“…Recognizing that abstinence may be an overly narrow, insensitive outcome, the Food and Drug Administration (FDA) now accepts an additional outcome, i.e., no heavy drinking days (HDD; >3 drinks for females, >4 for males) (Food and Drug Administration, 2015), with the percentage of participants having no HDD compared between treatment arms. However, the no-HDD outcome may also be overly narrow and insensitive, since it classifies patients as treatment failures after any HDD, although some of these patients substantially reduce their drinking and improve in how they feel and function (Maisto et al, 2018;Wilson et al, 2016;Witkiewitz et al, 2017c). An alternative clinical trials outcome to those currently accepted (Food and Drug Administration, 2015;Maisto et al, 2018;Wilson et al, 2016;Witkiewitz et al, 2017c), which is used by the European Medicines Agency (EMA), is a 2-level reduction in the World Health Organization (WHO) 4-category classification of risk drinking levels: veryhigh, high, moderate and low (European Medicines Agency, 2010;World Health Organization, 2000).…”