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This collagen/chondroitin sulphate/calcium phosphate scaffold was demonstrated to induce healing with a repair tissue with features of hyaline cartilage at a 6 month end point in the caprine knee [4].
The other subjects were lost to follow-up before the 6 month end point.
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The rationale for a 3-month end point is that the majority of smoking relapses occur within the first 3 months post-release (Ockene et al., 2000).
Pharmacokinetic measures included total daily dose (TDD) of study drugs and tacrolimus trough levels.24-month treatment failure was LCPT, 23.1%; IR-Tac, 27.3% (treatment difference, -4.14% [95% CI, -11.38% to +3.17%], well below the +10% noninferiority criterion defined for the primary 12-month end point).
The two study pathologists reviewed all biopsies obtained at the 6-month end point.
A small increase was observed at the 6-month end point (Table 4).
Change in CGAS scores at the 6-month end point also showed that all groups experienced functional improvement relative to open-label baseline (Table 2).
Mean score changes from open-label baseline to the 6-month end point indicated improvements in all five PANSS factor scores (Table 2).
Mean body weight, height, and BMI increased similarly in all groups from open-label baseline to 6-month end point (Table 4).
We defined persistent CIN 3 lesions as those that did not regress from the time of the initial biopsy to the 6-month end point.
We defined HPV resolution as those with a presence of HPV DNA at initial entry and subsequently had undetectable levels of any HPV DNA at the 6-month end point.
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