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The median time to a musculoskeletal event was shorter in the GM arm (77 days) compared with the GP arm (139 days) (P=0.053, log-rank test).
In this study the median survival time for the GM arm was 165.5 days and 164 days in the GP arm.
Compliance and tolerance of therapy was good with patients receiving a median of 106 days (range 0 654 days) treatment with marimastat in the GM arm and 85 days (range 0 619 days) treatment with placebo in the GP arm.
Analysis of progression-free survival however, revealed no difference between the GM arm (92.5 days) and the GP arm (96 days) (P=0.68, HR 0.95, 95% CI 0.73 1.23).
There was no significant difference in response rates between the two treatment arms (Table 2-wrap>), however, there was a trend in favour of placebo in the duration of response with a median of 118 days in the GM arm (n=14) and 258 days (n=15) in the GP arm (P=0.07 log-rank test).
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To link the Trap genomic fragment with the Dmp1/ Ibsp genomic fragment we cloned three homology arms, each ~1 kb in size into BACLink-SP (Arms 1, 2, & 3) and two homology arms were cloned into BACLink-GM (Arms 3 & 4).
Recent reports have described that the GM-CSF/Jak2/STAT5 arm of signaling is essential to determine the DC differentiation from progenitor cells.
The index of multiple deprivation score 14 for each family showed a median value of 19 (IQR: 10, 31) for families in the GM-CSF arm compared with 19 (IQR: 10, 34) in the control arm.
We found no significant differences in cognitive, general health or educational outcomes between 83 of 106 (78%) surviving children in the GM-CSF arm compared with 81 of 110 (74%) in the control arm.
In the GM-CSF arm, 83 children were evaluated at a median of 65 months (range 50 78) and 81 in the control arm at a median of 65 months (52 78).
In the GM-CSF arm, 87 of 134 (65%) babies survived to 2 years without severe disability compared with 87 of 131 (66%) controls (RR: 1·0, 95% CI 0·8 to 1·2).
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