项目概览、参与者管理初步优化(未接入真实数据)
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@@ -28,7 +28,7 @@ async def _validate_site_subject(db: AsyncSession, study_id: uuid.UUID, site_id:
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result = await db.execute(select(Subject).where(Subject.id == subject_id))
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subj = result.scalar_one_or_none()
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if not subj or subj.study_id != study_id:
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raise ValueError("受试者不属于当前项目")
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raise ValueError("参与者不属于当前项目")
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async def create_ae(
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@@ -16,6 +16,10 @@ async def create(db: AsyncSession, study_in: StudyCreate, *, created_by: uuid.UU
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protocol_no=study_in.protocol_no,
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phase=study_in.phase,
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status=study_in.status,
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visit_interval_days=study_in.visit_interval_days,
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visit_total=study_in.visit_total,
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visit_window_start_offset=study_in.visit_window_start_offset,
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visit_window_end_offset=study_in.visit_window_end_offset,
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created_by=created_by,
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)
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db.add(study)
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+33
-12
@@ -6,6 +6,8 @@ from sqlalchemy import select, update as sa_update
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from sqlalchemy.ext.asyncio import AsyncSession
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from app.crud import visit as visit_crud
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from app.models.study import Study
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from app.models.visit import Visit
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from app.models.site import Site
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from app.models.subject import Subject
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from app.schemas.subject import SubjectCreate, SubjectUpdate
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@@ -26,6 +28,7 @@ async def create_subject(db: AsyncSession, study_id: uuid.UUID, subject_in: Subj
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subject_no=subject_in.subject_no,
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status="SCREENING",
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screening_date=subject_in.screening_date,
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consent_date=subject_in.consent_date,
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enrollment_date=None,
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completion_date=None,
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drop_reason=None,
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@@ -41,7 +44,6 @@ async def create_subject(db: AsyncSession, study_id: uuid.UUID, subject_in: Subj
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visit_in=None,
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subject=subject,
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visit_code="V0",
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visit_name="Screening",
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planned_date=subject.screening_date,
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)
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return subject
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@@ -74,25 +76,44 @@ async def generate_default_visits(db: AsyncSession, subject: Subject) -> None:
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# Baseline + Follow-up visits based on enrollment_date
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if not subject.enrollment_date:
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return
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result = await db.execute(select(Study).where(Study.id == subject.study_id))
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study = result.scalar_one_or_none()
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if not study:
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return
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visit_total = study.visit_total or 3
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visit_interval_days = study.visit_interval_days or 30
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window_start_offset = study.visit_window_start_offset
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window_end_offset = study.visit_window_end_offset
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baseline_date = subject.enrollment_date
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follow1 = baseline_date + timedelta(days=30)
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follow2 = baseline_date + timedelta(days=60)
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visits_data = [
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("V1", "Baseline", baseline_date),
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("FU1", "Follow-up 1", follow1),
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("FU2", "Follow-up 2", follow2),
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]
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for code, name, plan_date in visits_data:
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result = await db.execute(select(Visit.visit_code).where(Visit.subject_id == subject.id))
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existing_codes = {row[0] for row in result.all()}
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if "V1" not in existing_codes:
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window_start = baseline_date + timedelta(days=window_start_offset) if window_start_offset is not None else None
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window_end = baseline_date + timedelta(days=window_end_offset) if window_end_offset is not None else None
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await visit_crud.create_visit(
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db,
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study_id=subject.study_id,
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visit_in=None,
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subject=subject,
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visit_code=code,
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visit_name=name,
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planned_date=plan_date,
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visit_code="V1",
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planned_date=baseline_date,
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window_start=window_start,
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window_end=window_end,
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)
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await visit_crud.create_followup_visits(
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db,
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study_id=subject.study_id,
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subject=subject,
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base_date=baseline_date,
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visit_total=visit_total,
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visit_interval_days=visit_interval_days,
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window_start_offset=window_start_offset,
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window_end_offset=window_end_offset,
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)
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async def update_subject(db: AsyncSession, subject: Subject, subject_in: SubjectUpdate) -> Subject:
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update_data = subject_in.model_dump(exclude_unset=True)
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@@ -13,7 +13,7 @@ async def _ensure_subject(db: AsyncSession, study_id: uuid.UUID, subject_id: uui
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result = await db.execute(select(Subject).where(Subject.id == subject_id))
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subject = result.scalar_one_or_none()
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if not subject or subject.study_id != study_id:
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raise ValueError("受试者不属于当前项目")
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raise ValueError("参与者不属于当前项目")
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async def create_history(
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@@ -1,4 +1,5 @@
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import uuid
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from datetime import date, timedelta
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from typing import Sequence
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from sqlalchemy import select, update as sa_update
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@@ -16,19 +17,19 @@ async def create_visit(
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visit_in: VisitCreate | None,
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subject: Subject,
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visit_code: str,
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visit_name: str,
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planned_date,
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window_start: date | None = None,
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window_end: date | None = None,
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) -> Visit:
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visit = Visit(
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study_id=study_id,
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subject_id=subject.id,
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visit_code=visit_code,
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visit_name=visit_name,
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planned_date=planned_date,
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actual_date=None,
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status="PLANNED",
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window_start=visit_in.window_start if visit_in else None,
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window_end=visit_in.window_end if visit_in else None,
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window_start=window_start if window_start is not None else (visit_in.window_start if visit_in else None),
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window_end=window_end if window_end is not None else (visit_in.window_end if visit_in else None),
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notes=None,
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)
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db.add(visit)
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@@ -49,6 +50,12 @@ async def get_visit(db: AsyncSession, visit_id: uuid.UUID) -> Visit | None:
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async def update_visit(db: AsyncSession, visit: Visit, visit_in: VisitUpdate) -> Visit:
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update_data = visit_in.model_dump(exclude_unset=True)
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if "actual_date" in update_data and update_data["actual_date"] is not None and "status" not in update_data:
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actual_date = update_data["actual_date"]
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if (visit.window_start and actual_date < visit.window_start) or (visit.window_end and actual_date > visit.window_end):
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update_data["status"] = "OVERDUE"
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else:
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update_data["status"] = "DONE"
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if update_data:
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await db.execute(
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sa_update(Visit)
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@@ -63,3 +70,44 @@ async def update_visit(db: AsyncSession, visit: Visit, visit_in: VisitUpdate) ->
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async def delete_visit(db: AsyncSession, visit: Visit) -> None:
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await db.delete(visit)
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await db.commit()
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async def create_followup_visits(
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db: AsyncSession,
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*,
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study_id: uuid.UUID,
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subject: Subject,
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base_date: date,
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visit_total: int | None,
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visit_interval_days: int | None,
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window_start_offset: int | None,
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window_end_offset: int | None,
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) -> Sequence[Visit]:
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if not visit_total or not visit_interval_days or visit_total < 2:
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return []
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result = await db.execute(select(Visit.visit_code).where(Visit.subject_id == subject.id))
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existing_codes = {row[0] for row in result.all()}
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created: list[Visit] = []
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for index in range(2, visit_total + 1):
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code = f"V{index}"
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if code in existing_codes:
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continue
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planned_date = base_date + timedelta(days=visit_interval_days * (index - 1))
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window_start = (
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planned_date + timedelta(days=window_start_offset) if window_start_offset is not None else None
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)
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window_end = planned_date + timedelta(days=window_end_offset) if window_end_offset is not None else None
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created.append(
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await create_visit(
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db,
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study_id=study_id,
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visit_in=None,
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subject=subject,
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visit_code=code,
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planned_date=planned_date,
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window_start=window_start,
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window_end=window_end,
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)
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)
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return created
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