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. 2017 Oct 4;11(10):e0005952. doi: 10.1371/journal.pntd.0005952

Table 1. Overview of primary and secondary outcomes.

Outcome Definitions
Primary outcome Proportion of patients with restored or improved nerve function Using a composite score.
Restored: all nerves back to normal function
Improved: more restored* and/or improved** nerves than unchanged and/or deteriorated*** nerves
Unchanged: same number of nerves impaired
Deteriorated: more deteriorated nerves than improved and/or restored nerves
Secondary outcomes 1. Proportion of restored, improved, unchanged, deteriorated and fully impaired nerves for each specific nerve–e.g. ulnar nerve For six sensory nerves and seven motor nerves
2. Count of impairments Per patient 26 nerves were assessed. Each impaired nerve adds 1 point to the total score
3. Improvement Reaction Severity Scale Improvement: reduction in RSS of 3 or more points on the total score, or a reduction of 2 or more points on any individual item of the scale
4. Improvement in SALSA-scale and P-scale Improvement: classified in a better category (extreme, severe, moderate, mild, none)
5. Proportion of patients with Serious Adverse Events
6. Proportion of patients needing additional steroids for treatment of reaction or worsening NFI

* restored: back to normal function

** improved: decrease of 3 points for MFT or increase of 1 point for VMT

***: deteriorated: increase of 3 points for MFT or decrease 1 point for VMT