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Adjuvant 5-FU-based chemotherapy had to be completed >6 months before entry.
Importantly, treatments and physiotherapy schedule were not changed for 3 months before entry and all during the trial.
All controls reported no significant changes in their body weight for at least three months before entry to the study.
Patients who had received adjuvant bolus 5-FU/folinic acid were eligible provided chemotherapy had been completed more than 6 months before entry into the study.
Of three patients who had received octreotide for over 12 months before entry to the study two had stable disease following capecitabine that may have been the effect of ongoing octreotide therapy (Brizzi et al, 2009; Rinke et al, 2009).
An international, double-blind, placebo-controlled Phase III trial in patients with metastatic MTC who had radiographic progression of disease within the 14 months before entry led to the US regulatory approval of cabozantinib in this disease.
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Participation in another clinical study within 1 month before entry to this study.
Participants were categorized as active smokers if they were current smokers or had stopped smoking less than 1 month before entry into the study.
We also adjusted for age, sex, previous non-hospitalised pneumonia, and prescription of PPIs, H2RAs and NSAIDs in the 7 12 months before cohort entry (prescriptions in the 6 months before cohort entry resulted in exclusion) in our outcome model.
PSA doubling times were positive in all patients (median = 15 months) before study entry, i.e. PSA levels at study entry were higher than the initial PSA levels.
Patients were not eligible in case of digital ulcers due to other conditions than SSc, prostanoid therapy during the last month, sympathectomy of the upper limb performed within 12 months before study entry, current smoking or smoking within 4 weeks before study entry, and any other severe concurrent illness.
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