Table 3.
Assessments and follow-up.
| Clinical and laboratory event | V–1a (–4 weeks) | V0 (0 weeks) | V1 (1 weeks) | V2 (2 weeks) | V3 (3 weeks) | V4 (4 weeks) | VF (6 months) |
| Screening | ✓b | —c | — | — | — | — | — |
| Clinical | — | ✓ | — | — | — | ✓ | ✓ |
| Physical examination | — | ✓ | — | — | — | ✓ | ✓ |
| Salivary sample collection | — | ✓ | ✓ | ✓ | ✓ | ✓ | — |
| Hair sample collection | — | ✓ | — | — | — | ✓ | — |
| STAId questionnaire | — | ✓ | — | — | — | ✓ | — |
| ESSe and PSQIf questionnaires | — | ✓ | — | — | — | ✓ | — |
| Inclusion criteria | ✓ | — | — | — | — | — | — |
aV: visit; V–1, screening visit, when inclusion and exclusion criteria will be checked; V0, visit to assess baseline characteristics; V1-V4, visits during the intervention period (every week); and VF, final visit after 6-month follow-up.
b✓: applicable.
cNot applicable.
dSTAI: State-Trait Anxiety Inventory.
eESS: Epworth Sleepiness Scale.
fPSQI: Pittsburgh Sleep Quality Index.