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Proof is to be submitted via blinded surgical reports and signature verifying that data are correct and interventions have been performed as a main surgeon.
All patients with a baseline pathogen and an investigator-assigned outcome of failure, and those with an outcome of clinical cure who underwent a second procedure, were reviewed by an independent blinded surgical review panel comprising 3 surgeons and 2 radiologists.
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Patients, outcome assessors, data analysts, and the Steering Committee are blinded to surgical allocation.
Statistical analysis was conducted by an independent statistician blinded to surgical outcomes.
Over the past century interventions on the pulmonary valve have undergone a remarkable evolution progressing from closed, "blind" surgical valvotomy to open surgical valvotomy and finally percutaneous balloon valvuloplasty, all with excellent procedural and long term outcomes.
The investigators who will be blinded to the surgical treatment will be responsible for identifying the complications related to the surgical procedure (e.g., the failure of tendon fixation, pain at the level of the bicipital groove, nerve injury, infection or skin scarring at the surgical site, cosmetic deformity) that might affect each subject throughout the study and follow-up period.
Therefore, to avoid potential bias, assessment of the ICRS grade by an independent observer who is blinded to the surgical technique is required for a more objective evaluation.
Patients were followed at 2, 6, 12, 24 weeks and at 1 year postoperatively by another knee surgeon who was not associated with the surgery and was blinded to the surgical procedure.
Investigators blinded to the surgical protocol of each rat performed these behavioural tests.
Data analysts and the HEALTH Steering Committee are blinded to the surgical allocation throughout the trial.
Statistical analysis was performed by an independent statistician blinded to the surgical procedures.
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