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The main reason for treatment discontinuation in both study arms was disease progression (61.9% for EVE+EXE vs 88.7% for PBO+EXE).
In our study, the surgical difference between both study arms was perceived by women to be minimal hence was not shown to significantly influence women's decision-making.
The QoL of the patient in both study arms was analyzed using specific questionnaires (EORTC QLQ-30, EQ-5D, and EQ-5D VAS) that overall quantified health-related aspect.
Additionally, the ORR in both study arms was higher than in the V325 study (48.7 % in the mDCF regimen arm vs 30.3 % in the DCF arm; 33.9 % vs. 19.9 % in the CF arm).
Although supplemental hydroxyethyl starch use in both study arms was partially 'goal-directed' - on the basis of cardiac output responses assessed by esophageal Doppler - the doses used for fluid loading were relatively fixed rather than completely based on cardiac fluid responses (fluid responsiveness).
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The image sets from both study arms were used to make clinical outcome assessments between baseline and four months.
Demographic and clinical characteristics obtained on patients from both study arms were analyzed to point out an association with the response to the treatment.
Demographic (sex, age), clinical (body mass index, comorbidity, surgery) and headache characteristics (frequency, intensity, total and MOH duration, overused drugs) in Responders and Non-Responders (R and NR, respectively) from both study arms were compared.
A flow chart of the animals in both study arms is presented in Figs. 2 and 3. Fig. 2 Flow chart of animals in the sepsis groups Fig. 3 Flow chart of animals in the hemorrhage groups.
No carry over effects were detected and data from both study arms are combined.
Exacerbations in both study arms are defined using the Anthonisen symptom diary-card algorithm.
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