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The 89 patients comprising the ITT population were randomised to receive chemoradiotherapy (n=43) or radiotherapy alone (n=46).
Around 200,000 women from the general population were randomised to either screening with transvaginal ultrasound (TVS) or multimodal screening with CA125 and TVS or no screening.
We defined a real world at risk population through primary care, and 87.3% of the eligible population were randomised and participated.
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The population was randomised to begin with one of the six sequences.
The population was randomised by JWAS and JJH using computer aided block randomization at household level, utilizing Random Allocation Software to assign treatment groups.
A total of 242 patients – representing a real-life population - were randomised between February 2010 and January 2011 and received at least one dose of the study medication.
Of the patients in the pooled population who were randomised and dosed, 85.9% and 85.4% of those <65 and ≥65 years of age, respectively, completed the 26-week treatment period.
A total of 120 geographical clusters covering an estimated population of 121,531 were randomised to two trial arms: 60 clusters in the intervention arm receive home visits, group meetings, and support to Village Health Sanitation and Nutrition Committees; 60 clusters in the control arm receive support to Committees only.
The radiographic analyses were performed on a modified intent-to-treat population at year 2. The modified intent-to-treat population included patients who were randomised and treated, completed the 1-year double-blind period, and continued to receive at least one dose of study medication during the open-label period.
After baseline assessments (n = 3533, 53% of invited population), primary care practices were randomised to standard care or intensive vascular care.
The primary efficacy analysis was performed on data from the modified intent-to-treat population (all patients who were randomised and received one or more doses of study drug).
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