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Clinically relevant deterioration after PCI relative to the baseline was found in 12.3% up to 1-month follow-up.
No substantial imbalance at baseline was found in the primary end-point variables between the arms (Table 3).
In the laboratory tests, no consistent change from baseline was found in mean values of LFT parameters in any cohort (data not shown).
Skin petechial hemorrhage (not observed at baseline) was found in one subject in the F17 group (2.5%) and was not found in the other two groups.
After 78 weeks reduction by 50% or more in RF titre with respect to baseline was found in 15 patients, whereas such a reduction in anti-CCP antibody titre was noted only in two patients.
A trend toward a higher mean (range) Larsen score at baseline was found in the SINGLE group compared with the FIN-RACo group: 5 (0 to 30) versus 3 (0 to 25) (P = 0.069).
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It is worth noting that no significant difference between one-year follow-up and baseline is found in any centre, with the exception of Dublin, which shows a significant increase (p = 0.002).
AKI requiring renal replacement therapy (RRT) has been reported in 5% of all patients after CS; 8% to 15% present with increased serum creatinine of >1.0 mg/dl; and a discrete increase in creatinine of 25% from baseline is found in 50% [ 4].
AKI requiring renal replacement therapy (RRT) has been reported in 5% of patients after cardiac surgery; 8 to 15% present increased serum creatinine of >1.0 mg/dl; and a discrete increase of creatinine of 25% relative to the baseline is found in 50% of patients [ 4].
An interaction between treatment category and a history of stroke or TIA at baseline was found: those in the placebo group with a previous event had an atrophy rate per year of 1.76%[1.31 2.21] compared with 1.01% [0.86 1.15] for those without an event.
Similarly, a higher prevalence of parental atopy (e.g. allergic rhinitis) at baseline was found for participants in the questionnaire part (22%) and those participating in the clinical part of the study (27%) compared to non-participants (11%).
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