Period | Screening | Baseline | Treatment (W1–4) | Follow-up (W5 − M6) | ||
---|---|---|---|---|---|---|
Time | W − 1 | W0 | W2 | W4 | M3 | M6 |
Eligibility | X | Â | Â | Â | Â | Â |
Demography and medical history | X | Â | Â | Â | Â | Â |
Physical examination | X | Â | Â | Â | Â | Â |
Informed consent | X | Â | Â | Â | Â | Â |
TNSS | X | X | X | X | X | X |
TNNSS | X | X | X | X | X | X |
RQLQ | X | X | X | X | X | X |
Adverse event | Â | Â | X | X | Â | Â |
Compliance | Â | Â | X | X | X | X |