Table 1.
Study visits | ||||||||
---|---|---|---|---|---|---|---|---|
Intervention period (in weeks) | Follow-up period (in weeks) | Safety follow-up (in weeks) | Unscheduled visits (in weeks) | |||||
Measurements | BL | 6 | 12 | 18 | 24 | 52 | 104 | 0–52 |
Blood pressure | X | X | X | X | X | X | X* | |
Body weight | X | X | X | X* | ||||
HbA1C | X | X | X | |||||
AEs | X | X | X | X | X | X‡ | ||
AE questionnaire§ | X | X | X | X*¥ | ||||
I-RODS | X | X | X | X | X | X | X | X |
INCAT-DS | X | X | X | X | X | X | X | X |
Grip strength | X | X | X | X | X | X | X | |
MRC sum score | X | X | X | X | X | X | X | |
INCAT-SS | X | X | X | X | X* | |||
EuroQol | X | X | X | X | X* | |||
iMCQ | X | X | X | X* | ||||
iPCQ | X | X | X | X* | ||||
R-FSS | X | X | X | X | X* | |||
PI-NRS | X | X | X | X | X* |
Abbreviations: BL baseline, AE adverse event, I-RODS inflammatory Rasch Disability Scale, MRC Medical Research Council, INCAT-DS Inflammatory Neuropathy Cause and Treatment Disability Scale, INCAT-SS Inflammatory Neuropathy Cause and Treatment sensory sum score, iMCQ iMTA Medical Consumption Questionnaire, iPCQ iMTA Productivity Cost Questionnaire, R-FSS Rasch-built Fatigue Severity Scale, PI-NRS pain intensity numeric rating scale. *If the unscheduled visit is considered as a preliminary endpoint visit. §This row includes the investigator assessed (long-term) AEs investigated at weeks 52 and 104. ‡If unscheduled visits takes place during treatment protocol, within 6 weeks of ending treatment protocol. ¥In case of a preliminary endpoint during intervention period, week 18 AE questionnaire is completed by patient and physician