Name | Label | Folder | |
---|---|---|---|
arm
Treatment Arm
|
Treatment Arm
The randomization code assigned by the Data Management System (DMS). |
Administrative/Randomization | |
ran1
Has the participant met all eligibility criteria and signed the consent form; and has the principle investigator reviewed and certified the individual as being eligible?
|
Has the participant met all eligibility criteria and signed the consent form; and has the principle investigator reviewed and certified the individual as being eligible? | Administrative/Randomization | |
ran2
Has the participant had an ear, nose, and throat (ENT) evaluation within 90 days of baseline, and is considered a candidate for surgery?
|
Has the participant had an ear, nose, and throat (ENT) evaluation within 90 days of baseline, and is considered a candidate for surgery? | Administrative/Randomization | |
ran3
Has the participant had an overnight Polysomnography (PSG) evaluation, and is within the protocol defined limits?
|
Has the participant had an overnight Polysomnography (PSG) evaluation, and is within the protocol defined limits? | Administrative/Randomization | |
ran4
Was the child able to perform the neurocognitive testing?
|
Was the child able to perform the neurocognitive testing? | Administrative/Randomization | |
ran5
Date the parent signed the consent form
|
Date the parent signed the consent form | Administrative/Randomization | |
ran6
Date of randomization
|
Date of randomization
The original date has been removed as part of deidentification. |
Administrative/Randomization | |
ran7
Randomization Code assigned by Data Management System (DMS)
|
Randomization Code assigned by Data Management System (DMS) | Administrative/Randomization |