References
- Flynn, K. E., J. M. Kramer, C. B. Dombeck, et al. 2013. Participants' perspectives on safety monitoring in clinical trials. Clinical Trials (London, England) 10(4):552–9.
- Mausner, J. S., and A. K. Bahn. 1974. Epidemiology: An introductory text. Philadelphia: W.B. Saunders.
- Schulz, K. F., I. Chalmers, R. Hayes, et al. 1995. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 273(5):408–12.
- U.S. Food and Drug Administration 2018. Guidances (Drugs). Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm (accessed on June 13, 2018).