Table 1 Schedule of events for ThyrAMI 2

Identification and initial approach (including provision of PIS)

X

Eligibility criteria checked

X

Written informed consentǂ

X

Physical examination (height ****, weight, BP, pulse)

X

X

Venepuncture

X*

X**

X**

X**

X**

X*

Clinical history (medical history, medication list)

X

Questionnaires (SF12, MLWHFQ, CES-D) completed

X

X

Safety checks (ECG, pulse oximetry and NYHA assessment

X

X

X

X

X

X

Cardiac MRI

X

X

EndoPat, Badimon chamber, VerifyNow and TEG analysis

X

X

Randomisation (after written informed consent obtained) and study drug dispensation

X #

Study medication prescribed and dispensed (following LT4 dose assessment at visits 2 to 5 only)

X

X

X

X

Study medication compliance checks

X

X

X

X

X

Concomitant medication

X

X

X

X

X

Adverse events

X

X

X

X

X

X

Serious adverse events

X

X

X

X

X

X