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O 37.5 mg day. Table 5 enumerates adverse events that occurred at an incidence of 1% or more among patients treated with PAXIL CR who participated in three, 12-week, placebo-controlled trials in PMDD in which patients were dosed at 12.5 mg day or 25 mg day and in one 12-week placebo-controlled trial in which patients were dosed for 2 weeks prior to the onset of menses (luteal phase dosing) at 12.5 mg day or 25 mg day. Reported adverse events were classified using a standard COSTART-based Dictionary terminology. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied. Table 1. Treatment-Emergent Adverse Events Occurring in & 179; 1% of Patients Treated With PAXIL CR in a Pool of 2 Studies in Major Depressive Disorder1,2 Body System Adverse Event % Reporting Event PAXIL CR (n = 212) Placebo (n = 211) Body as a Whole Headache 27% 20% Asthenia 14% 9% Infection3 8% 5% Abdominal Pain 7% 4% Back Pain 5% 3% Trauma4 5% 1% Pain5 3% 1% Allergic Reaction6 2% 1% Cardiovascular System Tachycardia 1% 0% Vasodilatation7 2% 0% Dig