Zeeshan Sheikh • over 5 years ago
Other Inclusion criteria
I noticed that because the eligibility section is free text with a format recommendation (rather than a specific call out to inclusion and exclusion); this (example) study has an additional inclusion.
1. Can/Should we ignore the additional Inclusion criteria (that is applied at randomization for maint phase); OR
2. Should we group it in with the inclusion criteria; OR
3. Should we add it in addition to the inclusion/exclusion sections that are required?
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