T0 | T1, T2, T3 | T4, T5 | T6 | |
---|---|---|---|---|
Inclusion | Administration | Post-administration | Day-14 | |
Consent | x | |||
Randomization | x | |||
Clinical examination | x | |||
NPIS | x | x | x | x |
NPSI | x | x | x | x |
ECG | x | x | ||
Tolerance | x | |||
Opioid consumption | x | x | x | |
MDASI | x | x | ||
Adverse events | x | x | x | |
Intercurrent events | x | x | x | |
Satisfaction PTSS | x | x | x |