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Fatigue and school attendance were the main outcomes and the main time point for assessing outcome was 6 months post-treatment.
The main time point for analysis of the main trial was 12 weeks.
Main time point for the analysis of the QoL outcome was at 18 weeks, and assessment at 26 weeks was considered important for confirmatory analyses.
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Gravid mice were assessed at 7.5 and 12.5 dpc, two main time points that represent placental angiogenesis and establishment of the fetomaternal circulation, respectively.
The main time points in the analysis were baseline, 52 weeks (end of combination therapy), 78 weeks (6 months after the end of combination therapy), and 130 weeks (end of followup).
Additional exclusive analysis was performed only for the two main time points (days 7 and 28) because this period is the most interesting for the study, as it reflects the changes at study termination.
The main time-points for postbaseline efficacy evaluations were weeks 4, 8 and 12.
All participants were assessed on two self-report outcome measures at two main time-points during the study: pre-intervention (baseline) and post-intervention.
The inverted main contrast (time point 3 minus time point 1) was assessed for the sake of completeness (no significant results).
Of the 119 women allocated to Mirena, 24 (20%) had undergone hysterectomy before the main analysis time point at 12 months, with a further 13 (11%) no longer using the Mirena.
c) HRSD-remission rates (HRSD ≤ 8) and HRSD-response rates (HRS Dscore by at least 50percentt from baseline) will be calculated for the main measurement time points.
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