Voluntary Submission Research Articles

No Soliciting: Strategies for Managing Unsolicited Innovative Ideas

Unsolicited ideas, the non-contractual and voluntary submission of innovation-related information from external sources to the firm, hold the promise of becoming an almost costless and limitless font for firms’ innovative efforts. In contrast, in this paper, we analyze the difficulties associated with unsolicited ideas processes to understand the problems that firms intending to engage in this form of open and distributed innovation are facing. In particular, we look at the costs that arise from the managerial attention unsolicited ideas require, and the legal setting the process is embedded in. We do so using a series of exploratory interviews, an in-depth case study, and a web-based analysis of the current management practices used by the world’s 150 largest firms. Highlighting quality, quantity, and Intellectual Property issues as the key concerns, we uncover that firms use distinct strategies, which we label signaling, structuring, and selecting, to increase the efficiency and efficacy of the unsolicited ideas process. We discuss the implication of our findings for theories of open and distributed innovation and for management practice.NOTE: Please note that the published version has been substantially extended beyond this draft. Please see Alexy, O., Criscuolo, P., & Ammon, S. 2012. Managing unsolicited ideas for R&D. California Management Review, 54(3): 116-139.

Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact

Heterogeneity in the underlying mechanisms of disease processes and inter-patient variability in drug responses are major challenges in drug development. To address these challenges, biomarker strategies based on a range of platforms, such as microarray gene-expression technologies, are increasingly being applied to elucidate these sources of variability and thereby potentially increase drug development success rates. With the aim of enhancing understanding of the regulatory significance of such biomarker data by regulators and sponsors, the US Food and Drug Administration initiated a programme in 2004 to allow sponsors to submit exploratory genomic data voluntarily, without immediate regulatory impact. In this article, a selection of case studies from the first 5 years of this programme - which is now known as the voluntary exploratory data submission programme, and also involves collaboration with the European Medicines Agency - are discussed, and general lessons are highlighted.

Pregnancy After Renal Transplantation—Setting Up a National Registryin in Brazil

Bearing in mind the current advances in transplantation medicine and surgery and the advent of better immunosuppressive therapy resulting in the improvement in graft survival, recipients have a better quality of life and therefore, it is no surprise that there is an increase of pregnancy rates in this group of women. Since the first successful pregnancy in a renal transplant recipient reported by Murray et al. (1), many centers have contributed to a better understanding and the management of this special group of patients. A significant example of such a contribution is the National Transplantation Pregnancy Registry (NTPR) established by Armenti et al. in 1991 at Thomas Jefferson University, Philadelphia, PA. Data from the NTPR have helped to consolidate the reassurances in publications of smaller experiences that successful pregnancies are possible in the transplant population as well as to keep care givers abreast of important issues such as gestational- and organ-specific problems, the role of the new immunosuppressants, and the remote effects of pregnancy on both graft prognosis and offspring. Registration based on voluntary submission of information will always have worries about ascertainment and indeed, NTPR may not capture more than 40% to 50% of all pregnancies in the United States, but this type of well-organized data collection is still worthwhile. Sadly, the U.K. Registry, with an ascertainment of approximately 90%, was discontinued in 2001, as reported in this journal (2). Brazil is one of the most important centers in the field of organ replacement therapy, mainly regarding renal transplantation (3). In 2008, a total of 3809 renal transplantations were performed countrywide, and there are currently 136 active centers for this procedure in Brazil. Women with end-stage renal disease are frequently infertile and because approximately 20% of the transplanted patients in our country are women of child-bearing age, it is possible that every year more than 600 women could have their fertility capacity restored after renal transplantation. In Brazil, we have noticed that the desire to conceive becomes strong among these women and that, as is already known, pregnancy is not safe in these cases. Previous reports have emphasized the high incidence of hypertension, anemia, renal function deterioration, preeclampsia, preterm delivery, preterm rupture of membranes, fetal growth restriction, and stillbirths (4). In addition, there are special concerns about immunosuppressive therapy during pregnancy because all these patients must maintain their medications. In 2001, in Brazil, to determine the characteristics of pregnant women with renal transplant and their follow-up, a multidisciplinary team was established at the Federal University of Sao Paulo (5). After 8 years of experience, we realized the need to share our experiences with other centers in Brazil and that the best way to do this was to set up a National Registry. The idea of having a Registry was always in the back of our minds, but it was the encouragement received from Professor John M. Davison (Newcastle University, United Kingdom), which prompted us to pursue this endeavor, and for this, our partnership with the Brazilian Association of Organ Transplantation was really decisive. So, we hope now that all registered centers in Brazil will be able to access an electronic form to submit data on pregnancy in renal transplant recipients. These data will be analyzed by a multidisciplinary team, and based on the discussions and conclusions, feedback will be given to all centers. Data may also be published in international journals and in regional informative books to further help and guide medical communities and patients. In summary, this is really a pivotal moment for us, and we believe that important data will accrue the analysis of which will improve clinical outcomes for mothers and their babies and achieve overall a better quality of life for our organ transplant recipients. Leandro G. de Oliveira1 Nelson Sass1 Hélio T. Silva, Jr.1 Jose O.M. Pestana1 Antonio F. Moron1 Marilda Mazalli2 Valter D. Garcia3 1Department of Medicine Federal University of Sao Paulo Sao Paulo, Brazil 2Department of Medicine University of Campinas Sao Paulo, Brazil 3Complexo Hospitalar Santa Casa de Porto Alegre Porto Alegre, Brazil

Business Demography in the 21st Century

Murdock and Swanson (2008) observe that applied demography is evolving as the 21st century unfolds and that data bases, substantive issues and methodological approaches seldom considered just a few years ago have become mainstream concerns in the field. Making up applied demography are two subsets: (1) public sector demography; and (2) business demography. Swanson and Pol (2008) argue that although estimation and projection are the heart and soul of both sectors and many methods and materials are common to both, it is useful to distinguish business demography from public sector demography because the unique, profit-oriented and often times proprietary nature of the work justifies separate consideration for business demography. Thus, in this special issue of Population Research and Policy Review, we are pleased to present an overview of the field of business demography at the dawn of the 21st Century. This overview is meant to largely complement examinations that have preceded it in the later part of the 20th century and in the earlier part of this one. Six books and three papers come to mind in this regard. The books include those by Rives and Serow (1984), Murdock and Ellis (1991), Kintner et al. (1994), Pol and Thomas (1997), Siegel (2002), and Murdock and Swanson (2008). The paper by Swanson et al. (1996) provides a useful overview of the development of applied demography and its two subsets, as do the papers by Smith and Morrison (2005) and Swanson and Pol (2008). This attempt to provide a current overview of the increasing breadth and depth of the field of business demography has its roots in an international seminar sponsored by the International Union for the Scientific Study of Population and organized by its Scientific Panel on Business Demography. The Panel consisted of Farhat Yusuf (Chair), Tom Exter, Lu Jiehua, Louis Pol, Filomena Raccioppi, Eduardo Rios-Neto and Bernard Salt. The seminar was held on 9th–10th October 2007 in Sydney (Australia). It was attended by 25 participants from seven countries (Australia, Brazil, Canada, China, India, Indonesia and the United States). It consisted of seven sessions and a summary meeting. Nineteen papers were presented, which covered a range of issues of interest to business demography. At the conclusion of the seminar, participants were surveyed in regard to their interest in assembling the papers together in some form of publication and asked for suggestions on how this might occur. They were found to be in favor of this next step and the majority suggested having a voluntary submission with a formal review process. It was also suggested that the Panel ask the editor of Population Research and Policy Review if his journal would be interested in having a special issue dedicated to this topic. On receiving a positive response from the journal, Farhat Yusuf and David Swanson agreed to co-edit this special issue. It contains a selection of seven papers. They were reviewed by the co-editors and an international team of reviewers. This special issue touches directly or indirectly on some of the major topics of business demography. It includes papers on consumer demographics (Yusuf and Brooks 2010), use of demographics in site selection (Beckett and Morrison 2010; Morrison and Bryan 2010), forecasting of small area populations (Swanson et al. 2010), human resource management (Clark and Ghent 2010), and demographic training of business students (Martins and Brooks 2010; Swanson and Morrison 2010). The Scientific Panel on Business Demography wishes to acknowledge the logistical support provided by the Sydney office of the Australian Bureau of Statistics and Macquarie University, the financial support of the International Union for the Scientific Study of Population which facilitated the attendance of participants from some developing countries and various colleagues who helped in the reviewing process.

PIDANA CAMBUK DALAM PERSPEKTIF KEADILAN HUKUM DAN HAK ASASI MANUSIA DI PROVINSI NANGGROE ACEH DARUSSALAM

This research discusses the phenomena on Islamic Criminal Law enforcement by applying whipping in the perspective of justice and human rights. Analysis is based on empirical research result in Nangroe Aceh Darussalam using socio-legal approach. Research data includes regulation related to Islamic Law enforcement and dynamic thought of the actors involved in the enforcement of Islamic Law. The research result shows that the competency of sharia court is limited to some criminal conduct regulated in qanun. Competency is limited to the Islam citizen. Key words : Syaria’ court, criminal act, voluntary self submission

Voluntary submission of biological specimens from cancer clinical trials: An update of the Eastern Cooperative Oncology Group experience

6597 Background: Recent advances in cancer therapy underscore the need to acquire biological specimens from participants in well-conducted clinical trials. The Eastern Cooperative Oncology Group (ECOG) has previously reported a high rate of assent to the banking of biological specimens from participants in ECOG led trials. Methods: Since November 2000, ECOG trials include the Intergroup Specimen Banking Committee (ISBC) consent form governing biological specimen use. Data collected at patient registration regarding assent to specimen submission for correlative projects and/or banking are maintained in a data-base at the ECOG Coordinating Center. These data include participant responses to all questions contained in the consent from, and can be associated with study specific information and demographic data. Results: From November 2000 to August 2008, 30,695 participants were accrued from both academic centers and community based practices to ECOG led trials that included a voluntary request for biological specimens for correlative research, banking, or both. Overall, of the 30,496 participants presented with a request for specimen banking, 88.0% agreed to do so. Variance in assent rates for banking was noted by disease type. Permission to bank specimens was provided by 93.8% of leukemia patients (pts), 93.5% of breast cancer pts, and 91% of gastrointestinal cancer pts, whereas 75.7% of thoracic cancer pts, 75.0% multiple myeloma pts, and 63% of pts on prevention trials agreed. Data from 12,605 participants presented with a protocol-specified correlative project consent form are currently being analyzed. Interactions based on disease type, age, gender, type of institution and phase of study will be evaluated for biological specimen acquisition for banking and correlative use. Conclusions: Overall, a high rate of assent is demonstrated for biological specimen acquisition for banking purposes from participants in ECOG led clinical trials. Differences in assent rates for banking are suggested based on disease types. Further study to better define associations for suboptimal participation and reasons for refusal are planned. No significant financial relationships to disclose.

S06: US FDA and US EPA voluntary submission of genomic data guidance: Current and future use of genomics in decision making

Appropriate utilization of data from toxicogenomic studies is an ongoing concern of the regulated industries and the agencies charged with assessing safety or risk. An area of current interest is the possibility of toxicogenomics to enhance our ability to develop higher or high-throughput models for predicting potential safety concerns or for rapidly identifying biomarkers of exposure or effect. These models could be developed to predict potential health concerns, prioritize testing strategies, or establish prognostic markers by helping to identify exposure to effect linkages. The US Food and Drug Administration has developed a guidance for voluntary submission of genomic data in support of investigative new drug or new drug or biomarker applications. US FDA considers this approach to be a way to share information, realizing that most genomic data are currently used for exploration or research. The value to submission is to provide an opportunity for regulatory scientists to become familiar these data and to develop approaches for proper interpretation. The US Environmental Protection Agency has developed a draft guidance for submission of genomic data. Like the US FDA, these data are not required, but the opportunity to submit these data in an organized way allows both the regulated community and the agency to develop useful procedures for interpreting this new science. Currently, the value of this information has been in confirming biological or toxicity pathways and developing predictive models for prioritizing further testing. Establishing methods for application in safety and risk assessment are in the early stages of development. [This abstract of a proposed presentation does not reflect the policy or opinion of the US EPA]

Separation of powers: new perspectives and empirical findings—introduction

The doctrine of separation of powers is an important pillar of modern liberal democratic theories of the state. While we find discussion of the separation of powers as a crucial factor in the organization of government in Plato’s writings, the modern doctrine of separation of powers originates from the writings of John Locke, who advocated the separation between the legislature and the executive; Montesquieu, who introduced the judiciary as the third branch of government; and the American founding fathers, particularly Madison and Hamilton, who contributed to the desirable mode of relations between the powers—checks and balances, and introduced the horizontal separation of powers between central and local governments. Over the last decades, the structure of governance and the factually implemented separation of powers have experienced far-reaching changes. In some areas of the world, entirely new levels of governance have emerged (such as the supra-national level of the European Union). In addition, voluntary submission to internationally agreed institutions and ‘rules of the game’ (e.g., the WTO) plays an increasingly important role in all parts of the world. Domestically, the trend towards transparency and accountability has led to the creation of a number of new actors such as central banks, independent competition agencies, election commissions, anti-corruption commissions and alike. In many states, the possibility for direct participation in political decision-making by citizens, which bear on the original rationales of the doctrine of separation of powers, has markedly increased over recent years.

Negotiated Case-ending Settlements: Ways of Speeding up the (Court) Process

The subject of this article is a special type of fast-tracked case-ending decisions called “negotiated case-ending settlements”. Those proceedings are based on a kind of agreement between the parties, end with a real conviction of the offender and their legal consequence is a true but mitigated punishment. They can be found in six of 11 countries studied, namely, in England & Wales, Croatia, France, Hungary, Poland and Spain. The English guilty plea procedures, the French appearance before a court after prior admission of guilt and the Polish prosecutor’s application for a conviction to be rendered without a trial as well as the voluntary submission to penalty are examined more closely here. The comparative study focuses on the stage, where the negotiation is made, the conditions for the use of these settlements and the PPS’s role therein.

Integration and Use of Biomarkers in Drug Development, Regulation and Clinical Practice: a US Regulatory Perspective

The US FDA encourages the integration of biomarkers in drug development and their appropriate use in clinical practice. It is believed that this approach will help alleviate stagnation and foster innovation in the development of new medical products, and, ultimately, lead to more personalized medicine. To facilitate the use of biomarkers in drug development and clinical practice, the FDA organized workshops, issued guidances, established a voluntary submission process, developed online educational tools and, most importantly, strives to ensure the integration of this information into drug labels, for example, via the update of existing labels, or the inclusion of appropriate language in new drug labels. A pilot process has been set up to qualify novel biomarkers that are not associated with specific drug products, but are of more common use (e.g., biomarkers for drug safety). In addition, the FDA has initiated the creation of various consortia that are working towards the identification and characterization of exploratory biomarkers in order to qualify them for a specific use.

POLICY CHANGES IN BUDGET BILL

WHEN PRESIDENT George W. Bush signed the huge 2008 omnibus federal spending bill late last month, it included several non-budget-related provisions that will impact the chemical enterprise. The last-minute appropriations measure gave members of Congress the opportunity to insert many unrelated measures into the law, including chemical plant security rules, restrictions on chemical fertilizers, and mandatory access to NIH research results. The open-access provision orders NIH to provide the public with online access to published research that was supported by NIH. This means that all NIH-funded investigators will be required to deposit electronic copies of resulting peer-reviewed manuscripts to PubMed Central—NIH’s online, publicly accessible journal archive—for posting no later than 12 months after publication. NIH’s current policy calls for voluntary submission of manuscripts. Journal publishers, including the American Chemical Society (which publishes C&EN), have expressed reservations about the mandato...

Herrschaft und Geschlechterhierarchie. Zur Funktionalisierung der Zenobiagestalt und Anderer Usurpatoren in den Viten der Historia Augusta

The figure of the Palmyrean queen Zenobia plays an important part in three vitae of the Historia Augusta (Gall., trig. tyr., Aurel.). The discrepancy in her representation was attributed to different sources or different authors. Since the representation of Zenobia even changes within one vita, there is no need to assume different authors. Being a counterpart to Gallienus, Odaenathus and Aurelianus, the figure of Zenobia changes correspondingly to these male figures. Her voluntary submission to the real – male – emperor finds an equivalent in the nation's voluntary submission to the real – male – ruler. The category of gender proves valuable in the analysis of characterisation and text intention. The vita Aureliani is interpreted as deconstructing the panegyric tones of the vitae Gallieni and triginta tyrannorum.

Morbidity and mortality of pneumococcal meningitis and serotypes of causative strains prior to introduction of the 7-valent conjugant pneumococcal vaccine in England

To assess the incidence of pneumococcal meningitis, associated deaths and serotypes of causative pneumococci in England prior to the inclusion of the 7-valent conjugated pneumococcal vaccine in the routine childhood immunisation programme in 2006. Cases were identified using hospital episode statistics (HES) and voluntary reports or submission of isolates to the Health Protection Agency. Mortality data and population estimates were from the Office for National Statistics. Based on HES, the annual incidence of pneumococcal meningitis was about 1 case per 100,000 population between 1998 and 2005 (an average of approximately 480 cases per year) with case fatality rates increasing from 5% in <15 year olds to 30% in >64 year olds. Enhanced surveillance comprising a combination of voluntary reporting of cases and referral of isolates gave case ascertainment rates of 50-70% compared to those derived from HES, and similar case fatality rates. The age distribution of pneumococcal meningitis was similar with both datasets, infection being reported mostly commonly in children aged less than 5 years, with the highest incidence in children aged 2-11 months. Based on the serotype distribution of isolates obtained in 2005, the serotype coverage afforded by the 7-valent conjugate vaccine is 72% for patients aged less than 2 years. These data provide baseline information on the incidence of pneumococcal meningitis and associated mortality, together with the serotypes of infecting strains of pneumococci, which will be critical for evaluation of the public health impact of the 7-valent conjugated pneumococcal vaccine in England.

Paving the Critical Path: How can Clinical Pharmacology Help Achieve the Vision?

It has been almost 3 years since the launch of the FDA critical path initiative following the publication of the paper "Innovation or Stagnation: Challenges and Opportunities on the Critical Path of New Medical Product Development." The initiative was intended to create an urgency with the drug development enterprise to address the so-called "productivity problem" in modern drug development. Clinical pharmacologists are strategically aligned with solutions designed to reduce late phase clinical trial failures to show adequate efficacy and/or safety. This article reviews some of the ways that clinical pharmacologists can lead and implement change in the drug development process. It includes a discussion of model-based, semi-mechanistic drug development, drug/disease models that facilitate informed clinical trial designs and optimal dosing, the qualification process and criteria for new biomarkers and surrogate endpoints, approaches to streamlining clinical trials and new types of interaction between industry and FDA such as the end-of-phase 2A and voluntary genomic data submission meetings respectively.

Nanotechnology Nexus—Intersection of Research, Science, Technology, and Regulation

ABSTRACT Not a day passes where nanotechnology does not make headlines in the popular press, scientific journals, as well as in the regulatory arena. Environmental and public health activists are voicing a growing concern and focus on the risks potentially posed by nanotechnology and the ability of the government to regulate these new and exciting technologies. Whereas such concerns state the need for stringent, precautionary, and almost exclusionary approaches to the regulation of nanotechnology, many entities believe that a voluntary approach to these often novel materials and technologies is the appropriate and sensible path. In this editorial, we discuss the importance of nanotechnology, who cares, and the available options for approaching the regulation of this often novel technology. We focus on the U.S. Environmental Protection Agency (USEPA) and its voluntary regulatory data submission program as the preferred alternative.2 2Comments are those of the authors and do not necessarily represent those of their employers.

Family Evaluation of Hospice Care: Results from Voluntary Submission of Data Via Website

The Family Evaluation of Hospice Care (FEHC) survey is a 61-item questionnaire that surveys family members about care provided to the decedent by the hospice. Hospices submit their data to the National Hospice and Palliative Care Organization (NHPCO), where results are tabulated. For the first two quarters of 2004, a total of 29,292 surveys were tabulated. On average, respondents rated their overall satisfaction with care as 47.1 on a 50-point composite scale of five measures of satisfaction. Opportunities for improvement were identified for attending to family needs for support (18.2% of those surveyed reported at least one unmet need), attending to family needs for communication (10–29%), and coordination of care (22.1%). Surrogate reporting of unmet needs for pain, dyspnea, or emotional support ranged from 5.3% to 9.8%. The FEHC is a useful tool for measuring hospice performance and identifies a number of opportunities for improvement.

The role of the Vaccine Adverse Event Reporting system (VAERS) in monitoring vaccine safety.

The role of the health professional in supporting the national passive surveillance system is essential, as the first hint of a potential problem usually originates with the astute clinician who reports a case to the appropriate source. The investigation that resulted in the voluntary withdrawal of rotavirus vaccine was triggered by nine reports to VAERS of intussuception, eight of which had occurred within 1 week of the first dose of this vaccine. Health professionals have access to the most complete information related to adverse events experienced by their patients. Any index of suspicion that a serious event or death may be related to vaccination is reason for the health professional to submit a VAERS report. Determination of whether an event was caused by the vaccine is not a prerequisite for filing a VAERS report. When in doubt, providers should report to VAERS. VAERS solicits reports for all events temporally related to vaccination, some of which may be coincidental and some of which may merely indicate a change in the frequency of expected events. Post-marketing surveillance relies on health professionals to report suspicious events, thus improving the quality of reported data and contributing significantly to safeguarding public health. Recommendations for healthcare professionals to report to VAERS recently have been incorporated into the Standards for Pediatric Immunization Practices, which are endorsed by multiple professional organizations. Despite the limitations of spontaneous reports, VAERS provides vital information of clinical importance. The identification of signals in adverse event surveillance may initiate further investigation of potential problems in vaccine safety or efficacy, and facilitate subsequent dissemination of safety-related information to the scientific community and the public. This process begins with voluntary submission of reports of possible vaccine-associated events to VAERS by the informed and conscientious health professional.

Citoyens à l'ombre d'un mur...

Citizens in the shadow of a wall... There is no “scientific” or “objective” solution to the conflict between the Arab countries and Israel ; no more than such a solution exists for a conflict between two individuals. Inter-individual relations do not fit into the framework of first-order, scientific reality, because it is impossible to scientifically determine their nature. Being completely constructed by their partners, such conflicts escape all forms of objective verification. This explains the failure of the naive belief in human reason, based on scientific knowledge, as well as the failure of the hope created in men who are “good by nature”, that their voluntary, spontaneous and reasonable submission to fundamental values which, when established scientifically, always turn out to be the best, and that, therefore, individual needs and desires will one day coincide perfectly with those of society...

The Economic Consequences of Firms' Voluntary Submission to Greater External Scrutiny

There is a significant positive market reaction to merger announcements by acquiring firms that use lower quality external auditors. One explanation for the positive performance of these firms is that their cost-of-capital is reduced as a result of their voluntary submission to the intense scrutiny inherent in the merger process. For the lower quality audit firms, I find that the cost-of-capital effect dominates the over-valuation signaling effect of a stock-for-stock merger previously documented in the literature. I also find that a cash bid conveys to the market a stronger positive signal for low quality audit clients as opposed to high quality audit clients. Because the choice of a high quality auditor is already associated with favorable private information, clients of high quality audit firms tend to benefit less from the announcement of a cash acquisition. The results are robust to controlling for the usual determinants of acquirers' abnormal returns, both acquirers and targets' sizes, and potential sample selection biases.

Law and Culture in Transition

Japan is experiencing peculiar period of political change that started about ten years ago, coinciding with the beginning of the present era under Emperor Heisei. We are witnessing series of law reforms that may be characterized as epoch-making. They are not being planned according to single, systematic program, but they are nonetheless interrelated and they are animated by the same basic spirit, so that we may call them Reforms. Taken as whole, these reforms purport to bring about fundamental structural changes in Japanese society. Since the great Democratizing Reform after World War II, Japanese society and culture have been changing continuously. Although this societal change may be underlying the present reforms, it does not appear to be directly causing them. The present wave of reform cannot be seen simply as the natural outgrowth of previous changes. Many of the present reforms strike us as astonishingly bold in content and rapid in tempo; they would have been unthinkable just few years before. The themes of the Heisei Reform that are repeatedly stressed are deregulation, autonomy, competition, self-responsibility, and a rule-based social order. These phrases squarely clash with the familiar keywords attached to the Japanese ways of social ordering: protective collectivism, harmony, trust in authorities, consensus, voluntary submission to obligations, etc.l Their impetus has clearly come from the precipitous changes both internal and external to Japanese society, and perhaps they represent desperate reaction of system facing the possibility of its ultimate decline. In my view, we are going through major turning point in our history. The Heisei reform wave is epoch-making because it grapples with none other than the fundamental structure of the legal order itself. It stresses the need for change in the nature of our social order and attempts to reform our legal system as whole. In addition