Table 1.

Reasons for primary outcome events

Code	Name	Definition	Field test
1	Type 1 reaction	Skin signs of severe type 1 reaction needing prednisolone, but without nerve function impairment	Skin examination; <2 levels of change in voluntary muscle test and <3 levels of change in sensory test; no severe nerve tenderness
2	Type 2 reaction	Skin signs of severe type 2 reaction needing prednisolone, but without nerve function impairment	Skin examination; <2 levels of change in voluntary muscle test and <3 levels of change in sensory test; no severe nerve tenderness
3	Facial lesion	Reactional lesion over a facial nerve, without nerve function impairment	Skin examination; <2 levels of change in voluntary muscle test and <3 levels of change in sensory test; no severe nerve tenderness
4	Nerve tenderness	Severe nerve tenderness in any tested nerve	Gentle nerve palpation; patient shows signs of distress
5	Motor function impairment	New motor function impairment in any tested muscle	Reduction in MRC score of 2 points from baseline at trial entry
6	Neuritis	New partial motor or sensory loss and partial tenderness in the same nerve	Reduction in MRC score of 1 point or change in monofilament test of 1 or 2 levels, plus mild tenderness in the same nerve
7	Median sensory nerve function impairment	New sensory loss in the median nerve by monofilament	Change in sensory function as measured by monofilament of 3 levels from baseline at trial entry
8	Ulnar or posterior tibial sensory impairment	New sensory loss by monofilament in the ulnar or posterior tibial nerve	Change in sensory function as measured by monofilament of 3 levels from baseline at trial entry

MRC=Medical Research Council.