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It granted early termination of the waiting period under the Hart-Scott-Rodino Act, more than a week ahead of before the 7 November deadline

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The drug increases serotonin levels by preventing its reabsorption, and over time, the body might adapt, creating dependency to maintain a balanced mood and emotional stability

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So while the raw numbers show headaches in trial participants, the signal was not strong enough relative to placebo to warrant special labeling

doi: 10.1001/jamanetworkopen.2024.57349 .