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Documented time of death was obtained for all patients but 5 who were lost to follow-up and had no information after sampling visit.
Recurrence-free survival was recorded from sampling visit and censored at the time of the last control cystoscopy.
Cancer-specific survival was recorded from sampling visit and until the last annotation of the patient being alive.
We performed analysis of variance (ANOVA) of the log10 transformed rSBA titres at each blood sampling visit and present results as geometric mean titres with 95% confidence intervals.
Progression-free survival time was recorded from sampling visit and censored at the time of the last control cystoscopy or at cystectomy.
A new intramammary infection (NIMI) was defined when a quarter had milk SCC <200,000 cells/mL for multiparous cows and <100,000 cells/mL for primiparous without microorganism isolation, and in a subsequent sampling visit had milk SCC >200,000 cells/mL for multiparous cows and >100,000 cells/mL for primiparous cows, and positive microorganism isolation.
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Genotype data for live animals were provided to Signet by the NSP Administration Centre following blood sampling visits to each farm.
Data were then abstracted from the medical record for each sampled visit [ 10].
For each sampled visit, patient demographics, the time spent with the physician, and the diagnostic, preventive and therapeutic services provided during the visit are collected.
The Per Protocol (PP) immunogenicity analysis population included all participants, who received the three doses of the allocated product in the allowed intervals and timely attended all the scheduled blood sampling visits.
There was no significant difference (p <0.05) in blood-Hg levels observed among the three sampling visits.
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