Assessment description | Screening | Baseline/randomisation | 12-month visit | Final visit |
---|---|---|---|---|
Informed consent | X | |||
Eligibility | X | X | ||
Reasons for non-participation | X | X | ||
Demographics, medical history, | X | |||
Medications, physical examination, vital signs, vital statusa | X | X | X | |
Quality of life questionnaire | X | X | X | |
Laboratory resultsa | X | X | X | |
Serious adverse events | X | X |