.
Table 5.
Summary of adverse events.