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Under this mutual recognition process, authorities in other concerned member states have 55 days to raise objections, which must then be resolved by discussion among the concerned member states, the reference member state and the applicant within 90 days of the commencement of the mutual recognition procedure
The dose-escalation schedule used in clinical trials starts at a low dose (typically 3 mg) and gradually increases over approximately 12-16 weeks to the target maintenance dose
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