NCT03898713 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Levelt WJ
Models of word production. Trends Cogn Sci. 1999 Jun;3(6):223-232.
Robin NH, Baty H, Franklin J, Guyton FC, Mann J, Woolley AL, Waite PD, Grant J
The multidisciplinary evaluation and management of cleft lip and palate. South Med J. 2006 Oct;99(10):1111-20. Review.
Waitzman NJ, Romano PS, Scheffler RM
Estimates of the economic costs of birth defects. Inquiry. 1994 Summer;31(2):188-205.

Assessment of Intellectual Abilities for Subjects With Velopharyngeal Incompetence and Their Impact on Speech Intelligibility

Clinical trial NCT03898713 - References