Variable | Inclusion baseline | Follow-up 6 weeks ± 1 week | Follow-up 3 months ± 2 weeks | Follow-up 6 months ± 2 weeks | Follow-up 12 months ± 2 weeks | Follow-up 18 months ± 2 weeks |
---|---|---|---|---|---|---|
Visit | x | x | x | x | ||
Weight | x v | x v | x v | x v | ||
Medical treatment | x v | x v | x v | x v | ||
ThyPRO | x r | x r | x r | x r | x r | x r |
TSH, FT4, FT3 | x s | x s | x s | x s | ||
TPO-Ab | x s | x s | x s | x s, | ||
LT4 dosage | x v | x v | x v | x v | ||
Immunological and oxidative stress biomarkers | x s | x s | x s | x s | ||
Selenium | x s | x s | x s | x s | ||
Creatinine/iodine ratio in spot urine | x s | |||||
Tablet count | x v | x v | ||||
Consumption of additional selenium | x v | x v | x v | x v | ||
Adverse reactions | x v | x v | x v | |||
Serious adverse reactions and events (SARs, SUSARs and SAEs) | x p |