| Study period | ||||||
---|---|---|---|---|---|---|---|
Run-in | Treatment | Follow-up | |||||
Time point | -2W | 0W | 1W | 2W | 3W | 4W | 104W |
Visit | Visit1 | Visit2 | Visit3 | Visit4 | Visit5 | Visit6 | Visit7 |
Enrollment | |||||||
 Eligibility screen | √ | √ |  |  |  |  |  |
 Informed consent | √ |  |  |  |  |  |  |
 Demographics | √ |  |  |  |  |  |  |
 Randomization |  | √ |  |  |  |  |  |
Intervention | |||||||
 Experimental group |  |  |  |  |  |  |  |
 Control group |  |  |  |  |  |  |  |
Assessments | |||||||
 iPFS |  |  |  |  |  | √ | √ |
 Neurological function |  | √ | √ | √ | √ | √ | √ |
 QoL |  | √ | √ | √ | √ | √ | √ |
 OS |  |  |  |  |  | √ | √ |