A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
3 participants were withdrawn due to noncompliance
1 participant withdrew consent after experiencing severe nausea
1 participant had to discontinue IP for an unscheduled hospitalization
1 participant who is not returning for visits
2 participants completed the 6 months of treatment
4 participants currently on IP
How many participants should be replaced?
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