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As summarised in Table 1, other significant covariates predicting higher on-treatment EQ-5D VAS scores included high EQ-5D VAS at baseline, patient placement in the MSKCC intermediate-risk group, with no prior nephrectomy, and patient assessment at week 12 compared with those assessed at their withdrawal visit.
Statistically significant reductions in headache day frequency were observed from the first assessment at week 24 (headache day frequency reduced by 7.4 days from baseline; P < 0.0001) and at all subsequent assessment points including week 60 (Fig. 4a).
After the treatment assessment at week 18, patients will receive the ARG-Vx001 or placebo every 12 weeks starting from week 27 until disease progression, unacceptable toxicity, withdrawal of informed consent, or death.
In vitro and in vivo; Mouse musculo-tendinous junction model Hashimoto et al. 2016 Human ACL-derived CD34+ cell sheet ACL-derived CD34+ cell sheet improved the ACL repair which was judged by histological assessment at week 2 and biomechanical evaluation at week 8 in a rat ACL injury model.
Patients failing to reach assessment at week 8 were deemed not evaluable and classified as PD.
All patients underwent a final efficacy and safety assessment at week 22.
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The expected follow-up of each participant is 26 weeks with follow-up assessment at 6 week, 12 week and 26 week post-start of treatment.
A set of seven blood samples was gathered at 30-min intervals for GH assessment at weeks 12 and 28, the last sample was taken just prior to lanreotide Autogel injection.
The trial will be a multicentre three arm individually randomised controlled trial with independent assessment at 6 week, 12 week and 26 week post-randomisation.
Follow-up was continued for total of six months, with assessment at one week, four weeks, 12 weeks and six months.
Outcome assessments at week 12, week 24 and week 36 will test the immediate, intermediate and long-term effects of exercise-based MI on adherence (as measured by the Community Health Activities Model Program for Seniors/CHAMPS and accelerometer) and clinical outcomes.
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