Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
SECONDARY
The primary and secondary endpoints can only be examined if the patients are able to conduct the tests. Patients who are not able to conduct the tests and patients who died before the assessment will be excluded from the full analysis set.Other scenarios for not conducting a follow-up are the following: unattainability of a patient, absence at the follow-up appointment, or the parents do not want to attend the follow-up examination. For these scenarios, missing values might not be related to the outcome and be comparable to the observed values in the intervention and control groups, and these scenarios assume that values are missing at random or missing completely at random. Thus, a multiple imputation for the endpoints will be done.No other imputations of missing data will be performed, and all other analyses will be based on complete cases.