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Based on the process performance, weeks 1 6 are defined as the start-up period, and weeks 7 12 are defined as the steady state period.
Regarding short-term in-hospital stays, patients were not allowed to receive short-term stays within 3 weeks of every efficacy evaluation (i.e., at the start of the double-blind period and weeks 4, 12 and 24) in the Phase II study.
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AEs reported at week 16 (fixed treatment regimen study period) and week 24 are summarised in table 3.
Safety findings are provided through week 16 (placebo-controlled period) and week 24 in table 4 and through week 60 in online supplementary table S4.
All patients again had a 2-week washout period and 2 weeks of treatment double blinded.
The participants trained for ~8 weeks (25.0 ± 10.3 h per week) in the pre-season period and ~38 weeks during the competitive season (10.0 ± 7.4 h per week).
Clinic visits took place at baseline (on completion of the 2-week run-in period), and at weeks 4, 8, and 12 of the treatment period.
The study will be conducted in approximately 134 post-CR participants over a period of 16 weeks comprising of a 12 week intervention period and 4 week follow up assessment.
Health and social care utilisation and health-related quality of life (EQ-5D) were assessed over the 20 weeks of the study (ten-week intervention period and ten-week follow up period), and these data were complete for 93 participants.
Baseline assessments were made following a two-week washout period and 1 week before the trial began, while the child was not on any medication.
We will also record the falls over the study period and 1 week after.
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