Development of Medicines (Edexcel GCSE Biology)

Exam Questions

3 hours20 questions
1
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1 mark

Patients with scarlet fever can be treated with antibiotics.

New antibiotics need to be tested before they can be used in patients.

Which is the correct sequence for the development of a new medicine?

  A testing in healthy
volunteers
testing using
cultured cells
double blind trials
on patients
  B testing using
cultured cells
double blind trials
on patients
testing in healthy
volunteers
  C testing in healthy
volunteers
double blind trials
on patients
testing using
cultured cells
  D testing using
cultured cells
testing in healthy
volunteers
double blind trials
on patients

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2
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2 marks

Cirrhosis is a disease caused by prolonged alcohol abuse.

(i)

Prolonged alcohol abuse causes cirrhosis of the

(1)

  A brain
  B liver  
  C heart
  D skin

(ii)


Give one reason why cirrhosis is described as a non-communicable disease.

(1)

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35 marks

Body mass index (BMI) is calculated using the equation:

(i)

Person A is 1.8 m tall and has a mass of 64.8 kg.

Calculate the BMI of person A.

(2)

(ii)

Figure 1 shows some information about BMI.

BMI BMI category

less than 18.5

underweight
18.5 to 24.9 healthy weight
25 to 29.9 overweight
more than 29.9 obese

Figure 1

Person B has a BMI of 18.5.

Which category is correct for person B?

(1)

  A underweight
  B healthy weight
  C overweight
  D obese

(iii)

Person C has a BMI of 28.5.

Explain one way person C could change their lifestyle to reach a healthy weight.

(2)

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4a
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2 marks

Separate: Biology Only

Higher Tier Only

Monoclonal antibodies are released from cells called hybridoma cells.

Figure 1 shows the process used to produce these cells.wVVqPsZt_monoclonal-antibodies-graphic

Figure 1

Which two types of cell are cell A and cell B in Figure 1?

4b
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2 marks

Separate: Biology Only

Higher Tier Only

Why is it necessary to produce a hybridoma cell instead of using a white blood cell alone to produce monoclonal antibodies? 

4c
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1 mark

Separate: Biology Only

Higher Tier Only

Describe stage X from Figure 1, which follows antibody production from a hybridoma cell. 

4d
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2 marks

Separate: Biology Only

Higher Tier Only

One of the uses of monoclonal antibodies is in cancer treatment. 

Describe two ways that monoclonal antibodies can be used to treat cancer. 

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5a
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4 marks

Separate: Biology Only

(i)
Define the inhibition zone and state its role.

(2)

(ii)
The diameter of an inhibition zone is 8 mm. 

Calculate the area of the inhibition zone.

(2)

5b
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4 marks

Illustrate the key differences between bacterial cells targeted by antibiotics and viral cells by filling in Table 1 below.

Table 1

Aspect Bacteria Viruses
Type of organism   Non-living particles
Size Larger  
Reproduction   Invading host cells and hijacking their machinery
Target of antibiotics Affects cell wall synthesis  
5c
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1 mark

Which of the following statements accurately describes the primary action of statins in treating Cardiovascular Disease (CVD)?

  A Statins block an enzyme in the liver, increasing the rate of fatty material in the blood
  B Statins inhibit inflammation enzymes, reducing the risk of blood clot formation
  C Statins promote cholesterol synthesis, maintaining blood vessel elasticity
  D Statins prevent the formation of atherosclerosis by targeting arterial plaque directly
5d3 marks

State and explain three lifestyle changes that can reduce the risk of developing Cardiovascular Disease (CVD).

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1a
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5 marks

Microorganisms can be cultured in the laboratory to investigate the effect of antibiotics and disinfectants.

Figure 1 shows the process involved in preparing the culture under aseptic conditions.

mOppPGD2_1

Figure 1
(i)

The petri dish containing agar shown in Stage 1 has been prepared by heating to 160 °C before it can be used in Stage 2.

Explain why this is a necessary step before preparing the required bacterial cultures. 

(2)

(ii)

Identify two other stages in Figure 1 which show aseptic technique and explain how they ensure preparation of an uncontaminated culture.

(2)

(iii)

Explain why the petri dish should not be incubated at a temperature higher than 25 °C in the final stage.

(1)

1b
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1 mark

During the incubation period, bacterial colonies will develop on the agar medium.

State the name of the process by which bacteria reproduce.

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2
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5 marks

Some scientists investigated the effect of two antibiotics (methicillin and penicillin) on the growth of two different bacteria.

They used filter paper discs soaked in antibiotic solution and placed the discs on two agar plates, one had been spread with bacteria A and the other with bacteria B.

The filter paper discs were prepared as follows:

  1. Control

  2. Penicillin

  3. Methicillin

Figure 1 shows the results from the investigation:

uIml3Zz__1
Figure 1
(i)

Suggest what the paper disc might have been soaked in for the control.

(1)

(ii)

Describe and explain the results in Figure 1.

(4)

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3a
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9 marks

Scientists at a drug company are working to develop a new pain relief drug.

Figure 1 shows the procedure that the scientists must work through before the new drug can be accepted and distributed to patients world wide.

q3a_development-of-medicines_eexcel_gcse_biology_sq

Figure 1
(i)

Outline what is involved in the preclinical tests of the drug.

(2)

(ii)

Give the range for the number of volunteers needed to complete all the clinical trials for the new drug.

(1)

(iii)

Describe how the clinical trials should be carried out.

(6)

3b
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3 marks

Figure 2 shows the effect of penicillin on the structure of a bacterium.

hPALPb3q_4

Figure 2

Explain how the mechanism shown in Figure 2 helps to protect an individual from the harmful effects of the pathogen.

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4a
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3 marks

Higher Tier Only

Monoclonal antibodies can be used to determine blood hormone levels.

Pregnancy test strips use monoclonal antibodies.

The hormone HCG is produced in the placenta in pregnant women.

The kidneys excrete HCG.

Figure 1 shows three pregnancy test strips.

q1a_monoclonal-antibodies_infection-and-response_gcse_aqa_biology

Figure 1

(i)

Which test strip would belong to a woman who is not pregnant?

(1)

(ii)

Pregnancy testing uses monoclonal antibodies.

Give two other uses of monoclonal antibodies. 

(2)

4b
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7 marks

Hepatitis B is an infectious viral disease which infects the liver.

A double-blind trial was carried out to assess the effectiveness of using monoclonal antibodies to treat patients with a hepatitis B infection.

During the trial referred, a number of patients were admitted to the hospital because they felt unwell.

Information about these patients is shown in Figure 2.

Treatment

% of patients within each group admitted to hospital with hepatitis B
Group A: Placebo 6.2
Group B: Monoclonal antibody

1.8

Figure 2 

3 000 patients were involved in the trial.

Half the patients (Group A) were given the placebo.

Half the patients (Group B) were given the monoclonal antibody being tested.

(i)

Outline how a double-blind trial would be carried out.

(3)

Higher Tier Only

(ii)

Explain how injecting a patient, suffering from hepatitis B, with a specific monoclonal antibody will help in their treatment.

(2)

(iii)

Using the data in Figure 6, calculate the number of patients admitted to hospital with hepatitis B during the trial. 

(2)

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5a
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2 marks

Obesity increases the risk of a person developing cardiovascular disease.

Losing weight can reduce the risk of this disease occurring.

Explain why exercise can cause weight loss.

5b
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2 marks

Figure 1 shows a gastric band fitted to a stomach.

fig-2-1bio-1h-june18-qp-gcse-bio

Figure 1

Explain how a gastric band helps a person to lose weight.

5c
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5 marks

BMI and waist : hip ratio can be used to find out if a person is obese.

Figure 2 shows some data for two males.

male BMI waist : hip ratio
A 27.3 0.85
B ? 0.81


Figure 2

BMI is calculated using the equation:

               BMI = 

(i)

Male B has a mass of 72 kg and a height of 1.81 m.

Calculate the BMI of male B.

Give the answer to 3 significant figures.

(3)

(ii)

Figure 3 shows the interpretation of BMI values.

BMI range interpretation
below 18.5 underweight
18.5 – 24.9 normal
25.0 – 29.9 overweight
30.0 and above obese

     
     Figure 3

Males with a waist : hip ratio above 0.90 are defined as abdominally obese.

Explain what the BMI and waist : hip ratio for male A shows about his weight distribution.

(2)

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6
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6 marks

Higher Tier Only

A scientist was planning to compare the effectiveness of the antibiotic myxopyronin on two different species of bacteria.

Figure 1 shows the equipment the scientist can use.

fig-18-1bio-1h-june18-qp-gcse-bio

Figure 1

(i)

Describe how the scientist could determine the effectiveness of myxopyronin on the two species of bacteria.

(2)

(ii)

Myxopyronin inhibits bacterial RNA polymerase.

Explain why the antibiotic myxopyronin can be used to treat bacterial infections in humans.

(4)

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7a
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4 marks

LDL cholesterol is a type of cholesterol which increases the risk of heart disease.

Statins are drugs used to reduce LDL cholesterol levels.

Figure 1 shows the cholesterol levels in the blood of a man.

He started taking statins at the beginning of February and stopped taking them four months later.

fig-12-1bio-1h-june19-qp-gcse-bio

Figure 1

(i)

Describe the effect of statins on LDL cholesterol levels in the blood.

Use data from the graph to support your answer.

(2)

(ii)

Use evidence from the graph to explain why statins are usually prescribed as life-long medication.

(2)

7b
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1 mark

Which data can be used to calculate the man’s BMI?

  A waist circumference and height
  B waist circumference and hip circumference
  C mass and height
  D mass and hip circumference

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8a3 marks

Streptococcus mutans is one species of bacteria which causes tooth decay.

A scientist tested the effectiveness of toothpaste at killing this species of bacteria.

The scientist spread the bacteria Streptococcus mutans across an agar jelly plate.

(i)

Which word describes the techniques used to prevent contamination of the agar jelly plate?

(1)

  A clinical
  B diagnostic
  C aseptic
  D

lysogenic

(ii)

Give two precautions needed to prevent contamination of the agar jelly plate.

(2)

8b6 marks

The scientist placed a filter paper disc soaked in toothpaste mixed with saliva (disc A) on one half of the agar jelly plate.

A filter paper disc soaked in only saliva (disc B) was placed on the other half of the agar jelly plate.

The agar jelly plate was kept at 37 °C for 24 hours.

Figure 1 shows the results.

fig-5-1bio-1h-nov2021-qp-gcse-bio

Figure 1

(i)

The diameter of the zone of inhibition around disc A is 9 mm.

Calculate the area of this zone of inhibition using the equation πr2.

Use a value of 3.14 for π.

Give your answer to 1 decimal place.

(3)

(ii)

Give a reason why disc B, soaked in only saliva, was included in this test.

(1)

(iii)

Suggest two reasons why this test does not prove that toothpaste kills all bacteria on teeth.

(2)

8c2 marks

Before a new toothpaste can be sold, the toothpaste has to be tested on cultured human cells.

Cultured human cells were placed into four identical flasks.

Saliva was added to each flask and a different brand of toothpaste was added to each of the three flasks.

The human cells were left for two hours and the percentage of cells that were healthy was recorded.

Figure 2 shows the results.

substance added to the human cells percentage of healthy cells after 2 hours (%)
saliva only 85
toothpaste brand 1 84
toothpaste brand 2 86
toothpaste brand 3 85

Figure 2

Explain the conclusion that can be made from this data.

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94 marks

Figure 1 shows how alcohol consumption increases the risk of developing liver cancer.

Someone who does not drink alcohol has a 1.0 risk of developing liver cancer.

fig-8-1bio-1h-nov2021-qp-gcse-bio

Figure 1

(i)

One unit of alcohol contains 8 grams of alcohol.

Calculate the risk of developing liver cancer for someone who consumes 4 units of alcohol a day.

(2)

(ii)

Describe how cancer develops in the liver.

(2)

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10a
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2 marks
Figure 1 shows the structures in a leaf.

fig-4-1bio-1f-june19-qp-gcse-bio

Figure 1

Explain how to structure Z is involved in defence against pathogens.

10b
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3 marks

Chemicals can be extracted from plants.

Some of these chemicals can kill bacteria.

A scientist spread some bacteria on a nutrient agar plate as shown in Figure 2.

fig-5-1bio-1f-june19-qp-gcse-bio

Figure 2
(i)

What is being shown in Figure 2?

(1)

  A aseptic technique
  B cloning
  C genetic engineering
  D selective breeding 

(ii)

Explain why the scientist worked near to a Bunsen burner.

(2)

10c
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4 marks

A scientist spread bacteria onto the surface of two agar plates.

A filter paper disc was placed in the centre of each plate.

Each filter paper disc had been soaked in a different chemical extracted from plants.

The results are shown in Figure 3.

fig-6-1bio-1f-june19-qp-gcse-bio

Figure 3

(i)

The area of a circle is calculated using πr2

Calculate the area of the zone of inhibition for chemical A.

Use π = 3.14

(2)

(ii)

The scientist concluded that chemical A was more effective than chemical B at killing bacteria.

Give two variables the scientist needed to control to make this conclusion valid.

(2)

10d
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2 marks

Some crop plants have been genetically engineered to produce toxic chemicals in their leaves.

Explain one advantage of producing these genetically modified crop plants.

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1a
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4 marks

Coronary Heart Disease (CHD) is a major cause of death worldwide.

Describe how CHD develops and the main causes.

1b
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1 mark

Coronary Heart Disease (CHD) is classed as a non-communicable disease.

Suggest what is meant by a non-communicable disease.

1c
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4 marks

Two types of cholesterol in the blood can have a profound impact on a patient’s health; LDL and HDL.

  • High levels of LDL are associated with coronary heart disease (CHD).
  • High levels of HDL in the blood can reduce levels of LDL.

There are a number of drugs which can be prescribed to increase an individual’s HDL level to reduce their risk of developing CHD.

Scientists monitored the effect of five of these drugs on one person over 10 years, the results are shown in Figure 1 below.

The labelled arrows show when each new treatment was started.

hdl-in-blood_graphFigure 1

Compare the effectiveness of the treatments in reducing the risk of CHD.

(4)
1d
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4 marks

Statins are a commonly prescribed drug which can reduce an individual’s risk of developing Coronary Heart Disease (CHD).

Discuss the use of statins to prevent CHD.

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2a
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4 marks

Bacteria can be cultured within a lab for research purposes. This is a key step in the development of new medicines.

Describe and explain how a scientist should prepare a bacterial culture on a Petri dish.

2b
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6 marks

A scientist tested different antibiotics to determine their effectiveness on a bacterial colony growing on a Petri dish. She soaked small paper discs in different antibiotics and placed them on the Petri dish where the bacterial colony was growing. Paper disc A was not soaked in anything.

The image in Figure 1 shows the results she obtained.5-3-edexcel-gcse-5-3h-sq-q2-inhibition-zone

Figure 1

(i)
What was the purpose of the scientist testing the effect of disc A?

(1)

(ii)
The diameter of the inhibition zone for disc E was measured as 2.1cm.
Calculate the inhibition zone for disc E. Include the correct units in your answer.

Give your answer to 2 decimal places.

Use π = 3.14

(5)

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3a
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1 mark

Having a high proportion of body fat can lead to a person becoming obese. People with a BMI over 30 are considered to be obese.

Suggest why BMI is not always an accurate indication of health and body fat levels.

3b
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9 marks
(i)
Figure 1 shows the incidence rate of different heart-related health issues compared to their BMI classification. 5-3-edexcel-gcse-5-3h-sq-q3-chd-v2
Figure 1

Use the figures to calculate how many times more likely you would be to have heart failure when severely obese compared to being healthy weight.

Give your answer to 3 significant figures.

(2)

(ii)
Explain why someone who is severely obese is more likely to have heart failure than someone who is a healthy weight.

(4)

 

(iii)
There are other risk factors that can contribute to a person developing cardiovascular disease.

Suggest and explain another how one other risk factor can contribute to the development of cardiovascular disease.

(3)

3c
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4 marks

The information in Table 1 below shows some information about two types of treatment for cardiovascular disease.

Table 1

Use of stents Heart bypass surgery
Minimally invasive operation Surgery requires general anaesthetic
Typically one is fitted at a time Multiple arteries can be unblocked in a single surgery
Straight-forward procedure and relatively short recovery time There can be complications post-surgery including infection
Required to take anti-clotting medication following surgery Required to take statins to lower blood cholesterol levels following surgery

Explain why a patient might opt for a stent rather than bypass surgery to treat cardiovascular disease.

Use information in the table above and your own knowledge in your answer.

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4a
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2 marks

Monoclonal antibodies is the term used to describe many identical antibodies made by identical immune cells. These have various uses in medicine and research. 

Number the steps 1-5 in Table 1 below to describe how monoclonal antibodies are produced.

Table 1

The mouse produces lymphocytes that make antibodies complementary to the antigen that has been injected  
The lymphocyte is fused together with a cancer cell is now known as a hybridoma  
A particular antigen is injected into a mouse  
The lymphocyte that makes the antibodies is removed from the mouse  
The hybridoma can now produce many of the desired antibody  
4b
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4 marks

Monoclonal antibodies are now routinely used to treat a number of diseases, including Crohn’s disease, which is a condition where parts of the digestive system become inflamed due to a chemical called TNF. TNF is a small protein known as a cytokine, which, when released, trigger an immune response which ultimately leads to inflammation.

(i)
Monoclonal antibodies can bind to TNF to inhibit its activity. 

Explain how this works to treat the symptoms of Crohn’s disease. 

(2)

(ii)
Suggest why the monoclonal antibodies bind to the TNF molecules but not normal body cells.

(2)

4c
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4 marks

Evaluate the use of monoclonal antibodies in treating diseases.

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5a
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4 marks

Before medication can be manufactured and sold on a large scale, the drugs go through a rigorous trial process.

(i)
Explain why the drugs need to go through a clinical trial process before being given to patients.

(2)

Table 1 below shows the number of drugs that pass through each stage of the clinical trials.

Table 1

Stage of process Number of drugs passing each stage
Phase 1 to Phase 2 63200
Phase 2 to to Phase 3 19402
Phase 3 to regulatory authority 11273
Regulatory authority to approval 9616

(ii)

Calculate the percentage decrease of the number of drugs passing through
Phase 1 to Phase 2 and those that are approved.

Give your answer to 3 significant figures.

(2)

5b
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4 marks

As with other drugs, antibiotics must go through a multi-step clinical trial process. 

Some researchers are trying to create alternative antibiotics to those currently being mass-produced. One possible source of antibiotics can be found in natural substances that have antimicrobial properties.

The graph in Figure 1 shows the effectiveness of two different types of herbs when used to kill bacteria: coriander and garlic. Also included in the graph is a control substance and a combination of both herbs together.l2jLIMc3_5-3-edexcel-gcse-5-3h-sq-q5-herbsedexcel-gcse-5-3h-sq-q5-herbs

Figure 1

Describe the effectiveness of using different types of herbs as an antimicrobial substance.

Use figures from the graph in your answer.

5c
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4 marks

The use of natural antimicrobial substances to destroy unwanted bacteria has increased in recent years. Some bacteria have become resistant to commonly used antibiotics, and therefore alternatives such as herbs are being explored. 

Use your knowledge of natural selection to explain why some bacteria are becoming resistant to antibiotics.

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