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An informed written consent form will be signed by a parent or legal guardian (and patients ≥16 years) before the study enrolment.
Psychosis: During the 8 weeks before the study enrolment (visit 2, V2), there has been no evidence of psychosis that is defined in the PPQ; the answers to questions B (hallucinations/illusions) and C (delusions) are none (score 0) at V1 and V2.
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In case of participant J, the dates when OPV doses were given were unavailable, but the age (4 months), recent admission to the orphanage, the mention of having received 3 OPV doses in medical record, and the pattern of shedding suggest that this child likely had received one or more doses of OPV immediately before or during the study enrolment period.
The institutional review boards of the National Public Health Institute in Finland and the US National Cancer Institute approved the study protocol, and written informed consent was obtained from the participants before study enrolment.
Concerning the comparison with the method used in the 3 months before study enrolment, 78.1% of subjects had a preference/strong preference for the patch due to convenience, ease of use/simplicity and fewer side effects of the patch over the other methods; similarly, Weisberg reported that almost 3 out of 4 participants preferred the patch to their previous method [ 36].
We grouped adults with CF according to their exacerbation status in the year before study enrolment: (1) <1 exacerbation/year; (2) 1–2 exacerbations/year; and (3) >2 exacerbations/year.
Each of the nine patients with chronic uveitis and with an AU flare during adalimumab treatment had experienced uveitis flares within the year before study enrolment.
If women of child-bearing age participate in the EPATH study, pregnancy will be ruled out at the beginning of the active participation before study enrolment.
However, individuals reporting any lower gastrointestinal procedure (proctoscopy, sigmoidoscopy, barium enema, or colonoscopy) during the 3 years before study enrolment were excluded from the trial.
Patients under B vitamin supplementation and/or using drugs interfering with one-carbon metabolism in the 3 months before study enrolment were also excluded.
Participants were classified as current, former or never smokers 1 year before study enrolment based on the self-reported information collected in the WABOHS.
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