Identification and initial approach (including provision of PIS)
|
X
| | | | | |
Eligibility criteria checked (as per routine clinical practice)
|
X
| | | | | |
Written informed consent (including discussion of study in detail, questions answered)
| |
X
| | | | |
Physical examination (height,e weight, blood pressure, pulse)
| | |
X
| |
X
| |
Venepuncture
| | |
X
b
|
X
c
|
Xd
| |
Clinical history (relevant medical history, medication list/history)
| | |
X
| | | |
Participant-completed questionnaires (ThyDQoL, ThySRQ, EQ-5D)
| | |
X
| |
X
| |
Nurse-administered questionnaires (FRAT, TUG)
| | |
X
| |
X
| |
Randomization (after all eligibility criteria checked and written informed consent obtained)
| | |
X
| | | |
Study medication prescribed and dispensed (following LT4 dose assessment at visit 2 only)
| | |
X
|
X
| | |
Study medication compliance checks
| | | |
X
|
X
| |
Concomitant medication
| | |
X
|
X
|
X
| |
Adverse events
| | | |
X
|
X
| |
Serious adverse events
| | | |
X
|
X
|
X
|