citi The sponsor must submit an IND Safety Report to the FDA if an adverse event is (1) serious; (2) unexpected; and:

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Answer 1

The sponsor must submit an IND Safety Report to the FDA if an adverse event is

seriousunexpectedthere is a reasonable possibility that the drug caused the event.What is Food and Drug Administration (FDA) ?Located under the Department of Health and Human Services, the Food and Drug Administration (FDA or USFDA) is a federal organization.The FDA is in charge of ensuring the safety of food, tobacco products, dietary supplements, prescription and over-the-counter medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed, and veterinary products in order to protect and advance public health.The Federal Food, Drug, and Cosmetic Act (FD&C) is the FDA's major area of enforcement, although the organization also upholds related regulations and other laws, most notably Section 361 of the Public Health Service Act. A large portion of this regulatory-enforcement job concerns the regulation of condoms, lasers, cell phones, and other items, as well as the prevention and control of disease in settings ranging from domestic pets to donated human sperm for assisted reproduction.

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Related Questions

The channels through which advertising is carried to prospective customers are advertising: Group of answer choices conduits media routes segments waves

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The channels through which advertising is carried to prospective customers are advertising is: advertising media.

What is advertising?

Advertising can be defined as the way of creating product awareness so as to generate sales.

Hence, Advertising media tend to play an important function when it comes to creating product or brand awareness based on the fact advertising media is a channels through which advertising is carried to prospective customers.

The complete question is:

The channels through which advertising is carried to prospective customers; includes newspapers, magazines, radio, television, outdoor advertising, direct mail, social media, and the internet.

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You have been asked by the CEO of Mountaineer Company to assist in analyzing product costs. This analysis is used in internal decision making and in reporting to investors. The following Tableau Dashboard provides data needed for the analysis. 1. (a) Do the accounts shown in the Tableau Dashboard suggest Mountaineer Company is a manufacturer or a merchandiser

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The accounts are shown below for Mountaineer Company                                        

                                           Mountaineer Company

                                             Income statement

                                     For the ended December 31  

Sales revenue                                                              $1,000,000Cost of goods sold     Finished goods inventory beginning    $50,000  Add cost of goods manufactured         $444,000   Cost of goods available for sale                                 $494,000Less finished goods inventory, ending                     ($54,000) Cost of goods sold                                                     ($440,000) Gross profit                                                                   $560,000Operating expenses    General and administrative expenses   $75,000  Selling expenses                                     $103,500  Less Total operating expenses                                  ($178,500) Net income                                                                  $381,500

                                    Cost of goods manufactured

Direct materials    Beginning raw materials inventory       $60,000  Add purchase                                         $140,000  Total raw materials available                 $200,000   Less ending raw materials inventory ($64,000)   Raw materials used                                                        $136,000Direct labor                                                                     $180,000Manufacturing overhead     Factory rent                                            $45,000   Repair expenses                                    $11,500  Factory utilities                                        $9,500  Factory supplies                                      $14,000  Indirect labor                                           $38,000  Total manufacturing cost                                             $118,000Add beginning work in process inventory                   $43,000Less ending work in process inventory                       ($33,000) Cost of goods manufactured                                      $444,000

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How are enterprise state roaming (esr) profiles different from other traditional user profiles?

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Answer:

ESR keeps corporate and personal data separate

Explanation:

ESR lets users securely synchronize user and application settings data to the cloud

enterprise usually means business

so a person can upload their work to their server but that doesn't mean they get to see anyone else's work...like corporate secrets, salaries, etc

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Investments in debt securities acquired principally for the purpose of selling them in the near term are classified as ________ securities.

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Investments in debt securities acquired principally for the purpose of selling them in the near term are classified as trading securities.

The definition of investment is an asset that is purchased or invested to build wealth and save money from hard-earned income or capital appreciation. The importance of investment is primarily to gain an additional source of income or to make a profit from the investment over a period of time.

Form of investment shares. Knead. Mutual funds and ETFs. bank product. option. Savings for pension, retirement, and education. Your investment allows you to be independent and not depend on other people's money when you need it financially. You can pay enough for your needs and desires in life.

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Is zero economic profit inevitable in the long run for a monopolistically competitive firm?

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The firm will not continue to earn profit because the cost of production will rise as new firms enter the market. The supply curve shifts to the right as new firms enter, prices fall, and profits fall. Firms will keep entering the industry until economic profits reach zero .Some businesses will leave a sector if it experiences financial losses. will leave.

As the supply curve shifts to the left, price rise and losses fall. The entry of a large number of new firms causes the market supply curve to shift to the right. As the supply curve shifts to the right, market prices begin to fall, and economic profits for both new and existing firms fall.

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Associations detected between measures of neighborhood environmental conditions and human microbiome diversity.

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Association detected between measures of neighborhood environmental conditions and human microbiome diversity are as follows

Michigan state university , Department of geography , Environment  and Spatial Science , East Lansing USAUniversity of Otago , Department of Public Health , Wellington , New Zealand Michigan State University Department of Entomology, East Lansing USAUniversity of Melbourne , Melbourne School of Population and Global Health Melbourne Australia

While emerging research suggest urban green space revegetation increases soil microbiota diversity and native plant species affect skin microbiome diversity, there is still a relationship between neighborhood environment condition and human microbiome.

The environment condition of neighborhood may influence our microbiome through several pathways .

This study provide data on human microbiome samples . They evaluated relationship betweens microbiome and measures of environmental conditions near the home of 126 decendents . There were no potential indicator taxon among NDVI quartiles.

Some highlights of study between measures of neighborhood environmental conditions and human microbiome diversity

This study test how neighborhood environment may effect the human microbiome .For the rectum microbiome NDVI sd mouth and nose shows negative associations with diversity .For the mouth microbiome , they found and effect of percent trees on diversity.

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Consider a good to which a per unit tax applies. the size of the deadweight that results from the tax is smaller if:________

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Consider a good to which a per unit tax applies. The size of the deadweight that results from the tax is smaller, the smaller is the price elasticity of supply.

A deadweight loss is the loss in social surplus which occurs when the economy produces at an inefficient quantity. So, a per unit tax results in a loss in social surplus.

The amount of the deadweight loss varies with both demand elasticity and elasticity of supply. When either demand or supply is inelastic, then the deadweight loss of taxation is smaller, because the quantity bought or sold varies less with price.

Hence, the answer is given and explained above.

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The Jackson Company incorrectly omitted $100,000 of merchandise from its 20X1 ending inventory. In addition, a merchandise purchase of $40,000 was incorrectly recorded as a $4,000 debit to the purchases account. As a result of these errors, 20X1 before-tax income is:

Answers

$64,000
In error, $100,000 worth of goods were left out of The Jackson Company's 20X1 closing inventory. A $40,000 purchase of goods was also mistakenly recorded as a $4,000 debit to the purchasing account. These mistakes result in a $64,000 before-tax income for 20X1.

Due to the company leaving $100,000 out of the stock account, the cost of products sold will increase by $100,000 as well as Earn $100,000. A $4000 negative to the purchase account would result in a $36,000 profit reduction and a $4,000 drop in the cost of goods sold.

Total understate Tax income = $100,000 - $36,000
                                         = $64,000
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If the price level increases in the economy, Group of answer choices The aggregate demand will fall and shift to the left. The total spending in the economy will fall. The aggregate supply will fall and shift to the left. The total spending in the economy will rise.

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The answer is total spending in the economy will rise.

In the broadest sense (and assuming constants), a rise in aggregate demand corresponds to an increase in the price level; conversely, a drop in aggregate demand corresponds to a fall in the price level.

When the price level in an economy grows, so does the average price of all products and services sold. Inflation is measured as the percentage rise in a country's price level over a given time period, which is generally a year. This signifies that inflation is occurring throughout the period in which the price level rises.

Therefore, the answer is total spending in the economy will rise.

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If a call option has a $10 strike price, and the underlying stock is trading at $11, then the option is considered: a. in the money. b. at the money. c. out of the money. d. worthless.

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In the money

Put option holders have the choice, but not the duty, to sell shares of the underlying security by a specific date and at a certain price.

When the strike price of a put option is more than the market value of the underlying securities, the option is said to be in the money.
Put options are frequently used by investors as downside protection to limit or stop a value decline.
If the price of the underlying asset increases, puts can offer investors limited risk exposure to the short market.
The time value of a put option, which is the additional premium an investor will pay above the option's intrinsic value, can also have an impact on the option's value.
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Output per hour of work is the definition of:_______
a. the marginal product of labor
b. increasing returns to labor
c. labor productivity
d. diminishing returns to labor

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When someone refers to the output per hour of work that is done, this is another way of talking about c. labor productivity.

What is labor productivity?

This refers to the amount of work that a worker is able to carry out within a period of time which is usually an hour. It can be calculated by dividing the units produced by the number of hours worked.

This therefore gives the output per hour of work. Labor productivity is best when it is high because it means that a company is producing more goods and services per hour.

The more goods and services produced, the more a company stand to make revenue when it sells these goods and services.

In conclusion, output per hour of work is called labor productivity.

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If an entrepreneur needs help with valuation, they should ______. turn to online sites like BizBuySell and BizQuest rely on the knowledge provided to them by their bank seek out the advice of trusted friends follow their own instinct

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If an entrepreneur needs help with valuation, they should turn to online sites like BizBuySell and BizQuest.

How can sites like BigBuySell help entrepreneurs?

This type of website aims to help entrepreneurs with new business ideas, management tools, and gather opportunities to buy, sell and promote a business.

To be a successful entrepreneur, it is necessary for the individual to have knowledge of the market and the inherent risks, which can be positive, such as opportunities for business expansion, or negative, such as accumulated debt.

Some characteristics of successful and competitive entrepreneurs in the market are:

PlannersCommunication skillsMarket viewInnovation

Therefore, persistence and planning is essential when starting a new business, generating creative and innovative solutions that meet the wants and needs of potential consumers.

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What is the total amount of property, plant, and equipment assuming the accounts above reflect normal activity?

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The total amount of property, plant, and equipment assuming the accounts above reflect normal activity is: $98,000.

How did we arrive at the above number?

All things equal, PPE or Property Plant and Equipment is simply all the items that fit the above description.

From the accounting information given, these would be:

Land - $90,000

Equipment - $ 8,000

Total  = $98,000

What is normal activity in accounting?

Normal activity is the average production volume over a long period of time, taking into account seasonal variations.

The standard factory overhead rate is computed based on this activity level and then applied to the number of units produced.

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Full Question:

The following financial information is from Cook Company:

Accounts Payable $55,000

Land $90,000

Inventory $10,500

Accounts Receivable $7,500

Equipment $8,000

Deferred Revenue $58,500

Short-term Investments $20,000

Notes Receivable (due in 8 months) $45,500

Interest Payable $2,000

Patents $75,000

What is the total amount of property, plant, and equipment assuming the accounts above reflect normal activity?

The limits of trade are those initial _____________ positions that each nation has at self-sufficiency.

Answers

The limits of trade are those initial cost ratio positions that each nation has at self-sufficiency.

Limit of trade is the maximum price range limit that an security which is traded in the security exchange is allowed to fluctuate in one trading session.

A benefit–cost ratio is an indicator of the benefits as well as the cost which is used in cost–benefit analysis.

It is that ratio which  attempts to summarize the overall value for money of a project or proposal.

Every nation will be considered as self sufficient if the cost ratio is zero and there is a fixed limit of trade.

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A process cost system would be appropriate for a:

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Companies that produce a continuous mass of like units through series of operations or process

What is the average of gross income for domestic movies (in mln)?
i. 180
ii. 181. 03
iii. 48. 355
iv. 36. 55

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The average gross income for domestic movies (in mln) is 180

A film industry-specific term used by box office reporters such as Variety and Box Office Mojo. For movies released in North America, box office revenue is usually divided into domestic, including the United States and Canada, and international, including all other countries.

Today, weekly box office revenues are usually considered Friday-Thursday, reflecting the fact that most movies are officially released on Friday in the United States. Variety was published every Wednesday for many years, so most of the weekly box office revenue they reported in the 1920s-1990s was from Thursday-Wednesday.

Most of the Weekly Loss is weekend cashiers. Historically, this has been reported as box office revenue from Friday to Sunday, and holidays close to weekends. Day numbers from Friday to Sunday are also now used.

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Suppose in 2020, you purchase a house built in 2014. Which of the following would be included in the gross domestic product for 2020

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Suppose in 2020, you purchase a house built in 2014. The value of the services of the real estate agent. the value of the services of the real estate agent would be included in the gross domestic product for 2020 This is further explained below.

What is the gross domestic product?

Generally, Final products and services—i.e., those purchased by consumers—are included in GDP, which estimates the value of goods and services produced in a specific period of time.

In conclusion, Imagine that in the year 2020 you decide to buy a home that was constructed in 2014. The price that should be paid for the real estate agent's services. The total value of the real estate agent's services would be included in the calculation of the gross domestic product for the year 2020.

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As a general rule, an illegal contract is automatically _______, so neither party may enforce it against the other.

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As a general rule, an illegal contract is automatically void, so neither party may enforce it against the other.

What is Illegal contract ?

A contract is illegal if it involves doing something that is a criminal act or a civil wrong, or against the public good.

An Illegal contract or agreement is a contraction in terms when a contract is a legal obligation, illegal contract is viewed as a contradiction in terms.

An Illegal contract is called a contradiction for the following reasons listed below:

When a contract has a term that is obligatory, it is called a legal contract.

According to the rules of terms, when a contract is not done legally, it is considered an illegal contract. On the common law of a contract or agreement, when a court does not apply or impose in any case or otherwise for a contract, it is seen as illegal.

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A local pet groomer is considering expanding his services to include cats and needs to decide whether to invest in the necessary equipment and supplies. What type of decision does this represent for the groomer

Answers

This sounds like multiple choice but my guess would be that he has to decide if he will profit off of it making it a strategic decision

Stag industries, annually rewards the top ten employees in terms of goal achievement with a trip to the caribbean. This action of stag industries is based on _____

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Stag industries, annually rewards the top ten employees in terms of goal achievement with a trip to the Caribbean. This action of stag industries is based on Behavior modification theory.

Stag industries are a real estate investment trust which focuses on the acquisition and operation of industrial properties throughout the United States. Stag has developed an investment strategy that helps investors to find a powerful balance of income plus growth.

Behavior modification theory is an approach that, over time, may replace undesirable actions and behaviors with more desirable ones. Here it can be seen Stag industries desirable action and behavior, as they are annually rewarding the top ten employees in terms of goal achievement with a trip to the Caribbean.

Hence, the action of stag industries rewarding their employees is based on behavior modification theory.

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For a business to grow, prosper, and create economic opportunity, many people have to be willing to invest money in it. An advantage of a corporation is its ability to raise money through the sale of

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Corporates raise money through selling their shares. The correct answer is shares. By selling the shares, the corporates get an opportunity to grow, prosper and create economic opportunity.

Why do Corporates sell shares?

All businesses require capital to function. Selling shares in a sale of ownership can be done for a variety of reasons, including debt consolidation, funding business expansion, or risk diversification. Selling shares in a company might bring in a sizable sum of money that can be put toward debt repayment, investments, or charitable contributions. The money may also be reinvested in the company to finance growth. Similar to how selling a portion of a company can lower risk and help owners diversify their own holdings.

Other factors may also motivate business owners to sell their shares. Selling shares gradually can help you plan for eventual succession and transfer ownership in a way that will cause the eventual new owners to experience the least amount of tax shock possible. Finally, selling shares in a company can be the result of burnout or a refusal to expand the company further.

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A promotional tool in which a company lets consumers have a small sample of a product for no charge is known as?

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Sampling is the promotional tool in which a company lets consumers have a small sample of a product for no charge.

Sampling is a process utilized in statistical evaluation wherein a predetermined wide variety of observations are taken from a bigger populace. The method used to pattern from a bigger populace depends on the form of evaluation being accomplished, but it can encompass easy random sampling or systematic sampling.

The number one intention of sampling is to create a consultant sample, one wherein the smaller institution (sample) appropriately represents the traits of the bigger group (population). If the pattern is properly decided on, the sample can be generalizable to the populace. there are many methods to attain a sample.

There are most important forms of sampling methods – possibility and non-opportunity sampling. Chance sampling, also known as random sampling, is a form of sample selection in which randomization is used rather than planned desire.

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True or false: the residual value of a leased asset always impacts the lessee's accounting.
A. True
B. False

Answers

False, the residual value of a leased asset not always impacts the lessee's accounting.

What is the residual value of the leased assets?

The estimated value of a fixed asset after its useful life or lease term is known as the residual value, sometimes known as salvage value. In lease agreements, one of the lessor's main methodologies for figuring out how much the lessee must pay in periodic lease payments is the residual value.

How does residual value affect a lease?

Your monthly payment is affected by the residual value (a higher residual value means a higher monthly payment, compared to a lower residual value for the same vehicles MSRP). Every month and every year, the residual value is different. All leased cars depreciate over time.

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What is the posting reference that will be found in the cash account?

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In accounting, to “post” a transaction means to record it in the journal and/or the account ledgers. A post reference is a code that can guide anyone looking at a specific account ledger (such as accounts payable or accounts receivable) to the corresponding entry in the journal, or vice versa.

A journal entry is the act of recording any transaction, whether one that is economic or not. An accounting diary that displays the debit and credit balances of a corporation lists transactions. Multiple recordings, each of which is either a debit or a credit, may be included in the journal entry.

In your company's books, a journal entry serves as a record of a business transaction. Every transaction requires at least two journal entries in double-entry bookkeeping. A bookkeeper keeps track of all the changes that a transaction can bring about in a business by recording them in their journal.

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The entry made at the end of the accounting period to record wages incurred but unpaid is:________

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The entry made at the end of the accounting period to record wages incurred but unpaid is Accrued expenses, An expense that is recorded on the books before it has been paid is referred to as an accumulated expense, also known as accrued liabilities.

The accounting period in which the expense is incurred is used to record it. Accrued expenses are listed as current liabilities on a company's balance sheet since they represent a company's obligation to make future cash payments. An estimated expense may not match the supplier's invoice, which will arrive at a later time.

According to the accrual method of accounting, costs are recorded as incurred rather than as paid when they are actually incurred.

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Many of Alibaba's customers provide their business customers with a website to use for easy reordering of frequently used supplies, which represent ________ buying situations.

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Many of Alibaba's customers provide their business customers with a website to use for easy reordering of frequently used supplies, which represent straight rebuying situations.

What is straight rebuy?

This is when a company or an organization buys back a product. A straight rebuy occurs when a corporation reorders the same items from the same source in the same amount.

Here, a company places a second order with a supplier that is identical to the first purchase it made.

Companies often re-orders a product from the same supplier or list of supplier they have at hand without having to change to another supplier.

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In the context of leadership styles, which of the following statements is true about the autocratic style

Answers

In the autocratic style, power is exercised by a dominant and dictatorial individual.

What do you mean by autocratic style?

Autocratic leadership, often known as authoritarian leadership, is characterized by a lack of group engagement and individual control over all decisions. When making choices, autocratic leaders usually rely on their own opinions and assessments rather than consulting with their followers.

What are the characteristics of autocratic leadership style?

minimizes or excludes group members' input.requires that practically all decisions be made by leaders.gives managers the power to impose their work procedures and methods.gives the group the impression that they aren't trusted to handle crucial decisions or jobs.

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ulie works in the production department. Julie's wages are an example of ______ expenses for the production department.Multiple choice question.

Answers

In a case whereby Julie's wages are an example of direct expenses for the production department.

What is a Direct Expense?

Direct expense serves as the  expense which is in the same direction from  changes in the volume of a cost object.

Hence, In a case whereby Julie's wages are an example of direct expenses for the production department.

CHECK THE COMPLETE QUESTION BELOW;

Julie works in the production department. Julie's wages are an example of ______ expenses for the production department.

Multiple choice question.

a. direct expenses

b. Indirect expenses

c.cost expenses

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This graph suggests unemployment in the United States will continue to fall. will continue to rise. will remain the same. will only change a little.

Answers

The Graph suggests unemployment in The United States (b) will continue to rise.

Unemployment tends to occur more frequently among lower income earners in the economy, such as the young and unskilled. These people become relatively work off compared to higher income earners, contributing to poverty and overall inequality in income distribution.

The Following statistics supports why unemployment will continue to rise in  the USIn August 2010, 42.0 percent of unemployed persons had been jobless for 27 weeks or more. Persons who had been unemployed for 27 weeks or more made up 44.9 percent of the unemployed in July and 45.5 percent in June.The number of long-term unemployed (those jobless for 27 weeks and over) declined by 323,000 over the month of August to 6.2 million.

The number of unemployed persons (14.9 million) and the unemployment rate (9.6 percent) were little changed in August. From May through August, the jobless rate remained in the range of 9.5 to 9.7 percent.

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Correct Question - This graph shows the US unemployment rate from August 2010 to November 2011.

This graph suggests unemployment in the United States

a. will continue to fall.

b. will continue to rise.

c. will remain the same.

d. will only change a little.

Using attributes such as slope and distance, GIS can map catchment areas and site territories to understand the energy expenditures for moving across a landscape. This is known as

Answers

Using attributes such as slope and distance, GIS can map catchment areas and site territories to understand the energy expenditures for moving across a landscape. This is known as cost-surface analysis.

What is Geographic Information Systems GIS?

A helpful tool for managing data and doing the scientific studies is geographic information analysis (GIS). It offers a broader perspective for examining topographical features, natural resources, human settlements, and landscapes.

How is GIS used in archaeology?

The critical use of GIS in archaeology is predictive modeling. Archaeologists can precisely estimate the locations of sites with cultural, historical, or agricultural significance by combining historical map data, physical details of an area's landscape, and known knowledge about previous people.

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Determine what type of model best fits the given situation: What is the measure of arc RT It takes 38. 6 kj of energy to vaporize 1. 00 mol of ethanol (mw: 46. 07 g/mol). What will be ssys for the vaporization of 11. 0 g of ethanol at 78. 4 c? 20 x (-5) + 10x (-3) + (-5) (-6)-(3x5) The nurse is reviewing patient teaching with a patient scheduled for a laryngectomy. For which reason will the nurse reinforce careful use of narcotics for postsurgical pain management? Definition about the word revolution During conception there are three stages. What takes place during the second stage which is fertilization?. Use the distributive property to write anaddition sentence equivalent to:8(5+2) _+_+_= 30Use only1,3,5,7,9,11,13,15You can repeat it Which atoms were these molecules made up of and in what relative proportions? which of these atoms plays a central role as the "backbone" to the structure of these atoms? why do you suppose this is? What is it called when one party to a contract transfers the contractual rights and obligations to another but remains liable for the contract terms Please help ASAP! Clear explanations are greatly appreciated! Eating a well-balanced diet, getting regular exercise, not smoking, and avoiding high-risk behaviors are all elements of ________. WILL MAKE BRAINLIEST!! Angles a and b are vertical angles. If m A client who has liver damage is receiving lithium for treatment of bipolar disorder. The nurse understands that which of the following may occur when the client is receiving lithium In contrast to a Level III trauma center, a Level I trauma center must As mean arterial pressure increases, the ________, informing the medulla oblongata that blood pressure has indeed increased. A set of strategies (one for each player) in which each player's strategy is the best option for that player, given the chosen strategy of the player's opponents Write the following sentences in passive form(iii) The Principal gave me the prize(iv) The fish took the baitUnderline the finite verbs in the following sentences(v) He travels on Monday(vi) Tola killed a snakeCorrect the following sentences(vii) I and my brother attend the same school(viii) My senior brother is sleepingUnderline the preposition in the following:(ix) There is much to discover under the sea bed.(x) The accused looked straight into the Judge's eyes The pictures represent three different states of matter.Which order of pictures places molecules with themost amount of motion to the least amount of motion?OX-Y-ZOZ Y-XOY-Z-XOY X-Z