 Study abstract: schemapurposesubjectendpointdefinition of treatmentanticipated enrollment numberprogress of the study Enrollment status: per participating sitetotal Monitoring activity: contents of activityCRF collection per siteuncollected CRF, inquiry Review of the eligible treatment case:the case of ineligible possibilitythe case determined as ineligiblenumber of eligible casethe case determined as non-treatmenttotal number of treatment case Review of a target population for analysis: the number of cases targeted for efficacy analysissafety analysis Patient background Treatment time-course: summary of on-treatment and discontinuationsummary of reason for discontinuationlist of reason for discontinuation Protocol violationdeviation Safety evaluation: serious adverse reaction, eventthe case which was notified to the study group among the adverse reactions, events with an ordinary reportgeneral adverse events Others 