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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41231   clinical trials with a EudraCT protocol, of which   6758   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2017-000292-83
    Sponsor's Protocol Code Number:Tallisur
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-06-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2017-000292-83
    A.3Full title of the trial
    Prospective, Multicenter, Open-label Phase IV trial of Trifluridine/Tipiracil to Evaluate the Health-related Quality of Life in Patients with Metastatic Colorectal Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective, Multicenter, Open-label Phase IV trial of Trifluridine/Tipiracil to Evaluate the Health-related Quality of Life in Patients with Metastatic Colorectal Cancer
    A.3.2Name or abbreviated title of the trial where available
    Trifluridine/tripiracil quality of life study in mCRC patients
    A.4.1Sponsor's protocol code numberTallisur
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorServier Deutschland GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportServier Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationServier Deutschland GmbH
    B.5.2Functional name of contact pointPD Dr. Jürgen Hess
    B.5.3 Address:
    B.5.3.1Street AddressElsenheimerstraße 53
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code80687
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 (0)89 570 95 264
    B.5.5Fax number+49(0)89 570 95274
    B.5.6E-mailjuergen.hess@servier.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lonsurf
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoires Servier, Frankreich
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIFLURIDINE
    D.3.9.3Other descriptive nameTRIFLURIDINE
    D.3.9.4EV Substance CodeSUB11291MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIPIRACIL
    D.3.9.3Other descriptive nameTIPIRACIL
    D.3.9.4EV Substance CodeSUB174128
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.14
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lonsurf
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoires Servier, Frankreich
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIFLURIDINE
    D.3.9.3Other descriptive nameTRIFLURIDINE
    D.3.9.4EV Substance CodeSUB11291MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIPIRACIL
    D.3.9.3Other descriptive nameTIPIRACIL
    D.3.9.4EV Substance CodeSUB174128
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8.19
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Histologically or cytologically confirmed UICC stage IV carcinoma of colon or rectum with metastasis (metastatic colorectal cancer) with need for treatment due to progression
    E.1.1.1Medical condition in easily understood language
    metastatic colorectal cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of treatment with FTD/TPI on HRQoL as measured by EORTC QLQ-C30 (global health status/quality of life scale)
    E.2.2Secondary objectives of the trial
    • To assess HRQoL measured by the EORTC QLQ-C30 (all scales and items) and the EQ-5D-5L questionnaire under FTD/TPI and under BSC
    • To evaluate time-to event measures under treatment with FTD/TPI and in those only being observed and given BSC
    • To evaluate safety of treatment with FTD/TPI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients had provided written informed consent prior to any procedure
    • Patients of ≥ 18 years of age at the time of signing the informed consent
    • Histologically or cytologically confirmed UICC stage IV carcinoma of colon or rectum with metastasis (metastatic colorectal cancer) with need for treatment due to progression
    • At least one measurable or non-measurable lesion as defined by RECIST version 1.1 32
    • Patients who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents
    • Patients able to take medications orally (ie, no feeding tube)
    • mCRC patients independent from their ECOG performance status at study enrolment
    • Adequate organ function as defined by the following laboratory values obtained within 7 days prior to first administration of FTD/TPI on Day 1 of Cycle 1 (haematology and laboratory values for patients who are administered only BSC need not be obtained within 7 days prior to observation Cycle 1)
    a. Absolute neutrophil count of ≥ 1.5 × 109/L,
    b. Platelet count ≥ 75 × 109/L,
    c. Total serum bilirubin of ≤ 1.5 upper limit of normal (ULN),
    d. Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3.0 × ULN; if liver function abnormalities are due to underlying liver metastasis, AST and ALT ≤ 5 × ULN
    e. Calculated creatinine clearance (CrCl) ≥ 30 mL/min
    • Only applicable for females who receive treatment with FTD/TPI (Group A):
    Females of childbearing potential (FCBPs) must have a negative pregnancy test (urine or serum) within 7 days prior to enrolment. FCBPs must agree to use highly effective contraceptive measures with a failure rate of less than 1% per year when used consistently and correctly as defined in Section 4.1 of the CTFG guidance “Recommendations related to contraception and pregnancy testing in clinical trials” during the entire study treatment with FTD/TPI and up to 6 months after the discontinuation of study drug FTD/TPI. Complete sexual abstinence is acceptable as a highly effective contraceptive method only if the subject is refraining from heterosexual intercourse during the entire study treatment with FTD/TPI and up to 6 months after the discontinuation of study drug FTD/TPI and the reliability of sexual abstinence is in line with the preferred and usual lifestyle of the subject.
    Women using hormonal contraceptives should agree to add a barrier contraceptive method.
    A woman will be considered as being of childbearing potential unless she has gone through menopause for at least 1 year (i.e. minimum of one year without menses) or unless she has a history of tubal ligation, bilateral oophorectomy or hysterectomy that is clearly documented in the patient’s source documents.
    • Only applicable for males who receive treatment with FTD/TPI (Group A):
    Males must agree to use effective contraceptive measures or to practice complete abstinence during the study treatment with FTD/TPI and up to 6 months after the discontinuation of study drug FTD/TPI
    • Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study, who are able to understand and to fill in the questionnaire and from whom written and dated informed consent to participate in the study has been obtained.
    E.4Principal exclusion criteria
    • Patients requesting not to be treated with FTD/TPI but considering other tumour treatment (e.g. palliative radiotherapy)
    • Concurrently active malignancies other than mCRC excluding malignancies that are disease free for more than 5 years, adequately treated basal cell or squamous cell skin cancer or carcinoma-in-situ deemed cured by adequate treatment, e.g. in situ cervical, breast or prostate cancer.
    • Brain or leptomeningeal metastases not controlled through surgery or radiotherapy
    • Active infection (i.e, body temperature ≥38°C due to infection)
    • Intestinal obstruction
    • Uncontrolled diarrhea
    • Uncontrolled diabetes
    • Pulmonary fibrosis or interstitial pneumonitis
    • Renal failure with CrCl <30 ml/min
    • Hepatic failure ≥ CTCAE version 4 Grade 3
    • Cerebrovascular accident within the last 6 months
    • Myocardial infarction within the last 6 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
    • Gastrointestinal hemorrhage within last 3 months
    • Autoimmune disorders or history of organ transplantation that require immunosuppressive therapy.
    • Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the generation of QoL results.
    • Any other severe concomitant disease or disorder, including the presence of laboratory abnormalities, which places the subject at unacceptable risk or which could influence patient’s ability to participate in the study and his/her safety during the study or interfere with interpretation of study results
    • Treatment with any of the following within the specified time frame prior to first administration of FTD/TPI or Day 1 of observation cycle 1 (if no administration of FTD/TPI):
    a. Major surgery within prior 4 weeks (the surgical incision should be fully healed prior to study drug administration).
    b. Any anticancer therapy within prior 2 weeks.
    c. Extended field radiation within prior 4 weeks or limited field radiation within prior 2 weeks.
    • Participation in any other clinical trial or treatment with any experimental drug or other experimental therapy within 28 days prior to first administration of FTD/TPI or Day 1 of observation cycle 1 (if no administration of FTD/TPI); participation in a non-interventional study is permitted.
    • Patients who have already received FTD/TPI
    • Unresolved non-haematological toxicity of ≥ CTCAE version 4 Grade III attributed to prior therapies excluding anemia, alopecia, skin pigmentation and platinum induced neurotoxicity
    • Hypersensitivity to trifluridine, tipiracil or any of the excipients
    • Hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
    • Pregnant or breast-feeding female
    • Inappropriate for entry into this study in the judgment of the investigator
    • Patient has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
    • Patients possibly dependent from the investigator including the spouse, children and close relatives of any investigator
    E.5 End points
    E.5.1Primary end point(s)
    Rate of responders with continued unchanged or improved HRQoL.
    Response is calculated as mean of the score of the EORTC QLQ-C30, global health status/quality of life scale [QL2] at all scheduled time points of QoL analysis in the time interval from two days before start of Cycle 2 until the end of treatment /end of close observation compared to the baseline score of the global health status /quality of life scale.
    Response will be defined as improvement (≥ 10 scores) or stabilization (> -10 and < 10 scores) compared to the baseline score of the global health status/quality of life scale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - day 1 of each treatment cycle bevor Administration of FTD/TPI / start o the observation cycle
    - end of treatment visit/ end of close observation
    - month 1-6 of Follow-up, therafter after month 9 and 12 follow-up for a max. Duration of 1 year after the date od first application of FTD/TPI or cycle 1 D1 of close observation (exception: questioning with EORTC QLQ-30 and EQ-5D-5L of patients who receive FTD/TPI treatment for more than 1 year (Group A) for the duration of treatment as described above, at the end-of-treatment visit and at Month 1 of follow up).
    E.5.2Secondary end point(s)
    Quality of life
    • Rate of responders in the QoL analysis (measured by the EORTC QLQ-C30, global health status/quality of life scale) at every scheduled time point for EORTC QLQ-C30 separately in the time interval from two days before start of Cycle 2 until the end of treatment/end of close observation, at every time point compared to the baseline score of the global health status/quality of life scale.
    Response will be defined as improvement (≥ 10 scores) or stabilization (> -10 and < 10 scores) compared to the baseline score of the global health status/quality of life scale at the specified time point.
    • HRQoL analysis measured by the EORTC QLQ-C30 questionnaire (all scales/single items; all time points from baseline until end of follow up)
    • HRQoL analysis measured by the questionnaire EQ-5D-5L descriptive system; all time points from baseline until end of follow up
    • Scores of the EQ VAS as a measure of overall self-rated health status compared to baseline EQ VAS score; all time points until end of follow up
    • Time to health-related QoL deterioration measured by EORTC QLQ-C30; global health status/quality of life scale; deterioration defined as a first change of score to < -10 compared to baseline score
    • Time to health-related QoL deterioration measured by EQ VAS score; deterioration compared to baseline VAS score
    • Disease-specific symptoms of the mCRC measured by the respective subdomains of the EORTC QLQ-C30 (symptom scales fatigue, nausea and vomiting, appetite loss, pain, dyspnoea, constipation, diarrhoea)
    • HRQoL analysis measured by the EORTC QLQ-C30 questionnaire (all scales/single items; all time points from baseline until follow up, analysis of response) for following comparisons (if applicable):
    • During treatment/close observation vs. after treatment/close observation
    • Treatment with FTD/TPI vs. close observation with BSC
    • During treatment/close observation (patients with 2 cycles) vs. during treatment/close observation (patients with < 2 cycles and early progression in Cycle 1)
    • HRQoL analysis measured by the questionnaire EQ-5D-5L and the EQ VAS (all timepoints from baseline to follow up) for following comparisons (if applicable):
    - During treatment/close observation vs. after treatment/close observation
    - Treatment with FTD/TPI vs. close observation with BSC
    - During treatment/close observation (patients with < 2 cycles) vs. during treatment/close observation (patients with < 2 cycles and early progression in Cycle 1)

    Efficacy
    • Progression-free survival (clinical or radiological progression) [PFS]
    • Overall survival ([OS], calculated from start of treatment/close observation on study)
    • Exploratory analysis of objective response rate (ORR)

    Safety
    • Type, incidence, and severity of FTD/TPI-related adverse reactions (severity evaluated according to CTCAE version 4)
    • Tumour-related symptoms and adverse events
    • Treatment duration/exposure to FTD/TPI (Group A)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Quality of life:
    - day 1 of each treatment cycle bevor Administration of FTD/TPI / start o the observation cycle
    - end of treatment visit/ end of close observation
    - month 1-6 of Follow-up, therafter after month 9 and 12 follow-up for a max. Duration of 1 year after the date od first application of FTD/TPI or cycle 1 D1 of close observation (exception: questioning with EORTC QLQ-30 and EQ-5D-5L of patients who receive FTD/TPI treatment for more than 1 year (Group A) for the duration of treatment as described above, at the EOT-Visit and at Month 1 of follow up).

    Efficacy:
    - Restaging: after every second treatment / observation cycle, end of treatment/Observation, Follow-up
    - monthly

    Safety:
    - monthly
    - end of treatment visit/ end of close observation
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned45
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state195
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Best standard care available as judged by the treating physician.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
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