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*later protocol amendment eliminated these sample collections.
Recruitment was therefore suspended pending a major protocol amendment.
There was one protocol amendment before recruitment started.
Ethics approval was obtained for the protocol amendment.
After a protocol amendment, some patients with treatment failure of adalimumab also entered the study.
In our study, 14 out of the 27 patients were included after the protocol amendment.
A protocol amendment was made to dose escalate from 200 to 800 mg.
Of note, the 10 mg/m dose level was added as a protocol amendment.
The EQ-5D generic quality of life instrument was included within this study by protocol amendment.
The motivation study was added as a protocol amendment to the main Diagest 3 study.
A mid-trial protocol amendment increased the target sample size to 4000.
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