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Prospective recruitment is important to ensure adequate and accurate collection of baseline variables and more complete follow-up.
Mean treatment session duration was 30 minutes, mean total of treatment sessions After collection of baseline variables before surgery and at hospital discharge, outcome measures were assessed at 17 days, six weeks and three months after surgery, during normal routine assessments at the orthopaedic clinic (Table 1) or by visiting the patients at home.
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Studies indicate that WHF cannot be precisely predicted on the basis of baseline variables assessed at the time of admission.
Measurements of baseline variables were described previously.
The analysis variables consisted of baseline variables, safety variables, efficacy data, and laboratory data.
Distribution of baseline variables was assessed using the Kolmogorov-Smirnov test.
Means ± SD describe the distribution of baseline variables.
Effects of baseline variables were explored in the final analysis.
The analysis variables consisted of baselines variables, primary endpoints (safety variables), and secondary endpoints (immunogenicity variables).
Following the collection of baseline and outcome variables, the intervention (LWHP) is applied to all subjects.
The open-label design is theoretically more prone to bias; however, we use a remote automatic randomisation system after collection of baseline data, hard outcomes as secondary variables and external evaluation by blinded investigators.
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