Pharmacologic treatment with standard behavioral treatment

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A research study will compare a new combined behavioral and pharmacologic treatment with the standard behavioral treatment alone for individuals with severe seasonal affected disorder (SAD). The researcher wants to include pregnant women in the study. However, the pharmacologic treatment has not been previously studied in non-pregnant women, nor have preclinical studies on pregnant animals been conducted. Is this research permitted under Subpart B?

Reference no: EM133560209

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