Endpoints
pain
Every evening, just before administering the study drug, the patients evaluated their pain at rest and during movement over the previous 24-h period using a 100-mm VAS. This information was used to determine the primary endpoint—the change in the VAS for pain at rest from baseline (averaged over the 3 days before starting treatment) to the end of treatment (EOT; averaged over study days 12–14) or at discontinuation (averaged over the 3 days before discontinuation). A clinically relevant change in the VAS for pain was defined as a moderate or greater improvement during treatment relative to the baseline score using the chart shown in Supplementary Table 