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Description

The side effect profile at the 12mg dose includes nausea (28% of participants), diarrhea (23%), constipation (17%), and vomiting (12%)

Alongside product development, the company is investing in market groundwork

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"Further, while we acknowledge the corrective and preventive actions that your site has taken or plans to take, your written response is inadequate because it does not provide sufficient details about how you, as a clinical investigator, will ensure adequate oversight of the study procedures (for example, adherence to eligibility requirements)