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Data were coded to ensure confidentiality and blinding to group allocation in the statistical analysis.
Owing to the blinding to group allocation, a study nurse is responsible for the main contact with the participants.
This difference in number of ports has potential for introducing bias by compromising patient blinding to group allocation.
All self reported outcome measures and procedures were pilot tested, the data collection nurses were trained and assessed for blinding to group allocation, and our losses to follow-up were below 15%.
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The study will be single-blinded such that the assessors will be blinded to group allocation.
This investigator was blinded to group allocation.
This analysis was performed by a pathologist (VLC) blinded to group allocation.
Assessment and data analysis was conducted blind to group allocation.
The experts were blinded to group allocation.
Data collectors were blind to group allocation.
Assessors will be blind to group allocation.
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