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Both WT-HH and WT-LL mice showed an initial escalation in drinking (time effect: F[6,78] = 27.1, p < 0.001; week 7 v. week 1: WT-HH and WT-LL p < 0.001).
Following an initial escalation strategy mimicking the standard design, we have the following observations on nine patients; level 1: 0 toxicities/three patients level 2: 0 toxicities/three patients level 3: 2 toxicities and one non-toxicity/three patients.
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The initial dose escalation safety portion of the study (Part 1) will include higher risk patients and limit the unrelated donor transplants.
It is common to see DEC involving several hundred patients, building on an initial dose escalation study that may have no > 20 to 30 patients.
The initial dose escalation phase of the study consisted of four cohorts.
Thirty-six of 37 patients received an initial dose escalation dose of 40 mg of octreotide LAR (97%).
Of 13 patients with diarrhea, 8 (62%) reported a significant decrease in their symptoms after initial dose escalation.
Ten (91%) of the 11 who had flushing reported a marked decrease in their symptoms upon initial dose escalation.
There was a significant relationship between recovery platelet levels and increasing doses of E. coli RNA fragments at the baseline or initial dose escalation of RNA fragments.
The dose response relationships with E. coli RNA fragments chemotherapy induced platelet nadir levels were evaluated at baseline or the initial dose escalation of RNA fragments.
An initial dose-escalation study was performed to determine the optimal dose of rapamycin in FaDu xenograft-bearing BALB/c mice.
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