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no patient will be harmed by the trial. the patients will not be exposed to any risks. if an unexpected adverse event occurs during the trial, it will be recorded in the case report form (crf), and the cause of adverse event and its severity will be evaluated. if the investigator considers that the situation indicates the patient should be withdrawn from the trial, the patient will be withdrawn from the trial. the researcher will inform the sponsor and regulatory authority of the outcome. if a patient dies or refuses to continue to participate in the trial, the assessment of this patient will be discontinued without replacement, and its details will be recorded.

the study investigators will examine the eligibility of patients using the following basic information: first name, last name, birth date, family relationship, address, telephone number, mailing address, etc., in a clinical report form. for patients who are eligible based on the inclusion and exclusion criteria, one of two investigators will complete the following data: first name, family relationship, address, telephone number, last menstrual period, height, and weight. the cfs diagnosis and its severity will be confirmed according to the 2002 international consensus criteria for chronic fatigue syndrome (cfs) [ 1 ]. the severity is classified into five levels: (1) mild; (2) moderate; (3) severe; (4) very severe; and (5) critically severe. the study investigators will use a 4-point scale to evaluate the patient’s condition at screening: (1) inexcusable (including serious physical and psychological disorder); (2) not harmful to continue; (3) not harmful to dropout; and (4) harmful to dropout. for patients that meet the above inclusion criteria, the reason for patients’ condition at screening will be recorded on the clinical report form. the eligible patients will be randomly assigned to the study group and the control group in a ratio of 1:1. the ratio was determined to be approximately 1:1 because of the study period and number of subjects.the patient flow diagram is shown in fig. 3.

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