Visit | Visit of selection | Visit of randomisation | Primary outcome evaluation (visit) | Follow-up visit | End-of-treatment visit | End-of-study visit |
Day of the study | Day 0 | Maximum 3 months after selection | Fifth day of treatment (±1 day) | Weekly until end of treatment | Last day of treatment | 2 weeks later after ending treatment* |
Selection criteria meeting | X | |||||
Informed consent signing | X | |||||
Genetic sample | X | |||||
Randomisation | X | |||||
Starting treatment | X | |||||
Voriconazole serum levels | X | X† | ||||
Lab analysis‡ | X | X | X | X | X | |
Electrocardigram | X | X | X | X | X | |
AE evaluation | X | X | X | X | X |
*Patients who after 3 months continue being treated, End-of-study visit will be done on the last day of third month.
†According to physician criteria.
‡Analysis including liver enzymes.
AE, adverse events.