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BASE: Bronchiectasis Severity and Exacerbation Risk Study (BASE)

2026年5月15日 更新者:Ahmad Shaddad、Assiut University

BASE: Bronchiectasis Assessment of Severity and Exacerbations for Baseline Severity Classification and One-Year Exacerbation Risk Prediction in Non-Cystic Fibrosis Bronchiectasis

Non-cystic fibrosis bronchiectasis (NCFB) is a chronic airway disease characterized by permanent bronchial dilatation, impaired mucus clearance, recurrent infection, airway inflammation, and repeated exacerbations. Existing bronchiectasis severity tools are clinically useful, but many depend on prior exacerbation history, hospitalization history, subjective symptom assessment, or culture-based microbiological classification.

This prospective observational cohort study aims to develop and validate the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework. BASE is designed to classify current bronchiectasis severity and predict 12-month exacerbation risk using objective baseline functional, radiological, oxygenation, and inflammatory variables. Detailed methodological specifications, including variable definitions, scoring architecture, endpoint hierarchy, development-validation governance, and analytical integrity rules, are archived in a restricted-access Zenodo record: https://doi.org/10.5281/zenodo.20143505

.

Participants will receive routine clinical care, and no treatment or intervention will be assigned by the study protocol. Patients will be followed for 12 months to record bronchiectasis exacerbations, hospitalization, lung-function change, inflammatory marker change, and clinical outcomes. The Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework includes two linked baseline models: the BASE Severity model (BASE-S) for current bronchiectasis severity classification and the BASE Prognostic model (BASE-P) for prediction of 12-month exacerbation risk. Both models will be derived in the development cohort and applied unchanged to the validation cohort.

調査の概要

詳細な説明

Non-cystic fibrosis bronchiectasis (NCFB) is a chronic airway disease characterized by permanent bronchial dilatation, impaired mucociliary clearance, recurrent infection, persistent airway inflammation, and repeated exacerbations. Disease severity and future exacerbation risk are heterogeneous among patients, and accurate baseline risk stratification remains clinically important for follow-up planning, preventive strategies, and early identification of patients at higher risk of clinical deterioration.

Existing bronchiectasis severity tools provide useful clinical stratification, but several established approaches include variables such as previous exacerbation history, previous hospitalization, subjective dyspnea assessment, or culture-based microbiological classification. These variables may be influenced by health-care access, documentation quality, patient perception, physician decision thresholds, sputum sampling quality, timing of culture, and prior antibiotic exposure. Therefore, there is a need to evaluate whether a focused objective disease-signature framework can classify current disease severity and predict future exacerbation risk using baseline functional, radiological, oxygenation, and inflammatory variables.

The Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework is designed as a baseline clinical assessment model for adults with non-cystic fibrosis bronchiectasis (NCFB). The framework includes two linked baseline models: the BASE Severity model (BASE-S) for current bronchiectasis severity classification and the BASE Prognostic model (BASE-P) for prediction of 12-month bronchiectasis exacerbation risk. Detailed variable definitions, scoring rules, point-conversion methods, endpoint hierarchy, development-validation governance, and analytic specifications are archived in a restricted-access Zenodo record before final model derivation and validation: https://doi.org/10.5281/zenodo.20143505

.

This is a prospective observational cohort study. Participants will not be assigned to any treatment or intervention by the study protocol. All clinical management decisions, including airway clearance, antibiotic treatment, inhaled therapy, microbiological testing, follow-up frequency, and hospitalization decisions, will follow routine clinical care and institutional practice.

Eligible participants will undergo baseline clinical assessment, pulmonary function assessment, chest imaging review, resting room-air oxygenation assessment, and inflammatory marker assessment. Follow-up will continue for 12 months. During follow-up, bronchiectasis exacerbations, severe exacerbations requiring hospitalization, lung-function change, inflammatory marker change, treatment escalation, and clinical outcomes will be recorded using structured data collection forms.

The study will use a development-validation design. The BASE-S and BASE-P equations, point structures, severity categories, and risk bands will be derived in the development cohort. The final locked models will then be applied unchanged to the validation cohort. No refitting, recalibration, variable substitution, point-score modification, or threshold retuning will be performed in the validation cohort. Model performance will be assessed using discrimination, calibration, risk-band separation, clinical utility where applicable, and comparison with established bronchiectasis severity tools where complete data are available.

The intended output is a practical baseline disease-signature framework that can support severity classification and one-year exacerbation-risk prediction in adults with non-cystic fibrosis bronchiectasis (NCFB), while preserving separation from any future interventional treatment studies.

研究の種類

観察的

入学 (推定)

750

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Asyut Egypt
      • Asyut、Asyut Egypt、エジプト、71515
        • 募集
        • Assiut university-Faculty of Medicine
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

Adult patients with non-cystic fibrosis bronchiectasis (NCFB) attending outpatient clinics, inpatient wards, or respiratory follow-up services at Assiut University Hospitals during the study enrollment period will be prospectively screened for eligibility. Eligible participants will have clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB) and will undergo baseline assessment using the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework, followed by 12-month follow-up for bronchiectasis exacerbations, hospitalization, functional change, inflammatory marker change, and clinical outcomes. Participants will receive routine clinical care, and no treatment or intervention will be assigned by the study protocol.

説明

Inclusion Criteria:

  • Adult patients aged 18 years or older.
  • Diagnosis of non-cystic fibrosis bronchiectasis (NCFB) based on clinical assessment and high-resolution computed tomography (HRCT).
  • Clinically stable or routinely assessed patients with non-cystic fibrosis bronchiectasis (NCFB) eligible for baseline severity and risk assessment.
  • Patients attending outpatient clinic, inpatient ward, or respiratory follow-up services at Assiut University Hospitals during the study enrollment period.
  • Patients suitable for prospective baseline assessment using the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework.
  • Ability to undergo routine clinical, functional, radiological, oxygenation, and inflammatory assessment according to the study protocol.
  • Ability to complete planned 12-month follow-up for bronchiectasis exacerbation and outcome assessment.
  • Written informed consent obtained from the patient or legal representative.

Exclusion Criteria:

  • Cystic fibrosis-related bronchiectasis.
  • Traction bronchiectasis due to advanced fibrotic interstitial lung disease as the dominant respiratory diagnosis.
  • Active pulmonary tuberculosis at enrollment.
  • Active nontuberculous mycobacterial pulmonary disease requiring specific treatment at enrollment.
  • Active malignancy or terminal non-respiratory illness expected to prevent 12-month follow-up.
  • Acute life-threatening illness preventing safe enrollment or baseline assessment.
  • Recent major thoracic surgery or acute thoracic trauma interfering with baseline respiratory assessment.
  • Inability to complete the required baseline or Bronchiectasis Assessment of Severity and Exacerbations (BASE) assessment according to the study protocol.
  • Inability or unwillingness to complete planned 12-month follow-up.
  • Refusal to participate.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
Development Cohort
Adults with non-cystic fibrosis bronchiectasis (NCFB) enrolled in the prospective observational cohort and assigned to the development subset. This cohort will be used to derive the Bronchiectasis Assessment of Severity and Exacerbations (BASE) equation, point structure, severity classification, and 12-month exacerbation-risk bands.
Validation Cohort
Adults with non-cystic fibrosis bronchiectasis (NCFB) enrolled in the prospective observational cohort and assigned to the validation subset. This cohort will be used to evaluate the fixed Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework without refitting, recalibration, variable substitution, or threshold modification.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Twelve-Month Bronchiectasis Exacerbation Risk Predicted by the BASE Prognostic Model (BASE-P)
時間枠:Baseline to 12 months follow-up.
Occurrence of at least one bronchiectasis exacerbation during 12-month follow-up, used as the primary clinical endpoint for development and validation of the BASE Prognostic model (BASE-P). BASE-P is the 12-month risk-prediction component of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework for adults with non-cystic fibrosis bronchiectasis (NCFB). Specific point ranges and risk categories have not yet been established and will be derived in the development cohort before locked validation. Higher BASE-P predicted risk values indicate higher expected exacerbation risk. Unit of Measure: Percentage of participants.
Baseline to 12 months follow-up.

二次結果の測定

結果測定
メジャーの説明
時間枠
Current Bronchiectasis Severity Classification by the BASE Severity Model (BASE-S)
時間枠:Baseline Day 1
Baseline bronchiectasis severity classification using the BASE Severity model (BASE-S). BASE-S is the current severity-classification component of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework for adults with non-cystic fibrosis bronchiectasis (NCFB). Specific severity point ranges and categories have not yet been established and will be derived in the development cohort before locked validation. Higher BASE-S severity categories indicate greater baseline bronchiectasis disease burden. Unit of Measure: Percentage of participants.
Baseline Day 1
Time to First Bronchiectasis Exacerbation
時間枠:Baseline to 12 months follow-up.
Time from baseline assessment to the first recorded bronchiectasis exacerbation during follow-up. Participants without exacerbation will be censored at the last available follow-up date or at 12 months. Shorter time to first bronchiectasis exacerbation indicates earlier clinical deterioration and worse outcome. Unit of Measure: Days.
Baseline to 12 months follow-up.
Number of Bronchiectasis Exacerbations During Follow-Up
時間枠:Baseline to 12 months follow-up.
Total number of bronchiectasis exacerbations recorded for each participant during the 12-month follow-up period. Higher exacerbation count indicates greater disease instability and worse clinical outcome. Unit of Measure: Number of events.
Baseline to 12 months follow-up.
Severe Bronchiectasis Exacerbation Requiring Hospitalization
時間枠:Baseline to 12 months follow-up.
Occurrence of at least one bronchiectasis exacerbation requiring hospital admission during the 12-month follow-up period. Hospitalization-requiring exacerbation indicates more severe clinical deterioration and worse outcome. Unit of Measure: Percentage of participants.
Baseline to 12 months follow-up.
Change in Forced Expiratory Volume in One Second Percent Predicted (FEV1% Predicted)
時間枠:Baseline to 12 months follow-up.
Change in forced expiratory volume in one second percent predicted (FEV1% predicted) measured by spirometry from baseline to 12 months. Change will be calculated as the 12-month value minus the baseline value. Lower or declining FEV1% predicted indicates worsening airflow limitation and worse functional outcome. Unit of Measure: Percentage points.
Baseline to 12 months follow-up.
Change in Resting Room-Air Oxygen Saturation Measured by Pulse Oximetry (SpO₂)
時間枠:Baseline to 12 months follow-up.
Change in resting room-air oxygen saturation measured by pulse oximetry (SpO₂) from baseline to 12 months, when clinically feasible. Change will be calculated as the 12-month value minus the baseline value. Lower or declining SpO₂ indicates worse oxygenation reserve. Unit of Measure: Percentage points.
Baseline to 12 months follow-up.
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
時間枠:Baseline to 12 months follow-up.
Change in neutrophil-to-lymphocyte ratio (NLR), calculated from complete blood count as absolute neutrophil count divided by absolute lymphocyte count, from baseline to 12 months. Higher or increasing NLR indicates greater systemic neutrophilic inflammatory activity. Unit of Measure: Unitless ratio.
Baseline to 12 months follow-up.
Change in C-Reactive Protein (CRP)
時間枠:Baseline to 12 months follow-up.
Change in C-reactive protein (CRP) from baseline to 12 months using routine laboratory measurement. Change will be calculated as the 12-month value minus the baseline value. Higher or increasing CRP indicates greater systemic inflammatory activity. Unit of Measure: Milligrams per liter (mg/L).
Baseline to 12 months follow-up.
Bronchiectasis-Related Hospital Admission
時間枠:Baseline to 12 months follow-up.
Occurrence of hospital admission related to bronchiectasis deterioration, respiratory infection, bronchiectasis exacerbation, worsening respiratory symptoms, or related respiratory failure during follow-up. Occurrence of bronchiectasis-related hospital admission indicates worse clinical outcome. Unit of Measure: Percentage of participants.
Baseline to 12 months follow-up.
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework With the Bronchiectasis Severity Index (BSI)
時間枠:Baseline to 12 months follow-up.
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework with the Bronchiectasis Severity Index (BSI) for prediction of 12-month bronchiectasis exacerbation outcomes where complete data are available. Higher discrimination and better calibration indicate better predictive performance. Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale).
Baseline to 12 months follow-up.
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework With the FACED Score
時間枠:Baseline to 12 months follow-up.
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework with the FACED score for prediction of 12-month bronchiectasis exacerbation outcomes where complete data are available. Higher discrimination and better calibration indicate better predictive performance. Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale).
Baseline to 12 months follow-up.
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework With the E-FACED Score
時間枠:Baseline to 12 months follow-up.
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework with the E-FACED score for prediction of 12-month bronchiectasis exacerbation outcomes where complete data are available. Higher discrimination and better calibration indicate better predictive performance. Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale).
Baseline to 12 months follow-up.
Change in Modified Reiff Score
時間枠:Baseline to 12 months follow-up.
Change in Modified Reiff score from baseline to 12 months. The Modified Reiff score assesses radiological bronchiectasis extent and bronchial dilatation severity across six lobes, including the lingula, with a total score ranging from 0 to 18. Change will be calculated as the 12-month value minus the baseline value. Higher or increasing Modified Reiff score indicates greater structural radiological bronchiectasis burden or progression. Unit of Measure: Points.
Baseline to 12 months follow-up.

その他の成果指標

結果測定
メジャーの説明
時間枠
Discrimination Performance of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework for Twelve-Month Bronchiectasis Exacerbation Risk
時間枠:Baseline to 12 months follow-up.
Evaluation of the discrimination performance of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework for prediction of bronchiectasis exacerbation during 12-month follow-up using area under the receiver operating characteristic curve analysis. BASE is a novel baseline disease-signature model undergoing prospective derivation and validation in adults with non-cystic fibrosis bronchiectasis (NCFB). Specific bedside thresholds and operational risk categories have not yet been established and will be derived in the development cohort before locked validation. Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale). Higher values indicate better discrimination performance.
Baseline to 12 months follow-up.
Calibration Performance of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework for Twelve-Month Bronchiectasis Exacerbation Risk
時間枠:Baseline to 12 months follow-up.
Assessment of calibration performance of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework for prediction of bronchiectasis exacerbation during 12-month follow-up. Calibration performance will be assessed using calibration intercept and calibration slope where applicable. BASE is a novel baseline disease-signature model undergoing prospective derivation and validation in adults with non-cystic fibrosis bronchiectasis (NCFB). Unit of Measure: calibration slope values closer to 1 indicate better calibration performance.
Baseline to 12 months follow-up.
Clinical Utility of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework
時間枠:Baseline to 12 months follow-up.
Assessment of clinical utility of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework using decision curve analysis and net benefit across clinically relevant threshold probabilities for prediction of bronchiectasis exacerbation during 12-month follow-up. BASE is a novel baseline disease-signature model undergoing prospective derivation and validation in adults with non-cystic fibrosis bronchiectasis (NCFB). Unit of Measure: Net benefit (unitless). Higher net benefit indicates greater clinical utility across the evaluated threshold probability range.
Baseline to 12 months follow-up.
Risk-Band Separation of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework
時間枠:Baseline to 12 months follow-up.
Assessment of separation between predefined Bronchiectasis Assessment of Severity and Exacerbations (BASE) risk categories for 12-month bronchiectasis exacerbation outcomes. BASE risk categories will be derived in the development cohort before locked validation. Outcome differences across risk categories will be assessed using exacerbation occurrence, exacerbation burden, and hospitalization-related outcomes where applicable. Unit of Measure: Percentage of participants. Higher observed event rates in higher BASE risk categories indicate better risk-band separation.
Baseline to 12 months follow-up.
Regression-Based Contribution Analysis of Bronchiectasis Assessment of Severity and Exacerbations (BASE) Candidate Variables
時間枠:Baseline to 12 months follow-up.
Assessment of the contribution of individual Bronchiectasis Assessment of Severity and Exacerbations (BASE) candidate variables to prediction of 12-month bronchiectasis exacerbation risk using regression coefficient analysis. Candidate domains include functional assessment, radiological assessment, oxygenation assessment, and inflammatory assessment. Unit of Measure: Regression coefficients (unitless). Larger absolute coefficient values indicate greater contribution to the prediction model.
Baseline to 12 months follow-up.
Ablation Analysis of Bronchiectasis Assessment of Severity and Exacerbations (BASE) Model Components
時間枠:Baseline to 12 months follow-up.
Assessment of changes in predictive discrimination performance for 12-month bronchiectasis exacerbation risk following sequential removal of Bronchiectasis Assessment of Severity and Exacerbations (BASE) model components. The analysis will evaluate the contribution of functional, radiological, oxygenation, and inflammatory domains to overall model performance. Unit of Measure: Area under the receiver operating characteristic curve difference (0-1 scale). Larger changes indicate greater contribution of the removed component.
Baseline to 12 months follow-up.
Incremental Discrimination Performance of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework Compared With Established Bronchiectasis Severity Tools
時間枠:Baseline to 12 months follow-up.
Assessment of the incremental discrimination performance of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework compared with established bronchiectasis severity tools, including the Bronchiectasis Severity Index (BSI), FACED score, and E-FACED score, for prediction of 12-month bronchiectasis exacerbation outcomes where complete data are available. Unit of Measure: Area under the receiver operating characteristic curve difference (0-1 scale). Higher positive values indicate greater incremental discrimination improvement.
Baseline to 12 months follow-up.
Incremental Calibration Performance of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework Compared With Established Bronchiectasis Severity Tools
時間枠:Baseline to 12 months follow-up.
Assessment of the incremental calibration performance of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework compared with established bronchiectasis severity tools, including the Bronchiectasis Severity Index (BSI), FACED score, and E-FACED score, for prediction of 12-month bronchiectasis exacerbation outcomes where complete data are available. Unit of Measure: Unitless calibration coefficients. Calibration intercept values closer to 0 and calibration slope values closer to 1 indicate better calibration performance.
Baseline to 12 months follow-up.
Association Between Bronchiectasis Assessment of Severity and Exacerbations (BASE) Severity Categories and Twelve-Month Exacerbation Outcomes
時間枠:Baseline to 12 months follow-up.
Assessment of the association between Bronchiectasis Assessment of Severity and Exacerbations (BASE) baseline severity categories and bronchiectasis exacerbation outcomes during 12-month follow-up. BASE severity categories will be derived in the development cohort and applied unchanged to the validation cohort. Unit of Measure: Percentage of participants. Higher exacerbation rates in higher BASE severity categories indicate stronger association between baseline disease severity and future clinical instability.
Baseline to 12 months follow-up.
Association Between Bronchiectasis Assessment of Severity and Exacerbations (BASE) Risk Categories and Hospitalization Outcomes
時間枠:Baseline to 12 months follow-up.
Assessment of the association between Bronchiectasis Assessment of Severity and Exacerbations (BASE) risk categories and bronchiectasis-related hospitalization during 12-month follow-up. BASE risk categories will be derived in the development cohort and applied unchanged to the validation cohort. Unit of Measure: Percentage of participants. Higher hospitalization rates in higher BASE risk categories indicate stronger association between predicted risk category and clinically severe outcomes.
Baseline to 12 months follow-up.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Aliae A. Hussien, MD、Assiut University
  • 主任研究者:Maiada K. Hashem, MD、Assiut University
  • 主任研究者:Ahmad M Shaddad, MD、Assiut University
  • 主任研究者:Alaa Sayed, MD、Assiut University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年9月11日

一次修了 (推定)

2027年1月1日

研究の完了 (推定)

2027年2月1日

試験登録日

最初に提出

2026年5月15日

QC基準を満たした最初の提出物

2026年5月15日

最初の投稿 (実際)

2026年5月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月20日

QC基準を満たした最後の更新が送信されました

2026年5月15日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

De-identified individual participant data may be made available only upon reasonable scientific request and after approval by the principal investigator, the institutional authority, and the relevant ethics committee when applicable. Data sharing will be restricted to approved research purposes and will require a formal data use agreement. No directly identifiable participant information will be shared. The Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework, scoring architecture, analytic code, model coefficients, and related intellectual materials remain under the authority of the investigators and Assiut University unless separately released by formal written authorization.

IPD 共有時間枠

Beginning 12 months after publication of the primary study results and for 3 years thereafter.

IPD 共有アクセス基準

Access may be granted to qualified researchers submitting a methodologically sound proposal for scientific purposes related to non-cystic fibrosis bronchiectasis (NCFB). Requests must be reviewed and approved by the principal investigator and institutional authority. Approved requesters must sign a data use agreement covering confidentiality, restricted use, data security, no re-identification attempts, no unauthorized redistribution, and acknowledgement of the investigators and Assiut University.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

試験データ・資料

  1. 研究プロトコル
    情報識別子:10.5281/zenodo.20143505
    情報コメント:The locked BASE Version 1.0 protocol is included in the Zenodo methodological archive according to the record access conditions.
  2. 統計分析計画
    情報識別子:10.5281/zenodo.20143505
    情報コメント:The locked BASE Version 1.0 statistical analysis plan and supporting methodological materials are included in the Zenodo methodological archive according to the record access conditions.
  3. インフォームド コンセント フォーム
    情報識別子:10.5281/zenodo.20143505
    情報コメント:The informed consent form may be made available through the Zenodo methodological archive or institutional request pathway according to ethics and institutional approval requirements.

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いいえ

米国FDA規制機器製品の研究

いいえ

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