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221. Evolocumab - benefit assessment according to §35a Social Code Book V

in Health Care (IQWiG) - I.v - List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy CHD coronary heart disease EMA European Medicines Agency G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) LDL-C low-density lipoprotein cholesterol PAOD peripheral arterial occlusive disease SGB Sozialgesetzbuch (Social Code Book) SPC Summary of Product (...) Evolocumab - benefit assessment according to §35a Social Code Book V Extract 1 Translation of Assessment module I, Sections I 2.1 to I 2.6, and Assessment module II, Sections II 2.1 to II 2.5, of the dossier assessment Evolocumab – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 December 2015). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

222. Aclidinium/formoterol: benefit assessment according to §35a Social Code Book V (dossier assessment)

. Institute for Quality and Efficiency in Health Care. General Methods: version 4.1 [online]. 28 November 2013 [accessed: 1 February 2015]. URL: https://www.iqwig.de/download/IQWiG_General_Methods_Version_%204-1.pdf. 2. Institute for Quality and Efficiency in Health Care. Ticagrelor: benefit assessment according to §35a Social Code Book V; extract; commission no. A11-02 [online]. 29 September 2011 [accessed: 5 May 2012]. URL: https://www.iqwig.de/download/A11 (...) Aclidinium/formoterol: benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Aclidiniumbromid/Formoterol – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 April 2015). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A15-06

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

223. Dasabuvir: benefit assessment according to §35a Social Code Book V (dossier assessment)

Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A15-03 Version 1.0 Dasabuvir – Benefit assessment acc. to §35a Social Code Book V 29 April 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Christoph F. Dietrich, Caritas Hospital Bad Mergentheim (...) Dasabuvir: benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Dasabuvir – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 April 2015). Please note: This translation is provided as a service by IQWiG to English- language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A15-03 Dasabuvir – Benefit assessment

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

224. Ombitasvir/paritaprevir/ritonavir: benefit assessment according to §35a Social Code Book V (dossier assessment)

Ombitasvir/paritaprevir/ritonavir: benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.8 of the dossier assessment Ombitasvir/Paritaprevir/Ritonavir – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 April 2015). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A15-04 Ombitasvir/paritaprevir/ ritonavir – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-04 Version 1.0 Ombitasvir/paritaprevir/ritonavir – Benefit assessment acc. to §35a SGB V 29 April 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ombitasvir/paritaprevir/ritonavir – Benefit assessment according to §35a Social Code Book V

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

225. Insulin degludec/liraglutide: benefit assessment according to §35a Social Code Book V (dossier assessment)

Insulin degludec/liraglutide: benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Insulin degludec/Liraglutid – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 July 2015). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A15-15 (...) Insulin degludec/liraglutide – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-15 Version 1.0 Insulin degludec/liraglutide – Benefit assessment acc. to §35a SGB V 30 July 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Insulin degludec/liraglutide – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

226. Afatinib: benefit assessment according to §35a Social Code Book V (dossier assessment)

of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A15-17 Version 1.0 Afatinib – Benefit assessment acc. to §35a Social Code Book V 13 August 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Ingo Schmidt-Wolf, Centre for Integrated Oncology (CIO), Bonn (...) - up visit). ECOG PS: Eastern Cooperative Oncology Group Performance Status; RCT: randomized controlled trial; vs.: versus Extract of dossier assessment A15-17 Version 1.0 Afatinib – Benefit assessment acc. to §35a Social Code Book V 13 August 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - 16 - The data of all patients were included in the analysis of overall survival also after discontinuation of the study medication and possible treatment switching. The recording of other data

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

227. Dulaglutide: benefit assessment according to §35a Social Code Book V (dossier assessment)

No.: A15-07 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A15-07 Version 1.0 Dulaglutide – Benefit assessment acc. to §35a Social Code Book V 29 April 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Andreas Barthel, Endokrinologikum Ruhr (...) Blood Sugar Survey LOCF last observation carried forward MedDRA Medical Dictionary for Regulatory Activities MMRM mixed-effects model repeated measures NVL Nationale VersorgungsLeitlinie (National Care Guideline) OAD oral antidiabetic PT Preferred Term RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SOC System Organ Class SPC Summary of Product Characteristics VAS visual analogue scale Extract of dossier assessment A15-07 Version 1.0 Dulaglutide

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

228. Nintedanib - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A15-01 Version 1.0 Nintedanib – Benefit assessment acc. to §35a Social Code Book V 30 March 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Marcus Wiedmann, Department of Internal Medicine I, St (...) treatment cycle ? Dose reduction scheme: ? Placebo and docetaxel: dose reduction as in the intervention arm Concomitant medication ? medications or treatments for adequate patient care may be given if clinically necessary ? bisphosphonates in bone metastases ? non-oncological treatments including alternative and/or complementary medicine (vitamins, dietary supplements, anaesthetics), palliative radiotherapy for symptom control (in bone metastases in the extremities) ? oral corticosteroid (e.g

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

229. Secukinumab: benefit assessment according to §35a Social Code Book V (dossier assessment)

No.: A15-20 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A15-20 Version 1.0 Secukinumab – Benefit assessment acc. to §35a Social Code Book V 28 August 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Michael Weichenthal, University Medical (...) Secukinumab: benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Secukinumab – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 August 2015). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A15-20 Secukinumab – Benefit

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

230. Lomitapide: benefit assessment according to §35a Social Code Book V (dossier assessment)

No.: A15-23 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A15-23 Version 1.0 Lomitapide – Benefit assessment acc. to §35a Social Code Book V 10 September 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Manfred Gogol, Lindenbrunn Hospital (...) assessment A15-23 Version 1.0 Lomitapide – Benefit assessment acc. to §35a Social Code Book V 10 September 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - 13 - cardiovascular events. The European regulatory authority (European Medicines Agency [EMA]) also referred to the lowering of LDL-C levels as a surrogate endpoint in its assessment report of lomitapide, and noted that the recording of data on cardiovascular events is a condition to the marketing authorization of lomitapide [21

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

231. Safinamide: benefit assessment according to §35a Social Code Book V (dossier assessment)

Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A15-18 Version 1.0 Safinamide – Benefit assessment acc. to §35a Social Code Book V 13 August 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Rüdiger Mielke, Chair of Neuroscience (...) , but the publications are from the years 1996 to 2003. Additional relevant entacapone study BIA-91067-301 Based on the available information, the BIA-91067-301 study is also generally comparable to the available studies in its patient characteristics and inclusion and exclusion criteria. As in Extract of dossier assessment A15-18 Version 1.0 Safinamide – Benefit assessment acc. to §35a Social Code Book V 13 August 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - 10 - the other studies, patients

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

232. Belatacept: benefit assessment according to § 35a Social Code Book V (dossier assessment)

No.: A15-25 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A15-25 Version 1.0 Belatacept – Benefit assessment acc. to §35a Social Code Book V 13 October 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Reinhart T. Grundmann, District Hospitals (...) assessment acc. to §35a Social Code Book V 13 October 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - 9 - Table 5: Characteristics of the interventions – RCT, direct comparison: belatacept vs. ciclosporin A Study Belatacept Ciclosporin A Prior and concomitant medication BENEFIT Month 0–3: belatacept 10 mg/kg IV on days 1, 5 and in weeks 2, 4, 8 and 12 From month 4: belatacept 5 mg/kg IV every 4 weeks Daily starting dose: ciclosporin A oral 7 ± 3 mg/kg (4–10 mg/kg) Month 1: dose

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

233. Albiglutide - Benefit assessment according to §35a Social Code Book V (dossier assessment)

No.: A14-36 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A14-36 Version 1.0 Albiglutide – Benefit assessment acc. to §35a Social Code Book V 23 December 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Andreas Barthel, Endokrinologikum Ruhr (...) ACT appropriate comparator therapy AE adverse event BMI body mass index DPP-4 dipeptidyl peptidase 4 G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) GLP-1 glucagon-like-peptide 1 HbA1c glycosylated haemoglobin A1c IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) MedDRA Medical Dictionary for Regulatory Activities RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

234. Sucroferric oxyhydroxide - Benefit assessment according to §35a Social Code Book V (dossier assessment)

October 2014]. URL: http://www.fachinfo.de. 4. European Medicines Agency. Velphoro: European public assessment report; product information [German] [online]. 13 October 2014 [accessed: 6 November 2014]. URL: http://www.ema.europa.eu/docs/de_DE/document_library/EPAR_- _Product_Information/human/002705/WC500175254.pdf. 5. Genzyme. Renvela 800 mg Filmtabletten: Fachinformation [online]. March 2014 [accessed: 13 November 2014]. URL: http://www.fachinfo.de. 6. Vifor Fresenius Medical Care Renal Pharma (...) Sucroferric oxyhydroxide - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Sucroferric Oxyhydroxid – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 December 2014). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A14-37

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

235. Dolutegravir/abacavir/lamivudine - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Dolutegravir/abacavir/lamivudine - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Dolutegravir/Abacavir/Lamivudin – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 18 December 2014). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A14-34 Dolutegravir/abacavir/ lamivudine – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-34 Version 1.0 Dolutegravir/abacavir/lamivudine – Benefit assessment acc. to §35a SGB V 18 Dec 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dolutegravir/abacavir/lamivudine – Benefit assessment according to §35a SGB V Commissioning agency

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

236. Lurasidone - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A14-42 Version 1.0 Lurasidone – Benefit assessment acc. to §35a Social Code Book V 28 January 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Rüdiger Mielke, Chair of Neuroscience (...) daily dose; effect estimate: mean difference .. 16 Extract of dossier assessment A14-42 Version 1.0 Lurasidone – Benefit assessment acc. to §35a Social Code Book V 28 January 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - vi - List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy AE adverse event BAS Barnes Akathisia Scale CGI-S Clinical Global Impression Scale of Severity CI confidence interval EMA European Medicines Agency G-BA Gemeinsamer

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

237. Simoctocog alfa - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Internal Commission No.: A14-41 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A14-41 Version 1.0 Simoctocog alfa – Benefit assessment acc. to §35a Social Code Book V 11 February 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Bernd Pötzsch (...) – extent and probability of added benefit 6 3 Table numbers start with “2” as numbering follows that of the full dossier assessment. Extract of dossier assessment A14-41 Version 1.0 Simoctocog alfa – Benefit assessment acc. to §35a Social Code Book V 11 February 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - v - List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy EMA European Medicines Agency G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

238. Vildagliptin - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Commission No.: A14-46 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A14-46 Version 1.0 Vildagliptin – Benefit assessment acc. to §35a Social Code Book V 25 February 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Andreas Fritsche, Tübingen (...) European Medicines Agency G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) HbA1c glycosylated haemoglobin A1c IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) IU international units NPH neutral protamine Hagedorn SGB Sozialgesetzbuch (Social Code Book) Extract of dossier assessment A14-46 Version 1.0 Vildagliptin – Benefit assessment acc. to §35a Social Code Book V 25 February 2015 Institute for Quality and Efficiency

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

239. Sipuleucel-T - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Commission No.: A14-38 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A14-38 Version 1.0 Sipuleucel-T – Benefit assessment acc. to §35a Social Code Book V 23 December 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Gerhard Jakse, Rhine (...) of sipuleucel-T, particularly regarding the different subsequent therapies on disease progression and the lack of differences in progression-free survival between the study arms. This led to a deviating vote from some of the members of the Committee for Medicinal Products for Human Use (CHMP). Extract of dossier assessment A14-38 Version 1.0 Sipuleucel-T – Benefit assessment acc. to §35a Social Code Book V 23 December 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 3 - Mortality Overall

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

240. Idelalisib - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Idelalisib - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Assessment module I, Sections I 2.1 to I 2.9, and Assessment module II, Sections II 2.1 to II 2.6, of the dossier assessment Idelalisib – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 December 2014). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative (...) and legally binding. IQWiG Reports – Commission No. A14-35 Idelalisib – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-35 Version 1.0 Idelalisib – Benefit assessment acc. to §35a Social Code Book V 22 December 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Idelalisib – Benefit assessment according to §35a Social Code Book V Commissioning agency

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

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