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Article summary:
1. A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial was conducted in China to assess the efficacy and safety of ansofaxine (LY03005) for major depressive disorder.
2. 588 MDD patients were included and randomly assigned to 8-week treatment with ansofaxine 80 mg/day, ansofaxine 160 mg/day or placebo.
3. Results showed that both doses of ansofaxine were effective and safe in the treatment of adult MDD patients.
Article analysis:
The article is generally reliable as it provides a detailed description of the study design and results, including information about the participants, primary endpoint, safety measures taken, and adverse events reported. The article also includes a ClinicalTrials.gov identifier which allows readers to access additional information about the study if needed.
However, there are some potential biases that should be noted. First, the study was conducted in China which may limit its generalizability to other populations due to differences in culture and healthcare systems. Second, the sample size was relatively small (n=588) which could lead to inaccurate results due to lack of statistical power. Third, there is no mention of any potential conflicts of interest or funding sources which could influence the results or interpretation of data presented in the article. Finally, there is no discussion of any long-term effects or implications from taking ansofaxine for major depressive disorder which could be important for clinicians when considering prescribing this medication for their patients.