Outcomes | Baseline | Treatment | Follow-up | |||||
---|---|---|---|---|---|---|---|---|
1Â weeks | 2Â weeks | 3Â weeks | 4Â weeks | 8Â weeks | 12Â weeks | 16Â weeks | ||
Patients | ||||||||
 Informed consent | × |  |  |  |  |  |  |  |
 Screening | × |  |  |  |  |  |  |  |
 Sign informed consent | × |  |  |  |  |  |  |  |
 Randomization | × |  |  |  |  |  |  |  |
Primary outcome | ||||||||
 OTE |  |  |  |  | × |  |  |  |
Second outcome | ||||||||
 OTE |  | × | × | × |  | × | × | × |
 Symptoms | × | × | × | × | × | × | × | × |
 NPI | × |  |  |  | × | × |  | × |
 HADS | × |  |  |  | × | × |  | × |
 Adverse events |  | × | × | × | × |  |  |  |