Data availability
SECONDARY
We intend to make data collected for the study, including anonymized individual participant data and a data dictionary defining each field in the set, available to others. Related documents will be available, including the trial protocol and the statistical analysis plan. These data will be available with the publication of our main manuscript and all secondary projects as outlined in our trial protocol on receipt of a letter of intention detailing the study hypothesis and statistical analysis plan. The steering committee of this trial will discuss all requests and decide on the basis of the scientific rigor of the proposal whether data sharing is appropriate. All applicants are asked to sign a data access agreement. Please send any request to the principal investigator of this trial.