TIMEPOINT | Pre-treatment | Post-treatment | 6-month follow-up | 12-month follow-up | 24-month follow-up |
---|---|---|---|---|---|
ENROLMENT: | |||||
Eligibility screen | × |  |  |  |  |
Informed consent | × |  |  |  |  |
Baseline data collection | × |  |  |  |  |
Randomize subjects | × |  |  |  |  |
Allocation | × |  |  |  |  |
INTERVENTIONS: | |||||
Grandio bloc | Â | Â | Â | Â | Â |
Vita suprinity | Â | Â | Â | Â | Â |
ASSESSMENTS: | |||||
Primary outcome |  | × | × | × | × |
Secondary outcomes |  | × | × | × | × |