Answer:
Phase III
Explanation:
The given condition fall in the trial phase (Phase III) of cinical study which aims to:
- Determine drug's effectiveness (primary goal)
- Determine long-term drug safety
- Confirm findings
In Phase III, randomised, double-blind, placebo-controlled, parallel group study is majorly to evaluate the efficacy and safety of placebo in episodic migraine prevention in children (6 to < 12 years of age) and adolescents (12 to < 18 years of age).
The trial consists of four phases: screening; double-blind therapy period for 24 weeks in which placebo or Erenumab is given to subject as dose 1, dose 2 or dose 3 (based on the participant's body weight) once a month via subcutaneous injection; optional dose level blinded extension phase (40 weeks) which involves subjects recieve dose1, 2 and 3 of placebo, and at last it follows a safety follow-up phase for 12 weeks (after 16 weeks of the last dose of investigational drug).
Hence, the clinical phase is phase III.
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Because it can cause some very bad cramps in the stomach
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