Limitations
NDI
SECONDARY
This was a secondary analysis of an RCT, thus, the sample-size calculation was based on the main outcome NDI in the RCT. Next, the loss of follow-up (21% at 1 year and 30% at 2 years) was regarded as acceptable given that the follow-up was based on a clinical examination and that some patients had long way to travel to attend follow-up. Moreover, there was no difference at baseline between the patients who were included in the analysis and the patients lost to follow-up, suggesting no impact of loss to follow-upon the results. Patients had about 80% good global outcome, which is comparable with earlier studies