Study phase | Time-point | Time after start | Action |
---|---|---|---|
Recruitment | Â | Â | Assess for eligibility |
 |  | Randomization | |
 |  | Send information | |
 |  | Complete informed consenta | |
Treatment | T(1) | 6Â weeks | Questionnaires |
T(2) | 3Â months | Questionnaires, interview, saliva collection | |
T(3) | 6Â months | Questionnaires, saliva collection | |
T(4) | 9Â months | Questionnaires, interview, saliva collection, observation, autonomic nervous system recording | |
Follow-up | T(5) | 12Â months | Questionnaires |
T(6) | 24Â months | Questionnaires |