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identifier: FEvIR Object Identifier/179630, https://pubmed.ncbi.nlm.nih.gov/26092557

title: 26092557 Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non-castration-resistant prostate cancer.

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identifier: https://pubmed.ncbi.nlm.nih.gov/26092557, https://doi.org/10.1016/j.urolonc.2015.05.012, pii/S1078-1439(15)00235-5

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Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non-castration-resistant prostate cancer.

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BACKGROUND AND OBJECTIVE: Sequential tissue biopsies taken during clinical trials of novel systemic anticancer therapies for advanced prostate cancer (PCa) may aid pharmacodynamic evaluation and biomarker discovery. We conducted a single institution phase-II open-labeled randomized study to assess the safety, tolerability, and early efficacy of docetaxel chemotherapy plus androgen deprivation therapy (ADT) vs. ADT alone for patients with advanced non-castration-resistant PCa with sequential prostatic biopsies.\nPATIENTS AND METHODS: We randomized 30 patients with newly diagnosed high-grade locally advanced or metastatic (cT3-4/N0-1/M0-1) PCa to receive ADT with (n = 15) or without (n = 15) docetaxel. Transrectal ultrasound-guided prostatic biopsies were taken at randomization and ~22 weeks after treatment initiation. Primary end point: biochemical response rate. Secondary end points: time to progression and tumor profiling.\nRESULTS: Both treatments appear to be well tolerated, and there was no difference in mean nadir prostate-specific antigen and time to prostate-specific antigen relapse between treatment arms (P>0.05). No adverse effects of pre- and post-treatment prostatic biopsies were observed. The study was neither designed nor sufficiently powered to demonstrate statistically significant differences in oncological outcomes or safety profiles between the 2 treatment arms.\nCONCLUSIONS: Despite the lack of statistical power, our study suggests that docetaxel and ADT in combination may be well tolerated with apparently similar short-term efficacy compared with ADT alone for high-grade locally advanced or metastatic non-castration-resistant PCa, Sequential prostatic biopsies may provide tissue for tumor profiling to yield mechanistic or prognostic insights relating to novel systemic anticancer therapies.

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Copyright © 2015 Elsevier Inc. All rights reserved.

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identifier: Electronic ISSN Type/1873-2496, ISOAbbreviation/Urol Oncol, ISSN Linking/1078-1439, Medline Title Abbreviation/Urol Oncol, NLM Unique ID/9805460

title: Urologic oncology

publisherLocation: United States

citedMedium: Internet

volume: 33

issue: 8

articleDate: 2015-08

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contributor: Rajan P

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affiliation: Institute of Cancer Sciences, University of Glasgow, UK. Electronic address: p.rajan@beatson.gla.ac.uk.

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affiliation: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.

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affiliation: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.

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affiliation: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.

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contributor: McMenemin RM

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affiliation: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.

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affiliation: Institute of Cancer Sciences, University of Glasgow, UK.

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contributor: Soomro NA

forenameInitials: NA

affiliation: Newcastle Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.

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affiliation: Newcastle Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.

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affiliation: Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.

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contributor: Leung HY

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affiliation: Institute of Cancer Sciences, University of Glasgow, UK; Cancer Research UK Beatson Institute, Bearsden, UK. Electronic address: h.leung@beatson.gla.ac.uk.

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fhir:l ] ; fhir:code [ fhir:v "D043823" ] ; fhir:display [ fhir:v "Taxoids" ] ; fhir:userSelected [ fhir:v false ] ] ) ] ) ; fhir:freeToShare [ fhir:v true ] ; fhir:component ( [ fhir:type [ fhir:text [ fhir:v "qualifier" ] ] ; fhir:classifier ( [ fhir:text [ fhir:v "is not a major topic" ] ] ) ] [ fhir:type [ fhir:text [ fhir:v "qualifier" ] ] ; fhir:classifier ( [ fhir:coding ( [ a mesh:Q000008 ; fhir:system [ fhir:v "https://www.nlm.nih.gov/mesh"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "Q000008" ] ; fhir:display [ fhir:v "administration & dosage" ] ] ) ] ) ; fhir:component ( [ fhir:type [ fhir:text [ fhir:v "is Major topic" ] ] ; fhir:classifier ( [ fhir:coding ( [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "C49487" ] ; fhir:display [ fhir:v "No" ] ] ) ] ) ] ) ] [ fhir:type [ fhir:text [ fhir:v "qualifier" ] ] ; fhir:classifier ( [ fhir:coding ( [ a mesh:Q000627 ; fhir:system [ fhir:v "https://www.nlm.nih.gov/mesh"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "Q000627" ] ; fhir:display [ fhir:v "therapeutic use" ] ] ) ] ) ; fhir:component ( [ fhir:type [ fhir:text [ fhir:v "is Major topic" ] ] ; fhir:classifier ( [ fhir:coding ( [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "C49488" ] ; fhir:display [ fhir:v "Yes" ] ] ) ] ) ] ) ] ) ] ) ] ) ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:CodeableConcept ; fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "active" ] ; fhir:display [ fhir:v "Active" ] ] ) ] ] ) ; # fhir:url [ fhir:v "https://fevir.net/resources/Citation/179630"^^xsd:anyURI ; fhir:l ] ; # fhir:identifier ( [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "ACSN" ] ; fhir:display [ fhir:v "Accession ID" ] ] ) ; fhir:text [ fhir:v "FEvIR Object Identifier" ] ] ; fhir:system [ fhir:v "https://fevir.net/FOI"^^xsd:anyURI ; fhir:l ] ; fhir:value [ fhir:v "179630" ] ; fhir:assigner [ fhir:display [ fhir:v "Computable Publishing LLC" ] ] ] [ fhir:system [ fhir:v "https://pubmed.ncbi.nlm.nih.gov"^^xsd:anyURI ; fhir:l ] ; fhir:value [ fhir:v "26092557" ] ] ) ; # fhir:title [ fhir:v "26092557 Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non-castration-resistant prostate cancer."] ; # fhir:status [ fhir:v "active"] ; # fhir:author ( [ fhir:name [ fhir:v "Computable Publishing®: MEDLINE-to-FEvIR Converter" ] ] ) ; # fhir:publisher [ fhir:v "Computable Publishing LLC"] ; # fhir:contact ( [ fhir:telecom ( [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "support@computablepublishing.com" ] ] ) ] ) ; # fhir:description [ fhir:v "This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide."] ; # fhir:useContext ( [ fhir:code [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/citation-classification-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "fevir-platform-use" ] ; fhir:display [ fhir:v "FEvIR Platform Use" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/citation-artifact-classifier"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "medline-base" ] ; fhir:display [ fhir:v "Medline Base" ] ; fhir:userSelected [ fhir:v false ] ] ) ] ] ) ; # fhir:copyright [ fhir:v "https://creativecommons.org/licenses/by-nc-sa/4.0/"] ; # fhir:approvalDate [ fhir:v "2016-04-14"^^xsd:date] ; # fhir:lastReviewDate [ fhir:v "2024-02-10"^^xsd:date] ; # fhir:classification ( [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/citation-classification-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "citation-source" ] ; fhir:display [ fhir:v "Citation Source" ] ] ) ] ; fhir:classifier ( [ fhir:text [ fhir:v "MEDLINE" ] ] ) ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/citation-classification-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "medline-owner" ] ; fhir:display [ fhir:v "MEDLINE Citation Owner" ] ] ) ] ; fhir:classifier ( [ fhir:coding ( [ fhir:system [ fhir:v "https://www.nlm.nih.gov/bsd/licensee/elements_descriptions.html#owner_value"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "NLM" ] ; fhir:display [ fhir:v "National Library of Medicine, Index Section" ] ; fhir:userSelected [ fhir:v false ] ] ) ] ) ] ) ; # fhir:currentState ( [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/citation-status-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "medline-medline" ] ; fhir:display [ fhir:v "Medline Citation Status of Medline" ] ] ) ] [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/citation-status-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "pubmed-publication-status-ppublish" ] ; fhir:display [ fhir:v "PubMed PublicationStatus of ppublish" ] ] ) ] ) ; # fhir:statusDate ( [ fhir:activity [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/citation-status-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "pubmed-pubstatus-received" ] ; fhir:display [ fhir:v "PubMed Pubstatus of Received" ] ] ) ] ; fhir:period [ fhir:end [ fhir:v "2015-02-20"^^xsd:date ] ] ] [ fhir:activity [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/citation-status-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "pubmed-pubstatus-revised" ] ; fhir:display [ fhir:v "PubMed Pubstatus of Revised" ] ] ) ] ; fhir:period [ fhir:end [ fhir:v "2015-05-08"^^xsd:date ] ] ] [ fhir:activity [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/citation-status-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "pubmed-pubstatus-accepted" ] ; fhir:display [ fhir:v "PubMed Pubstatus of Accepted" ] ] ) ] ; fhir:period [ fhir:end [ fhir:v "2015-05-11"^^xsd:date ] ] ] [ fhir:activity [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/citation-status-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "pubmed-pubstatus-entrez" ] ; fhir:display [ fhir:v "PubMed Pubstatus of Entrez" ] ] ) ] ; fhir:period [ fhir:end [ fhir:v "2015-06-21T06:00:00.000Z"^^xsd:dateTime ] ] ] [ fhir:activity [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/citation-status-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "pubmed-pubstatus-pubmed" ] ; fhir:display [ fhir:v "PubMed Pubstatus of Pubmed" ] ] ) ] ; fhir:period [ fhir:end [ fhir:v "2015-06-21T06:00:00.000Z"^^xsd:dateTime ] ] ] [ fhir:activity [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/citation-status-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "pubmed-pubstatus-medline" ] ; fhir:display [ fhir:v "PubMed Pubstatus of Medline" ] ] ) ] ; fhir:period [ fhir:end [ fhir:v "2016-04-15T06:00:00.000Z"^^xsd:dateTime ] ] ] ) ; # fhir:citedArtifact [ fhir:identifier ( [ fhir:system [ fhir:v "https://pubmed.ncbi.nlm.nih.gov"^^xsd:anyURI ; fhir:l ] ; fhir:value [ fhir:v "26092557" ] ] [ fhir:system [ fhir:v "https://doi.org"^^xsd:anyURI ; fhir:l ] ; fhir:value [ fhir:v "10.1016/j.urolonc.2015.05.012" ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "ACSN" ] ; fhir:display [ fhir:v "Accession ID" ] ] ) ; fhir:text [ fhir:v "pii" ] ] ; fhir:value [ fhir:v "S1078-1439(15)00235-5" ] ] ) ; fhir:title ( [ fhir:type ( [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/title-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "primary" ] ; fhir:display [ fhir:v "Primary title" ] ] ) ] ) ; fhir:text [ fhir:v "Feasibility study of a randomized controlled trial comparing docetaxel chemotherapy and androgen deprivation therapy with sequential prostatic biopsies from patients with advanced non-castration-resistant prostate cancer." ] ] ) ; fhir:abstract ( [ fhir:type ( [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/cited-artifact-abstract-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "primary-human-use" ] ; fhir:display [ fhir:v "Primary human use" ] ] ) ] ) ; fhir:text [ fhir:v "**BACKGROUND AND OBJECTIVE:** Sequential tissue biopsies taken during clinical trials of novel systemic anticancer therapies for advanced prostate cancer (PCa) may aid pharmacodynamic evaluation and biomarker discovery. We conducted a single institution phase-II open-labeled randomized study to assess the safety, tolerability, and early efficacy of docetaxel chemotherapy plus androgen deprivation therapy (ADT) vs. ADT alone for patients with advanced non-castration-resistant PCa with sequential prostatic biopsies.\n**PATIENTS AND METHODS:** We randomized 30 patients with newly diagnosed high-grade locally advanced or metastatic (cT3-4/N0-1/M0-1) PCa to receive ADT with (n = 15) or without (n = 15) docetaxel. Transrectal ultrasound-guided prostatic biopsies were taken at randomization and ~22 weeks after treatment initiation. Primary end point: biochemical response rate. Secondary end points: time to progression and tumor profiling.\n**RESULTS:** Both treatments appear to be well tolerated, and there was no difference in mean nadir prostate-specific antigen and time to prostate-specific antigen relapse between treatment arms (P>0.05). No adverse effects of pre- and post-treatment prostatic biopsies were observed. The study was neither designed nor sufficiently powered to demonstrate statistically significant differences in oncological outcomes or safety profiles between the 2 treatment arms.\n**CONCLUSIONS:** Despite the lack of statistical power, our study suggests that docetaxel and ADT in combination may be well tolerated with apparently similar short-term efficacy compared with ADT alone for high-grade locally advanced or metastatic non-castration-resistant PCa, Sequential prostatic biopsies may provide tissue for tumor profiling to yield mechanistic or prognostic insights relating to novel systemic anticancer therapies." ] ; fhir:copyright [ fhir:v "Copyright © 2015 Elsevier Inc. All rights reserved." ] ] ) ; fhir:publicationForm ( [ fhir:publishedIn [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/published-in-type"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "D020492" ] ; fhir:display [ fhir:v "Periodical" ] ] ) ] ; fhir:identifier ( [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "https://www.nlm.nih.gov/bsd/licensee/elements_descriptions.html#issn"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "Electronic" ] ; fhir:display [ fhir:v "Electronic" ] ] ) ; fhir:text [ fhir:v "Electronic ISSN Type" ] ] ; fhir:system [ fhir:v "https://portal.issn.org"^^xsd:anyURI ; fhir:l ] ; fhir:value [ fhir:v "1873-2496" ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "XX" ] ; fhir:display [ fhir:v "Organization identifier" ] ] ) ; fhir:text [ fhir:v "ISOAbbreviation" ] ] ; fhir:system [ fhir:v "https://www.issn.org/services/online-services/access-to-the-ltwa/"^^xsd:anyURI ; fhir:l ] ; fhir:value [ fhir:v "Urol Oncol" ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "XX" ] ; fhir:display [ fhir:v "Organization identifier" ] ] ) ; fhir:text [ fhir:v "ISSN Linking" ] ] ; fhir:system [ fhir:v "https://www.issn.org/understanding-the-issn/assignment-rules/the-issn-l-for-publications-on-multiple-media/"^^xsd:anyURI ; fhir:l ] ; fhir:value [ fhir:v "1078-1439" ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "XX" ] ; fhir:display [ fhir:v "Organization identifier" ] ] ) ; fhir:text [ fhir:v "Medline Title Abbreviation" ] ] ; fhir:system [ fhir:v "https://www.nlm.nih.gov/tsd/cataloging/contructitleabbre.html"^^xsd:anyURI ; fhir:l ] ; fhir:value [ fhir:v "Urol Oncol" ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "XX" ] ; fhir:display [ fhir:v "Organization identifier" ] ] ) ; fhir:text [ fhir:v "NLM Unique ID" ] ] ; fhir:system [ fhir:v "https://locatorplus.gov/cgi-bin/Pwebrecon.cgi?DB=local"^^xsd:anyURI ; fhir:l ] ; fhir:value [ fhir:v "9805460" ] ] ) ; fhir:title [ fhir:v "Urologic oncology" ] ; fhir:publisherLocation [ fhir:v "United States" ] ] ; fhir:citedMedium [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/cited-medium"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "internet" ] ; fhir:display [ fhir:v "Internet" ] ] ) ] ; fhir:volume [ fhir:v "33" ] ; fhir:issue [ fhir:v "8" ] ; fhir:articleDate [ fhir:v "2015-08"^^xsd:gYearMonth ] ; fhir:pageString [ fhir:v "337.e1-6" ] ] [ fhir:citedMedium [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/cited-medium"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "internet-without-issue" ] ; fhir:display [ fhir:v "Internet without issue" ] ] ) ] ; fhir:articleDate [ fhir:v "2015-06-16"^^xsd:date ] ] ) ; 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Electronic address: h.leung@beatson.gla.ac.uk." ] ] ) ] ) ] ] . # # -------------------------------------------------------------------------------------