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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.
Administration of postoperative radiation therapy is registered and the percentage difference between both study arms is recorded.
However, the applied chemotherapy in both study arms is documented accurately and will be included as a covariate in the multivariate analysis.
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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.
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.
Demographic details of the sample for both study arms are provided in Table 1.
The most common adverse events observed in both study arms were: abnormal dreams/nightmares, dizziness, fatigue, somnolence, diarrhea, and headache.
Women in both study arms were invited for screening using a similar letter with general information on screening.
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.
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