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Participants will be followed for at least 13 years from randomization to ascertain all cancers of the prostate, lung, colorectum, and ovary, as well as deaths from all causes.
Follow-up data were available for up to 6 years, from randomization through December 2006.
Using patients' data, OS and RFS were estimated by the Kaplan-Meier method, up to 5 years from randomization.
The extended posttrial follow-up in the HDS study had a median duration of 8 years for a total follow-up duration of 14.5 years from randomization.
In the Langer trial patients were evaluated three and six months after the end of treatment and then every six months until five years from randomization [ 17].
Though not statistically significant an inverse trend in OS was seen for patients with RRM1 aberrations 0-1.5 years from randomization.
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For cases occurring after the first year from randomization, the 1-year plasma specimens were plated with baseline specimens for concurrent ELISA analyses.
Falls diaries with daily entries will be used to record falls occurrences, and will be returned monthly for one year from randomization, as recommended by previous studies [ 7].
Subsequent analyses exclude 31 breast cancer cases in the CEE + MPA trial and 16 cases in the CEE trial that occurred during the first year from randomization.
All subjects in this substudy were adherent to study medication (defined as taking >80% of study medication per protocol) throughout the first year from randomization.
Elevated concentrations at 1 year from randomization compared to baseline were observed in these independent samples for all ten proteins studied.
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