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. 2021 Feb 19;22:155. doi: 10.1186/s13063-021-05083-1

Table 1.

Study visits and measurements

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