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All patients gave written informed consent on entering the study, which was approved by the research ethics committee of Second University of Naples, Italy, and the study was conducted according to the Declaration of Helsinki.
All respondents signed informed consent on entering the study.
On entering the study, only two patients had received any previous anti-tumour therapy.
A tender joint count and a swollen joint count [ 8, 9] were performed on entering the study and yearly thereafter.
However, the mean time on ART on entering the study was greater in the control group (Table 1).
Haemodynamic parameters were determined by arterial thermodilution (PiCCO) on entering the study, then during the optimal PEEP defining process every 8 min, and 30 and 60 min after.
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Data were included from double-blind phases of each core study, from randomization until the first change in treatment regimen (either to rescue therapy with tocilizumab or on entering the extension studies, including the open-label LITHE extension) or until 2 years of treatment.
Second, four patients in the control group already had growth of Lp 299v on rectal biopsies when entering the study.
Bacterial culture and antimicrobial sensitivity analysis was obtained in nine dogs; the remaining dogs were already on antibacterial treatment upon entering the study.
In the four small centres, 137 patients were ineligible to enter the study on the basis of exclusion criteria.
No other restrictions applied to the patients entering the study on the basis of sex, age, histology of the tumor, or previous treatments.
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