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Three conditions are required: diet and exercise therapy must have been ineffective for at least 6 months, the patient must have a BMI of 35 or higher (or a BMI of 27 or higher with at least two of the following: hypertension, dyslipidemia, or type 2 diabetes), and the prescribing medical institution must meet the requirements of a facility certified by the Japan Society for the Study of Obesity or similar organizations