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ICON PLC
ICON PLC
from Wikipedia

ICON plc is an Irish headquartered multinational healthcare intelligence and clinical research organisation.[1] As of February 2025 had approximately 41,900 employees in 55 countries.[2]

Key Information

History

[edit]

ICON was founded in Dublin, Ireland, by John Climax and Ronan Lambe in 1990.[3] Since January 2010, Climax has held a position on the board of directors. Lambe retired from the board of directors in 2018.[4]

Between 1991 and 1996, ICON opened offices in the United Kingdom, United States, Germany, and Japan.[5] Two years later, ICON shares started to be traded on Nasdaq.[6]

In March 2017, Steve Cutler was appointed Chief Executive Officer of ICON.[7] He had previously been with Quintiles South Africa, Sandoz AG, and Kendle Intl Inc, before joining ICON Clinical Research Services in 2011, and becoming Chief Operating Officer in 2014.[8]

In 2018, ICON won PharmaTimes Clinical Researcher of the Year.[9] In 2021, ICON was awarded PharmaTimes Clinical Research Company of the Year,[10] and in 2022, won Best Contract Research Organisation (FSP) [11] at the Scrip Awards.

On September 4, 2025, ICON announced that Steve Cutler will step down as CEO following his retirement on 1 October 2025 and is to be replaced by Chief Operating Officer Barry Balfe. [12]

Acquisitions

[edit]
  • 2000: ICON acquired UK-based regulatory consultancy, YRCR Ltd.; Central Laboratory in New York; and bioanalytical consultancy, Pacific Research[13][14][15]
  • 2002: ICON acquired clinical research provider, BPA.[16]
  • 2003: ICON acquired Medeval, a UK-based Phase I facility, and US consulting firm, Globomax [17][18]
  • 2004: ICON acquired medical imaging specialist, Beacon Bioscience Inc.[19]
  • 2006: ICON acquired outcomes research and health economics specialist, Ovation Research Group[20]
  • 2007: ICON acquired European staffing group, DOCS International[21]
  • 2008: ICON acquired US phase I provider, Healthcare Discoveries and US bioanalytical lab, Prevalere Life Sciences[22][23]
  • 2009: ICON acquired Veeda Laboratories, a UK biomarker lab[24]
  • 2010: ICON acquired Timaq Medical Imaging Inc.[25]
  • 2011: ICON acquired Oxford Outcomes, an international health outcomes consultancy and Firecrest Clinical, a technology provider specialising in site performance and study management[26][27]
  • 2012: ICON acquired PriceSpective, a global value strategy consultancy and Chinese CRO, BeijingWits[28][29]
  • 2013: ICON acquired staffing and FSP providers, ClinForce and Assent and Akos, an EU provider of pharmacovigilance and drug safety services[30][31]
  • 2014: ICON acquired Aptiv Solutions, a market leader in adaptive trial design and execution[32]
  • 2015: ICON acquired MediMedia Pharma Solutions to enhance market access and scientific communications capabilities, and PMG Research Inc., an integrated network of clinical research sites in the US[33][34]
  • 2016: ICON acquired Clinical Research Management Inc., to extend its presence in the government-sponsored research market[35]
  • 2017: ICON acquired MAPI Group, thereby becoming the world’s second-largest provider of late-phase services[36]
  • 2019: ICON acquired Symphony Clinical Research, a leading provider of at-home patient services and site-support services; MediNova, an integrated network of clinical research sites across EMEA; and MolecularMD, to enhance its laboratory offerings in molecular diagnostic testing and immunohistochemistry[37][38][39]
  • 2020: ICON acquired MedPass International, a leading European medical device CRO, regulatory and reimbursement consultancy[40]
  • 2021: ICON acquired PRA Health Sciences, a competitor offering clinical research services, for USD 12 billion. Upon completion of the transaction, PRA shareholders will own approximately 34 percent of the shares of the combined company and ICON shareholders will own approximately 66 percent.[41][42]

Finances

[edit]
Year Revenue
(in thousands USD)
Net Income
(in thousands USD)
Total Assets
(in thousands USD)
Employees
(k)
2020[43] 2,797,288 332,964 3,435,606 15,730
2021[44] 5,480,826 153,185 17,387,090 38,330
2022[45] 7,741,386 505,304 17,185,278 41,100
2023[46] 8,120,176 612,335 16,989,863 41,100
2024[47] 8,281,676 705,051 16,877,678 41,900

See also

[edit]

References

[edit]
[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia
from Grokipedia
ICON plc is an Irish-headquartered multinational (CRO) publicly traded on (ICLR), founded in 1990 in , , that provides outsourced clinical development—including integrated laboratory and assay development services through its Specialty Laboratories, Advanced Diagnostics Division, and global central laboratories—consulting, and services to the pharmaceutical, , , and / sectors. With a focus on accelerating and device development through innovative technologies and healthcare intelligence, ICON supports clients across the full product lifecycle, from early-phase trials to post-approval commercialization, leveraging its laboratory capabilities to support precision medicine and advanced clinical trials. As of September 30, 2025, the company employs approximately 39,800 people across 95 locations in 55 countries, delivering services worldwide. Established initially with a small team of five, ICON has grown into one of the world's leading CROs, emphasizing efficiency, quality, and reduced time-to-market for therapies. The company integrates expertise in various therapeutic areas with advanced AI-driven solutions to enhance outcomes, and it has been recognized with multiple industry awards for its contributions to innovation and ESG initiatives through programs like ICON Cares. In 2024, ICON reported revenue of $8,281.7 million, reflecting a 2.0% increase, alongside net business wins of $9,974 million. Its global network enables comprehensive support for complex, multinational clinical trials and regulatory submissions, positioning it as a key partner in advancing healthcare innovations.

History

Founding and early development

ICON plc was founded in June 1990 in , , by Dr. John Climax and Dr. Ronan Lambe, who had previously worked together at a research institute before establishing the company with a small initial team of five employees. The founders, both experienced in clinical research, aimed to address the growing need for specialized support in drug development amid increasing regulatory demands in the pharmaceutical sector. From its inception, ICON focused on providing outsourced and development services to pharmaceutical and companies, emphasizing full-service solutions for s and . Operating initially from modest offices in , the company offered expertise in areas such as management and data processing, helping clients navigate the complexities of bringing new therapies to market. This targeted approach positioned ICON as a reliable partner in an industry undergoing rapid evolution due to global harmonization efforts like the International Conference on Harmonization. Throughout the , ICON achieved steady internal growth, expanding its employee numbers and broadening its service capabilities to include more comprehensive support. By the late , the company had built a solid foundation in Ireland, with its workforce growing to support an increasing portfolio of projects for international clients. This period of development established key operational strengths that facilitated later international efforts.

International expansion and public listing

Following its founding in , , in 1990, ICON PLC began expanding internationally to support its growing operations across key global markets. In 1991, the company established its first overseas office in Winchester, , to facilitate European client engagements. This was followed by the opening of its initial U.S. office in in 1992, enabling access to the largest pharmaceutical market. By 1995, ICON had opened an office in , strengthening its presence in , and in 1996, it entered the Asian market with an office in , , to address regional regulatory and trial needs. To sustain these multi-country operations, ICON experienced significant initial employee growth, increasing from a team of five in 1990 to approximately 500 employees worldwide by 1998. This expansion in workforce was essential for managing cross-border clinical trials, , and across diverse geographies. In May 1998, ICON transitioned to a publicly traded with its initial public offering on the under the ICLR, raising capital to fuel further growth and marking a pivotal shift in its corporate structure. This listing highlighted ICON's evolution toward a full-service (CRO) model, encompassing end-to-end services from trial design and patient recruitment to and regulatory submissions, which became a of its international strategy during the late .

Business operations

Core services and offerings

ICON plc operates as a leading (CRO), delivering a comprehensive suite of outsourced services to support across the pharmaceutical, , and industries. Its core offerings encompass full-service management, which includes , site selection, patient recruitment, monitoring, and for trials spanning Phases I through IV, as well as post-approval studies. ICON also provides integrated laboratory services, featuring bioanalytical testing, central laboratory analysis for safety and efficacy endpoints, and specialty assays for pharmacokinetics, immunogenicity, and biomarkers, ensuring harmonized data from a global network. Through its Specialty Laboratories, Advanced Diagnostics Division, and global central laboratories, ICON offers customised assay development for clinical trials, particularly in oncology, utilizing advanced technologies such as next-generation sequencing (NGS), droplet digital PCR (ddPCR), quantitative PCR (qPCR), and reverse transcription quantitative PCR (RT-qPCR). These services include custom biomarker assay development for soluble, cellular, tissue, and molecular biomarkers, along with expertise in assay validation, bridging, and regulatory support, including FDA Premarket Approval (PMA) and Investigational Device Exemption (IDE) submissions. The laboratory capabilities extend to therapeutic areas such as cell and gene therapies and infectious diseases. Additionally, medical imaging services support trial endpoints through advanced modalities like MRI, CT, and PET scans, with expertise in therapeutic areas such as . In regulatory consulting, ICON assists clients with compliance strategies, submission dossiers, and interactions with health authorities to accelerate approvals. The company further specializes in (RWE) generation and patient-centered outcomes research, leveraging observational studies, registries, and patient-reported outcomes to inform post-market surveillance, , and value demonstration. Through its integrated laboratory capabilities, ICON supports precision medicine in , including companion diagnostics and biomarker-driven trials for targeted therapies in solid and hematological tumors. These services emphasize patient-centric approaches, such as decentralized trial elements and engagement platforms to enhance recruitment and retention. ICON has evolved its portfolio toward healthcare intelligence, incorporating advanced data analytics, AI-driven insights, and commercialization support to optimize clinical development and . This includes statistical programming, modeling, and consulting to bridge clinical evidence with payer requirements and launch strategies. A key differentiator is ICON's end-to-end solutions, enabling seamless integration from early-phase exploratory studies to long-term post-market commitments, which reduces timelines and risks for clients. This global scale facilitates efficient service delivery across diverse therapeutic areas, including rare diseases and immuno-oncology.

Global presence and infrastructure

ICON plc maintains a robust global footprint, employing approximately 39,800 professionals across 95 locations in 55 countries as of September 30, 2025. This extensive network enables the company to support clinical trials and healthcare initiatives worldwide, with a headquarters in , , serving as the central hub for strategic oversight and operations. Major operational centers are concentrated in key regions, including the , , and the . In the , ICON operates significant facilities such as its central in , facilitating North American trial logistics and data management. European activities are anchored in Ireland and extend across the continent for and patient recruitment, while the Asia-Pacific region features a presence in 13 countries, including dedicated labs in and to address diverse therapeutic needs and accelerate regional . The company's infrastructure includes a network of fully accredited central laboratories in Dublin, Ireland; Farmingdale, New York; Singapore; Beijing, China; and The Netherlands, equipped with state-of-the-art instrumentation for harmonized testing in , , and other assays to ensure consistent global data quality. Complementing this are advanced services that leverage cutting-edge technology and biomarkers for trial endpoints, integrated across locations to support imaging analysis from diverse geographies. Digital platforms, such as the ICON Digital Platform and FIRECREST solutions, further enhance global trial efficiency by enabling patient-centric mobile apps, remote site management, and real-time data curation for seamless international collaboration. Post-COVID adaptations have solidified ICON's capabilities in decentralized trials and remote monitoring, with increased integration of virtual check-ins, in-home visits, and agile data analytics to mitigate site visit disruptions while maintaining trial integrity. This shift, accelerated by pandemic-related site closures, now supports hybrid models that reduce patient burden and enable real-time across global studies.

Acquisitions and growth strategy

Major pre-2020 acquisitions

ICON's acquisition strategy in the early 2000s focused on building foundational capabilities in regulatory consulting, laboratory services, and provision. In 2000, the company acquired YRCR Ltd., a UK-based regulatory consultancy, which strengthened its expertise in for pharmaceutical and biotech clients. That same year, ICON acquired a Central in New York (UCT Inc.), enhancing its central laboratory operations for sample analysis. Additionally, the acquisition of Pacific Research Associates bolstered bioanalytical consulting services, particularly in statistics and for . By 2002, ICON expanded its clinical research footprint with the acquisition of BPA (Barton Polanski & Associates), a New York-based provider specializing in execution. In 2003, the company acquired Medeval Group Ltd., a UK-based Phase I clinical pharmacology facility, which added early-phase trial capabilities. Also in 2003, Globomax LLC, a consulting firm focused on support, was integrated to improve strategic consulting in regulatory and clinical planning. The 2004 acquisition of Beacon Bioscience Inc. marked ICON's entry into services, providing specialized support for imaging in clinical trials. In 2006, Ovation Research Group was acquired, enhancing outcomes research and expertise for late-stage studies. The following year, 2007, saw the purchase of DOCS International, a European staffing group, which expanded ICON's functional service provision in staffing across Europe. In 2008, ICON acquired Healthcare Discoveries, a US Phase I provider, further solidifying early-phase clinical capabilities. That year also included the acquisition of Prevalere Life Sciences, a US bioanalytical lab, which advanced laboratory testing for and . By 2009, Veeda Laboratories, a biomarker lab, was added to support analysis in . The 2010 acquisition of Timaq Inc. complemented existing imaging services by adding advanced European-based imaging support for and other trials. In 2011, Outcomes, an outcomes consultancy, was acquired to deepen and patient-reported outcomes capabilities. Also in 2011, Firecrest Clinical, a technology provider for site performance and study management, improved ICON's tools for investigator site optimization. ICON's 2012 acquisitions included PriceSpective, a global value strategy consultancy, which enhanced market access and pricing strategies for drug launches. BeijingWits Medical Consulting Ltd., a Chinese CRO, expanded operations in Asia, particularly for clinical trial management in emerging markets. In 2013, ClinForce and Assent, US-based staffing and functional service providers, were acquired to scale resourcing solutions. Akos Limited, an EU pharmacovigilance provider, added drug safety monitoring expertise. The 2014 acquisition of Solutions positioned ICON as a leader in adaptive trial design and execution, particularly for complex and studies. In 2015, MediMedia Pharma Solutions brought scientific communications capabilities to support commercialization efforts. PMG Research Inc., a network of sites, enhanced site engagement and patient recruitment. In 2016, Management Inc. extended ICON's reach into government-sponsored research, focusing on vaccines and infectious diseases. The 2017 acquisition of MAPI Group significantly bolstered late-phase services, including patient-centered outcomes research. Finally, in 2019, Clinical Research was acquired to advance at-home patient and site support services. MediNova Research, a European and African site network, expanded site infrastructure in EMEA. , a molecular diagnostics lab, enhanced oncology-focused precision medicine testing. These pre-2020 deals collectively built ICON's integrated platform across regulatory, , , and late-phase domains.

Key 2020s acquisitions and integrations

In 2020, ICON PLC acquired MedPass International, a leading European (CRO) specializing in , reimbursement, and clinical trials. This acquisition enhanced ICON's capabilities in the and diagnostics sector by integrating MedPass's expertise in navigating complex European regulatory landscapes and supporting strategies for innovative devices. The most transformative deal of the decade came in 2021 when ICON acquired for approximately $12 billion in a cash-and-stock transaction, completed in July of that year. This merger combined two major CROs, creating a global powerhouse with over 38,000 employees across 47 countries and solidifying ICON's position as a top-tier provider of services. The integration of PRA's data analytics, technology platforms, and therapeutic expertise enabled ICON to accelerate through advanced healthcare intelligence, decentralized trial solutions, and broader access to diverse patient populations. Building on this foundation, ICON pursued targeted expansions in 2024 to bolster digital innovation and regional presence. In February 2024, the company acquired Clinical Research Management, Inc. (ClinicalRM), a provider of full-service and functional research solutions to U.S. government agencies, specializing in infectious diseases, vaccine development, and bio-threat response. This acquisition extended ICON's presence in the government-sponsored research market and enhanced its capabilities in vaccines and infectious diseases. In January, the company acquired HumanFirst, a cloud-based technology platform specializing in digital health measures for clinical trials, for $13.3 million. This integration enhanced ICON's patient engagement technologies by incorporating HumanFirst's library of over 3,000 validated digital endpoints and tools, enabling more precise, patient-centered outcome assessments in precision medicine studies. Later that year, in August, ICON acquired KCR, a mid-sized Poland-based CRO with around 900 employees, focusing on full-service and functional service provision (FSP) in clinical trials. The addition of KCR expanded ICON's European footprint, particularly in Central and Eastern Europe, while integrating its biotech-focused services to support flexible outsourcing models for emerging therapies. These 2020s acquisitions reflect ICON's strategic rationale of market consolidation, , and precision medicine advancement. By merging scale with innovative tools, ICON has positioned itself to address evolving demands in , such as hybrid trials and data-driven insights, while expanding therapeutic and geographic reach without overlapping prior incremental growth.

Leadership and governance

Executive leadership

As of November 2025, ICON plc is led by Barry Balfe, who was appointed to the role on October 1, 2025, succeeding Dr. Steve Cutler, who served as CEO from 2017 to 2025. Balfe, a long-tenured executive with over 20 years at , previously held the position of since January 2025 and before that served as President of ICON Pharma Solutions, where he drove growth in pharmaceutical development services. His background in operational leadership and deep industry knowledge in clinical research organizations (CROs) emphasize efficient trial delivery and client partnerships, aligning with ICON's focus on accelerating . The is Nigel Clerkin, who joined in October 2024 after a career spanning financial leadership in the pharmaceutical and healthcare sectors. Clerkin began his professional journey at and later held senior finance roles at Elan Corporation and as at Let'sGetChecked, bringing expertise in financial strategy for biotech and diagnostics firms that supports 's global scaling in CRO services. He holds a and Master of Accounting from and is a qualified . Dr. Ute Berger serves as and President of ICON Development Solutions, overseeing medical strategy and early-phase development critical to ICON's CRO pipeline. Board-certified in , , and medical , Berger earned her from the University of Heidelberg and previously led roles at before joining ICON, where she advances integrated solutions in and digital trial innovations. For operations, Rose Kidd is President of Delivery, managing site services and execution across ICON's network. With over 30 years at since joining in 1994 as a , Kidd progressed through to senior roles, emphasizing and data-driven delivery in global clinical trials. Under Balfe's , the executive team prioritizes in decentralized trials and AI-enhanced processes to improve CRO productivity and client ROI, as evidenced by ICON's recognition for phase 1 performance in 2025.

Board structure and CEO transitions

ICON plc's board of directors consists of nine members as of late 2025, with seven comprising the majority to ensure objective oversight. The board includes a chairman (Ciaran Murray, independent), the (Barry Balfe, non-independent), a lead ( Murphy), and six non-executive directors, four of whom are independent. Key committees include the , chaired by an and comprising three independent members ( Murphy, Eugene McCague, and Julie O’Neill), responsible for financial reporting and internal controls; the Compensation and Organisation Committee, also with three independent members ( Murphy, Julie O’Neill, and Linda Grais), focused on executive remuneration and talent strategy; and the Nominating, & Committee, consisting of three independent members (Eugene McCague, Linda Grais, and Anne Whitaker), overseeing board composition, succession, and ESG integration. All standing committees are fully independent, aligning with best practices for accountability in a global organization. Several board members bring extensive expertise in pharmaceuticals and healthcare. Dr. John Climax, a co-founder of , has over 30 years in clinical research, holding a PhD in and serving as an independent . Ms. Julie O’Neill, an , spent more than 30 years in pharmaceutical operations, including as vice president at and , with a BSc in . Dr. Linda Grais, another , is a physician with leadership experience in biotech, having served as CEO of Ocera Therapeutics and holding MD and JD degrees. Ms. Anne Whitaker, independent, has three decades in life sciences, including as CEO of several biotech firms, backed by a BSc in chemistry. These backgrounds enhance the board's strategic guidance on clinical trials and drug development. Significant CEO transitions have shaped ICON's leadership. Dr. Steve Cutler served as CEO from March 2017 to October 2025, having previously been chief operating officer since 2014; during his tenure, he led the transformative $12 billion acquisition of PRA Health Sciences in 2021, which expanded ICON's capabilities and positioned it as a global leader in clinical research. Barry Balfe succeeded Cutler as CEO effective October 1, 2025, after joining the board in September 2025; Balfe, with over 20 years at ICON including as chief operating officer and president of ICON Pharma Solutions, holds degrees in chemistry and expertise in pharmacoepidemiology. Cutler transitioned to a non-executive director role post-CEO. As an Irish-incorporated company listed on , ICON adheres to Irish standards under the Companies Act 2014 and complies with 's listing rules for foreign private issuers, including requirements for independent board majorities and committee structures, while benefiting from exemptions on certain U.S. proxy rules. The board maintains formal governance guidelines emphasizing ethical conduct, , and , with regular evaluations to ensure alignment with both jurisdictions.

Financial performance

Historical financial overview

ICON plc was founded in 1990 in , , as a small organization with five employees, initially generating modest revenues through contract research services for pharmaceutical companies. The company's early financial trajectory reflected steady , supported by targeted expansions in the 1990s. Its on in May 1998, priced at $4.50 per share, provided essential capital for scaling operations, marking a pivotal influence on subsequent financial development by enabling acquisitions and geographic diversification without detailing specific costs. Through the 2000s and 2010s, ICON experienced consistent revenue expansion, driven by increasing demand for outsourced clinical trial services, culminating in annual revenue of $2.797 billion by 2020, alongside GAAP net income of $332.3 million, total assets of $3.436 billion, and approximately 16,000 employees. The 2021 acquisition of PRA Health Sciences in July significantly accelerated this growth, boosting 2021 revenue to $5.481 billion and net income to $153.2 million, the latter impacted by integration expenses. Revenue continued to rise to $7.741 billion in 2022 and $8.120 billion in 2023, with net income recovering to $505.4 million in 2022 and $612.3 million in 2023. By 2024, revenue reached $8.282 billion, net income climbed to $791.5 million, total assets expanded to $16.878 billion, and the employee base grew to 41,900, underscoring the enduring effects of the 1998 listing and post-2020 expansions on overall financial scale.
YearRevenue ($B)Net Income ($M, GAAP)Total Assets ($B)Employees
20202.797332.33.436~16,000
20215.481153.2Not specifiedNot specified
20227.741505.4Not specified41,100
20238.120612.3Not specifiedNot specified
20248.282791.516.87841,900

Recent results and outlook (2024-2025)

In 2024, ICON plc achieved full-year revenue of $8,282 million, representing a 2.0% increase year-over-year, aligning closely with the company's reaffirmed guidance range of $8,260 million to $8,300 million. Adjusted EBITDA reached $1,735.8 million, while adjusted totaled $1,162.7 million, supporting an adjusted (EPS) near the midpoint of the prior guidance of $13.90 to $14.10. Net business wins for the year amounted to $9,974 million, contributing to a closing backlog of $24.7 billion. Entering 2025, reported first-quarter of $2,001.3 million, a 4.3% decline from the prior year, amid cautious biopharma spending. net income was $154.2 million, or $1.90 diluted EPS, with adjusted EPS of $3.19, surpassing analyst expectations despite the dip. Net business wins stood at $2,022 million, yielding a book-to-bill of 1.01, and the backlog remained stable at $24.7 billion, up 0.3% from year-end 2024. Second-quarter results showed revenue of $2,017.4 million, a 0.8% sequential increase, driven by improved win rates. net income rose to $183.0 million, or $2.30 diluted EPS, up 30.7% year-over-year, while adjusted EPS of $3.26 exceeded forecasts. Gross business wins grew 10.6% from the prior quarter to $2,966 million, with net wins of $2,057 million and a book-to-bill of 1.02. In the third quarter, revenue advanced 1.3% sequentially to $2,042.8 million, beating estimates by 3.03%. net income fell sharply to $2.4 million, or $0.03 diluted EPS, due to a $165.3 million goodwill impairment charge; however, adjusted net income was $258.8 million, delivering adjusted EPS of $3.31, a 1.5% rise from the second quarter and above consensus. Year-to-date reached $687.2 million, bolstering liquidity with total 2025 share repurchases at $750 million. Looking ahead, updated its full-year 2025 guidance in the third quarter to of $8,050 million to $8,100 million, reflecting a modest 0.3% growth at the midpoint over 2024 and an upward revision of $75 million from prior expectations. Adjusted EPS guidance remains $13.00 to $13.20, emphasizing backlog conversion amid ongoing biotech recovery challenges, with the $24.7 billion backlog signaling sustained future visibility. levels were managed effectively, with net to adjusted EBITDA at approximately 1.5x entering the year.
PeriodRevenue ($M)Adjusted EPS ($)Net Wins ($M)Backlog ($B)Book-to-Bill
FY 20248,282~14.009,97424.7-
Q1 20252,001.33.192,02224.71.01
Q2 20252,017.43.262,057-1.02
Q3 20252,042.83.31---
FY 2025 Guidance8,050–8,10013.00–13.20---

References

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