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The following groups were defined for the analyses: 1) Children with a constant status of GJH, meaning that the child had a BT score of ≥5/9 on both tests rounds (n = 36).
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Two other populations were defined for the sensitive analyses: one taking into consideration all "randomized" manuscripts and one including only those manuscripts accepted for publication.
Three main groups of subjects are defined for the primary analyses: Group 1: Subjects who develop preeclampsia/eclampsia/HELLP syndrome within the first week after the baseline visit.
The 30-year cumulative incidence of microalbuminuria, defined for the observational analyses as sustained AER ≥30 mg/24 h to be consistent with recent guidelines (18, 19), was 25 or 38% among participants assigned to INT or CON, respectively (Fig. 3) (15).
Retinopathy, assessed during EDIC years 11 14 by 7-field stereoscopic fundus photography according to the DCCT/EDIC protocol (26), was defined for these analyses as the presence of proliferative diabetic retinopathy (PDR) or worse, and/or a history of panretinal scatter-photocoagulation (laser) therapy.
Discordant cases have been discussed in common and a consensus was defined for the subsequent statistical analyses.
A Per-Protocol (PP) population will also be defined for the non-inferiority analyses, which will exclude participants who violate the protocol or fail to comply with the required treatment regime.
An additional level for the factor "stimulation site" was defined for the statistical group analyses whenever an anatomical region included individual stimulation sites: The first level representing a particular region was based solely on the TMS data gathered at the fMRI group site (indicated by the subscript "group" in the following).
The TEMPO trial [ 30, 31] did not meet the inclusion criteria defined for the network meta-analyses; the study population was not comprised solely of patients diagnosed with RA showing an inadequate response to MTX.
To determine whether the measurement model was appropriate for both younger and older children, the model previously defined for the overall sample was analysed in two parallel groups: children up to age 6 and children older than 6 years of age.
Two different models were defined for the results obtained from these analyses.
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