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The maintenance phase has been uneventful.
Low-dose fotemustine at 65 75 mg/m2 (induction phase) followed by 75 85 mg/m2 (maintenance phase) has an activity comparable to that of the conventional schedule.
Finally, the optimal duration of the maintenance phase has not been studied adequately since few studies reported follow-up periods longer than 1 year.
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In contrast, CARB treatment during the maintenance phase had no effect on the established thermal hyperalgesia and mechanical allodynia nor on spinal GFAP expression or the number of pNR1-ir cell profiles.
This assumption will likely cause the placebo maintenance response to be underestimated, since some of the 230 patients that switched to golimumab 100 mg could have later achieved response during the maintenance phase had they continued on placebo.
At study entry, the treatment groups were similar with respect to demographic and clinical characteristics, although slightly more patients receiving placebo during the maintenance phase had received esomeprazole 20 mg than either esomeprazole 40 mg or placebo during the acute phase (Table 1).
One of the main reasons is that the technical barriers, which span from design phase through to commissioning and maintenance phases, have not been understood by stakeholders.
Sixty-three (22.9%) of 275 participants, titrated to either 50 mg/d (n=108) or 70 mg/d (n=167) LDX at the start of the dose-maintenance phase had a dose decrease; 113 participants had either an increase or a decrease from their titrated dose.
The follow-up for all patients ends 4 years after the last active patient in the maintenance treatment phase has received the first dose of the maintenance therapy (i.e. had had two such follow-up assessments).
The 6-month follow-up in our pilot study allows for a 12-week maintenance phase that has become standard for confirmatory trials.
Among the 12 HU under the treatment, 9 were in the detoxification phase (entering the program within one week before the scanning, mean = 2.1 days, SD = 1.8), while the remaining 3 were in a relatively stable maintenance phase (one had been in the program for 2 months and the other two for 6 months).
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