chufangao/CTO huggingface dataset:
Clinical trial NCT03831880: Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD
Official title: A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 87.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-07
Primary completion date: 2020-08-28
Completion date: 2020-08-28
Baseline population: The safety analysis set included all participants who received at least 1 dose of study intervention. The participants were analyzed according to the intervention they actually received.
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT04102579: Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
Acronym: KINECT-HD
Sponsor: Neurocrine Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 128.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-13
Primary completion date: 2021-10-15
Completion date: 2021-10-26
Baseline population: All participants who received at least 1 dose of study drug.
Plan to share individual participant data: NO
Clinical trial NCT03905330: A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)
Official title: MRX-502: Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC) - MARCH-PFIC
Acronym: MARCH-PFIC
Sponsor: Mirum Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 93.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-09
Primary completion date: 2022-09-01
Completion date: 2022-09-01
Plan to share individual participant data: NO
Clinical trial NCT03579472: M7824 and Eribulin Mesylate in Treating Patients With Metastatic Triple Negative Breast Cancer
Official title: A Phase Ib Trial of M7824 and Eribulin in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to the fact that the sponsor decided not to move forward with the development of M7824
Enrollment: 38.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-05-30
Primary completion date: 2022-09-21
Completion date: 2022-09-21
Clinical trial NCT02663518: A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors
Official title: A Phase 1a/1b Dose Escalation and Expansion Trial of TTI-621, a Novel Biologic Targeting CD47, in Subjects With Relapsed or Refractory Hematologic Malignancies and Selected Solid Tumors
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Pfizer decided terminating study for administrative reasons on 22Mar2022 (stopping enrollment as of 15Apr2022). The decision wasn't due to safety concerns or requests from regulatory authorities.
Enrollment: 249.0 (ACTUAL)
Number of arms: 16.0
Start date: 2016-01-28
Primary completion date: 2022-11-23
Completion date: 2022-11-23
Baseline population: Analysis population included all the participants who received at least one dose of study treatment.
Plan to share individual participant data: NO
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT03762265: A Study of PRN1008 in Patients With Pemphigus
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor Rilzabrutinib (PRN1008) in Moderate to Severe Pemphigus
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision based on lack of efficacy
Enrollment: 131.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-08
Primary completion date: 2021-07-30
Completion date: 2021-12-17
Baseline population: Analysis was performed on randomized population.
Limitations and caveats: Study was terminated prematurely by the Sponsor.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT02885324: Pilot Study of Cabozantinib for Recurrent or Progressive Central Nervous System Tumors in Children
Official title: Pilot Study of Cabozantinib for Recurrent or Progressive Central Nervous System Tumors in Children
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Failure to meet accrual goals.
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-05-18
Primary completion date: 2020-08-25
Completion date: 2020-08-25
Limitations and caveats: Early termination leading to small numbers of subjects analyzed.
Plan to share individual participant data: NO
Clinical trial NCT04631016: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of MEDI3506 in Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis (FRONTIER 4)
Acronym: FRONTIER-4
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 136.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-14
Primary completion date: 2023-05-30
Completion date: 2023-11-13
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT03610581: Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With HPV16 or HPV18 Infection of the Cervix
Official title: A Randomized, Double-blind, Placebo-controlled, First-in-Human, Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Otherwise Healthy Women With HPV16 or 18 Infection of the Cervix
Sponsor: Janssen Vaccines & Prevention B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Low enrolment and increasing COVID restrictions, following an earlier enrolment pause in April made it clear that completion of the study would not be feasible
Enrollment: 9.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-09-27
Primary completion date: 2020-10-15
Completion date: 2020-10-15
Baseline population: Full analysis set (FAS) included all participants with at least one vaccination.
Limitations and caveats: As the study was terminated prematurely, the Sponsor performed a limited analysis on the available data to meet the requirement for reporting the study.
Clinical trial NCT03996057: Methenamine in a Non-antibiotic, Multimodal Approach to UTI Prevention
Official title: The Efficacy and Effect of Methenamine Hippurate in a Non-antibiotic, Multimodal Approach to UTI Prevention
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Project canceled due to PI leaving institution, staff changes and COVID~Project canceled for other reason , describe: - Due to staff changes and COVID~Project canceled due to PI leaving, staff changes and COVID
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-20
Primary completion date: 2022-02-11
Completion date: 2022-02-11
Plan to share individual participant data: NO
Clinical trial NCT05062759: Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Adolescent and Young Adult Participants With Moderate to Severe Asthma (VECTOR)
Acronym: VECTOR
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 70.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-23
Primary completion date: 2022-03-21
Completion date: 2022-07-18
Baseline population: All patients randomised and receiving any study intervention were included in the Full analysis set, irrespective of their CSP adherence and continued participation in the study.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
Clinical trial NCT02846766: Study of Lenvatinib in Patients With Advanced Cancer and Aberrations in FGF/FGFR Signaling
Official title: A Multicenter, Histology-Independent Study of the Fibroblast Growth Factor Receptor (FGFR) Inhibitor Lenvatinib (E7080) in Patients With Advanced Cancer and Aberrations in FGF/FGFR Signaling
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Unable to execute a contract agreement with the drug manufacturer.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-01
Primary completion date: 2020-06-01
Completion date: 2021-06-01
Plan to share individual participant data: NO
Clinical trial NCT04102202: BOL-DP-o-05 as an Add-On Treatment of Subjects With Newly Diagnosed Type 1 Diabetes Mellitus
Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, Safety & Efficacy Trial of BOL-DP-o-05 as an Add-On Treatment for Preservation of Beta-Cell Function in Subjects With Newly-Diagnosed T1DM
Sponsor: Breath of Life International Pharma Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Due to company strategic decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-15
Primary completion date: 2021-03-22
Completion date: 2021-03-22
Plan to share individual participant data: NO
Clinical trial NCT04762160: SYMPHONY-2, A Trial to Examine Combination of Tazemetostat With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma
Official title: SYMPHONY-II: A Phase II Open-Label, Multicenter Trial of Oral Tazemetostat in Combination With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma
Sponsor: Ipsen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Decision to terminate EZH-1401 was solely due to company business decision.
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-15
Primary completion date: 2022-03-22
Completion date: 2022-03-22
Baseline population: The Safety population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety evaluation, regardless of enhancer of zeste homolog 2 (EZH2) mutation status (mutant-type \[MT\] or wild-type \[WT\]).
Limitations and caveats: The study was terminated early due to business reasons prior to enrolling the target number of participants needed to achieve target power and was insufficient to produce statistically reliable results and was not due to any safety concerns. No summary statistics are available given the limited data from the small number of evaluable participants and individual participant data are also not presented to protect the privacy of the individuals.
Plan to share individual participant data: NO
Clinical trial NCT03493854: A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer
Official title: A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Patients With HER2-Positive Early Breast Cancer
Acronym: FeDeriCa
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 500.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-14
Primary completion date: 2019-07-04
Completion date: 2023-06-02
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).~For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).
Clinical trial NCT02578680: Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)
Official title: A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 616.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-15
Primary completion date: 2017-11-08
Completion date: 2023-06-22
Baseline population: The Baseline Analysis Population consisted of all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04244552: A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies
Official title: A Phase 1b Dose Escalation and Expansion Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Biological Activity of ATRC-101 as Monotherapy and in Combination With Other Anticancer Agents in Adults With Advanced Solid Malignancies
Sponsor: Atreca, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 87.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-02-11
Primary completion date: 2023-11-01
Completion date: 2023-11-01
Plan to share individual participant data: NO
Clinical trial NCT04489940: Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer
Official title: A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With HMGA2-expressing Triple Negative Breast Cancer
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was prematurely discontinued by the sponsor due to probability of success which was too low to justify the continuation of recruitment.
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-12
Primary completion date: 2022-01-27
Completion date: 2022-07-08
Baseline population: The Full analysis set (FAS) included all participants, who were administered at least one infusion of bintrafusp alfa.
Limitations and caveats: Based on sponsors decision for early termination of the study due to lack of probability to achieve interim data allowing expansion of this study.~Hence, analysis for efficacy, or biomarker were not performed.
Plan to share individual participant data: YES
IPD sharing description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
IPD time frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD access criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Clinical trial NCT04611958: Intraductal Liposomal Bupivacaine for Chronic Pancreatitis
Official title: Intraductal Liposomal Bupivacaine as a Therapeutic Trial to Determine the Contribution of Peripheral Versus Central Sensitization in the Pathogenesis of Pain in Chronic Pancreatitis- a Pilot and Feasibility Study
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: The FDA requirements for the IND are not feasible to complete.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-01
Primary completion date: 2021-07-01
Completion date: 2021-07-01
Plan to share individual participant data: NO
Clinical trial NCT04398290: iNOPulse for COVID-19
Official title: Randomized Controlled Trial Of A Delivered Continuously By Nasal Cannula For The Treatment Of Patients With COVID-19 And Mild To Moderate Hypoxemia Requiring Supplemental Oxygen
Acronym: NO-COVER
Sponsor: University of Miami (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: IRB AND FDA REVIEWS DEFERRED
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-01
Primary completion date: 2021-06-01
Completion date: 2021-07-15
Plan to share individual participant data: NO
Clinical trial NCT06417697: A Phase 1b Study to Evaluate the Safety of XEN-101
Official title: A Phase 1b, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Effects of XEN-101 on Safety, Tolerability, and Pharmacodynamics in Subjects with Obesity
Sponsor: Xeno Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study not stopped for safety reasons. Data were reviewed after the first 23 patients had completed scheduled dosing and there was no signal of efficacy for change in body weight. This clinical trial has been determined to be futile.
Enrollment: 33.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-05-24
Primary completion date: 2024-09-09
Completion date: 2024-09-09
Plan to share individual participant data: NO
Clinical trial NCT02303795: RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial
Official title: A Phase 2, Randomized, Open Label, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Rivaroxaban Compared With Vitamin K Antagonism in Patients With Atrial Fibrillation With Bioprosthetic Mitral Valves - RIVER
Sponsor: Hospital do Coracao (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 1005.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-08-31
Primary completion date: 2020-08-31
Completion date: 2020-08-31
Clinical trial NCT04969679: Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment.
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Mutaflor in Patients With Mild-to-moderate Ulcerative Colitis on 5-ASA Treatment.
Sponsor: Kangbuk Samsung Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 134.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-16
Primary completion date: 2020-06-03
Completion date: 2020-06-03