Cost-effectiveness Pharmacoeconomic Study of a Standardized Multidisciplinary Weight Loss Method (PronoKal® Method) to Improve the Health Condition of Obese Patients With Associated Comorbidities
Conditions: Obesity, Obese
Sponsor: Protein Supplies SL

PRONOCOST Study 
Cost-effectiveness pharmacoeconomic study of a 
standardized multidisciplinary weight loss method 
(PronoKal® Method) to improve health condition of 
obese patients with associated comorbidities.  
Prospective registry of obese patients with comorbidities under a standardized 
multidisciplinary weight loss method  
Protocol code: PRO-COST-2016-02 
(Version 10.0, 25 October 2017) 
Coordinator: 
Dr. Lucio Criado 
Clinical Medicine Specialist 
Principal investigator: 
Dr. Rosana Cafardo 
Italian Hospital of Buenos Aires 
CABA 

PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a standardized multidisciplinary 
weight loss method (PronoKal® Method) to improve health condition of obese patients with associated 
comorbidities. 
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Version 10.0, 25 October 2017 
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INDEX 
1. SUMMARY ...................................................................................................................................... 4
1.1. Identification of the study ....................................................................................................... 4 
1.2. Type of study ........................................................................................................................... 4 
1.3. Sponsor .................................................................................................................................... 4 
1.4. Study Coordinator ................................................................................................................... 4 
1.5. Principal investigator .............................................................................................................. 4 
1.6. Study locations ........................................................................................................................ 4 
01.7. Primary objective .................................................................................................................. 4 
1.8. Secondary objectives ............................................................................................................. 5 
1.9. Follow-up and duration of the study ..................................................................................... 5 
1.10. Schedule ................................................................................................................................ 5 
2. INTRODUCTION ............................................................................................................................ 6
3. STUDY OBJECTIVES ................................................................................................................... 8
3.1. Primary objective .................................................................................................................... 8 
3.2. Secondary objectives ............................................................................................................. 8 
4. STUDY DESIGN ............................................................................................................................ 8
5.
STUDY POPULATION .............................................................................................................. 8
5.1. Inclusion criteria ...................................................................................................................... 8 
5.2. Exclusion criteria ..................................................................................................................... 9 
5.3. Number of patients ................................................................................................................. 9 
6.
TREATMENT DESCRIPTION .................................................................................................. 9
7.
STUDY PROCEDURES .......................................................................................................... 11
7.1. 
Start of study ..................................................................................................................... 11 
7.2. 
Follow-up period ............................................................................................................... 11 
7.3. 
Duration of study ............................................................................................................... 13 
8.
SOURCE OF INFORMATION AND DATA MANAGEMENT. ............................................ 13
8.2. 
Monitoring .......................................................................................................................... 13 
9.
ENDPOINTS ............................................................................................................................. 14
9.1. 
Primary endpoints ............................................................................................................. 14 
9.2. 
Secondary endpoints ....................................................................................................... 14 
10.
STATISTIC ANALYSIS ........................................................................................................ 14
10.1. 
Descriptive statistics ..................................................................................................... 14 
10.2. 
Analysis of objectives ................................................................................................... 14 
11.
RECORDING ADVERSE REACTIONS ............................................................................ 15
12.
ETHICAL ASPECTS ............................................................................................................ 16
12.1 General .................................................................................................................................. 16 

PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a standardized multidisciplinary 
weight loss method (PronoKal® Method) to improve health condition of obese patients with associated 
comorbidities. 
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Version 10.0, 25 October 2017 
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12.2. Informed consent ................................................................................................................ 16 
12.3. Confidentiality of data ........................................................................................................ 16 
13. 
BIBLIOGRAPHY ................................................................................................................... 16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a standardized multidisciplinary 
weight loss method (PronoKal® Method) to improve health condition of obese patients with associated 
comorbidities. 
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Version 10.0, 25 October 2017 
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1. SUMMARY 
1.1. Identification of the study 
Title of study: PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a 
standardized multidisciplinary weight loss method (PronoKal® Method) to improve 
health condition of obese patients with associated comorbidities.  
Protocol code: PRO-COST-2016-02 
1.2. Type of study 
Prospective, observational, multicenter study based on a registry of patients with 
obesity and associated comorbidities undergoing a standardized multidisciplinary 
weight loss method with a 2-year follow-up. 
1.3. Sponsor 
PNKDIET, S.L.U.  
C/ Roger de Llúria, 58.  
08009 Barcelona  
Tel: +34 934 877 589.  
1.4. Study Coordinator 
Dr. Lucio Criado 
Clinical Medicine Specialist Accredited by the National Academy of Medicine.  
CABA. 
1.5. Principal investigator 
Dr. Rosana Cafardo 
Clinical Medicine Service of the Italian Hospital of Buenos Aires. 
CABA- Argentina 
1.6. Study locations 
Clinical medicine outpatient facilities. Italian Hospital of Buenos Aires    
Private consultation offices 
01.7. Primary objective 
To assess the Cost-effectiveness of a standardized weight loss method (Pronokal® 
Method) treatment to improve the health condition of obese patients with comorbidities 
and thereby reduce healthcare expenditure (pharmacological treatment, incidence of 
complications, use of health resources) and work absenteeism.  

PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a standardized multidisciplinary 
weight loss method (PronoKal® Method) to improve health condition of obese patients with associated 
comorbidities. 
PRO-COST-2016-02 
Version 10.0, 25 October 2017 
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1.8. Secondary objectives 
 Assess short and long-term weight loss and waist circumference reduction 
 Assess the degree of clinical and laboratory improvement of cardiovascular risk 
factors (HTN, diabetes, dyslipidaemia) associated with weight loss  
 Evaluate patient quality of life improvement in relation to weight loss 
 Assess the tolerability and safety of the weight loss treatment. 
1.9. Follow-up and duration of the study 
Patients will be monitored for 2 years.  
1.10. Schedule 
Start of study: April 2017 
End of Recruitment Period: June 2018 
End of study: June 2020 

PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a standardized multidisciplinary 
weight loss method (PronoKal® Method) to improve health condition of obese patients with associated 
comorbidities. 
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Version 10.0, 25 October 2017 
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2. INTRODUCTION 
Obesity is a complex medical problem, which has been declared a global epidemic by 
the World Health Organization. The increase in its prevalence implies significant rises 
in healthcare system costs, both directly and indirectly, together with a quality of life 
deterioration.  
In Argentina, as in most countries, obesity is a problem that affects more and more 
people. According to data published by WHO1, the prevalence of obesity in the country 
has increased from 23.7% of the adult population in 2010 to 26.5% in 2014. 
It is a multifactorial disease that can be associated with multiple comorbidities as it acts 
as a risk factor for the development of pathologies such as cardiovascular disease, 
type 2 diabetes (T2DM), various cancers, respiratory problems and arthritis2. 
Obesity generates a very high socioeconomic and disease burden, which compromises 
both the health of the population and public and private finances. The importance of 
treating and preventing obesity lies in reducing the impact of its complications in the 
quality of life and in its economic costs (including comorbidities and premature deaths 
attributable to overweight/obesity) that not only affect healthcare expenditure, but are 
also accompanied by a decrease in labour productivity2.   
Many studies have highlighted the increased costs associated with overweight and 
obesity, and how their progressive incidence suggests that in 15 years, in countries 
such as the United States or the United Kingdom, medical costs associated with the 
combined treatment of obesity and associated preventable diseases will increase by 
$48-66 billion/year and by £1.9-2 billion/year respectively3. Similarly, in a health survey 
in which data were collected from more than 17,000 people, an association between 
BMI and the annual rates of outpatient visits and hospitalization days, annual cost of 
visits, ambulatory pharmacy and laboratory services expenditure, and the total cost of 
health care (including inpatient and outpatient) was confirmed. Specifically, the total 
annual mean costs were 25% higher among subjects with a BMI of 30 to 34.9 kg/m2 
compared to a BMI of 20 to 24.9 kg/m2 and 44% higher among those with a BMI of 35 
kg/m2 or higher. These costs were mainly explained by the presence of coronary 
disease, hypertension and diabetes4. Other studies have also shown the impact of 
obesity and its complications on productivity. For example, a European study in 
Sweden found that obese subjects not only had a significantly higher healthcare 
expenditure on medication, but also that the number of sick leave days was 1.4 to 2.4 
times higher and their probability of getting a disability pension multiplied from 1.5 to 
2.8 times when compared to normal weight people 5.      
Obesity has biological, physiological, psychological, environmental and economic 
basis, which operate at several levels, including molecular and genetic mechanisms. 
Consumption habits of sugars and fats could be due to metabolic imbalances. The 
glycaemic index of foods, differences between individuals to metabolize glucose and 
insulin resistance are considered physiological causes of obesity. Psychological 
causes point to addictive behavioural patterns. Environmental causes emphasize 

PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a standardized multidisciplinary 
weight loss method (PronoKal® Method) to improve health condition of obese patients with associated 
comorbidities. 
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interpersonal influences and social norms and standards. And for their part, economic 
factors are related to the living conditions of individuals who suffer from weight 
problems and food prices. Thus, the increase in weight can be attributed to the 
consumption of foods high in calories added to increasingly sedentary life patterns. 
The standardized multidisciplinary method under study (PronoKal® Method) is a 
personalized weight loss program under medical supervision. Its purpose is to maintain 
the body's weight through food re-training and the continued support of a team of 
dietician-nutritionists. 
Based on a protein diet, this method is developed according to the characteristics of 
the patient and contemplates the participation of a multidisciplinary team that includes 
medical control, dietary-nutritional monitoring, physical activity and emotional support. 
Thus, the aim is, on the one hand, to produce rapid weight loss, especially at the 
expense of fat mass, and on the other hand to achieve a long-term maintenance of the 
results obtained. 
Thus, in addition to a dietary pattern, the method contemplates other factors involved in 
the pathophysiology of obesity, such as nutritional education, physical activity and 
emotional support, all of which must be combined under medical supervision to ensure 
a safe clinical progression of the patient. 
In addition to weight loss, other aspects need to be modified in the treatment of the 
obese patient, so that appropriate behaviours are adopted, resulting in the 
maintenance of the correct weight. 
The basic pillars for the treatment of obesity are changes in lifestyle, including a dietary 
plan, adjustment of physical activity and emotional support. Thus, the management of 
obesity requires a multidisciplinary approach that adapts to the characteristics of the 
patient and allows greater effectiveness in the long term and the optimization of 
healthcare resources used in the fight against obesity. 
Under these premises, the clinical application of the method under study is established 
through the intervention of a Multidisciplinary Specialist Team: 
1. Doctor: clinical assessment, treatment prescription and patient follow-up.  
2. Physical activity: guidance and advice to perform adequate physical activity, 
aimed at increasing caloric expenditure and re-adjusting the energy balance. 
3. Dietitians: accompany and advise on nutrition and food choices throughout the 
treatment. 
4. Psychological support: reinforcement of the patient's psychological status 
contributing to boost the patient's motivation in order to reach his/her short, 
medium and long-term goals. 
The aim of this standardized multidisciplinary method is to decrease the weight of 
obese patients, which is expected to improve the comorbidities associated with obesity  

PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a standardized multidisciplinary 
weight loss method (PronoKal® Method) to improve health condition of obese patients with associated 
comorbidities. 
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Version 10.0, 25 October 2017 
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The present study is designed to make a Cost-effectiveness assessment of the 
standardized multidisciplinary weight-loss treatment (PronoKal® Method) in obese 
patients with associated comorbidities, in order to improve the subjects' health 
condition, healthcare expenditure and work absenteeism as a consequence of their 
comorbidities. 
 
3. STUDY OBJECTIVES 
3.1. Primary objective 
To assess the Cost-effectiveness of a standardized weight loss method (Pronokal® 
Method) treatment to improve the health condition of obese patients with comorbidities 
and thereby reduce healthcare expenditure (pharmacological treatment, incidence of 
complications, use of health resources) and work absenteeism.  
3.2. Secondary objectives 
 
Assess short and long-term weight loss and waist circumference reduction 
 
Assess the degree of clinical and laboratory improvement of cardiovascular risk 
factors (HTN, diabetes, dyslipidaemia) associated with weight loss  
 
Evaluate patient quality of life improvement in relation to weight loss 
 
Assess the tolerability and safety of the weight loss treatment. 
 
4. STUDY DESIGN 
Prospective, observational, multicenter study based on a registry of patients with 
obesity and associated comorbidities undergoing a standardized multidisciplinary 
weight loss method with a 2-year follow-up. 
No randomization or administration of drug treatment is intended as a consequence of 
the patient's participation in the study. 
 
5. STUDY POPULATION 
Obese patients with obesity-associated comorbidities treated with the standardized 
multidisciplinary weight loss method (PronoKal® Method).   
5.1. Inclusion criteria 
 
Patients of both sexes 18 years of age or older 
 
Patients with overweight or obesity (BMI> 30 kg/m2) with at least one or more of the 
following comorbidities associated with obesity:  

PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a standardized multidisciplinary 
weight loss method (PronoKal® Method) to improve health condition of obese patients with associated 
comorbidities. 
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 Type 2 diabetes mellitus 
 Arterial hypertension 
 Dyslipidemia 
 Hyperuricemia 
Those who are under pharmacological treatment with two or more drugs (oral 
antidiabetic 
and/or 
lipid-lowering 
agents 
and/or 
antihypertensive 
and/or 
hypouricemic agents) 
 
Patients who agree to attend the follow-up visits at the Pronokal centre, in Buenos 
Aires.  
 
Patients who agree to participate and provide a signed informed consent  
5.2. Exclusion criteria 
 
Patients who do not sign the informed consent  
 
Pregnant or breastfeeding patients.  
 
Patients with severe eating disorders, alcoholism, or substance abuse.  
 
Patients with severe psychological disorders (e.g., schizophrenia, bipolar 
disorder).  
 
Patients with liver failure.  
 
Patients with kidney failure.  
 
Patients with type 1 DM or insulin-dependent, or currently under insulin 
treatment, or candidates for insulin treatment in a short period of time.  
 
Patients with obesity caused by other endocrine diseases (except type 2 DM).  
 
Patients with blood disorders.  
 
Patients with cancer.  
 
Patients with cardiovascular or cerebrovascular disease (heart rhythm 
disorders, recent infarction [<6m], unstable angina, decompensated heart 
failure, recent stroke [<6m]).  
 
Patients with renal lithiasis.  
 
Patients with cholelithiasis.  
5.3. Number of patients 
Expected number of subjects is 200 patients. Subjects who initiate the multidisciplinary 
weight loss treatment during the study inclusion period, meet the inclusion and 
exclusion criteria, and agree to participate and sign the informed consent will be 
included in the study.  
 
6. TREATMENT DESCRIPTION  

PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a standardized multidisciplinary 
weight loss method (PronoKal® Method) to improve health condition of obese patients with associated 
comorbidities. 
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by dietitians/nutritionists who help control the patient's progress (with continuous on-
site and/or telephone follow-up over the 2 years of treatment) and a team of 
psychological counselling professionals and experts in physical activity. 
 
7. STUDY PROCEDURES 
7.1. Start of study 
The investigating physician will be responsible for assessing the appropriateness of the 
treatment for each patient, regardless of their participation in this study.  
Patients will be recruited consecutively as they go to the clinic and are prescribed 
treatment with the standardized multidisciplinary method. Before being included, the 
investigator must check the inclusion and exclusion criteria, and obtain their informed 
consent.  
7.2. Follow-up period 
The expected follow-up period for each patient will be 2 years from the time of 
inclusion, recording data during the weight loss and maintenance periods. The registry 
of patient data for this study will be made by the doctor and the dietitians/nutritionists 
who will regularly see the patient in the face-to-face visits at the Pronokal centre. For 
this, a specific form will be designed in which information about the variables to be 
studied will be collected. 
Before starting treatment with the standardized multidisciplinary method and its 
inclusion in the study, the physician will have performed a first patient pre-inclusion visit 
(day -15) to request complementary tests (laboratory and ECG) and rule out the 
existence of contraindications to the ketogenic diet part of the weight loss program.   
The study will begin with the baseline visit (day 0) in which the inclusion and exclusion 
criteria will be confirmed, the signing of informed consent will be obtained and the 
multidisciplinary treatment will be prescribed, followed by 6 control visits: 2 visits during 
the ketogenic stage (1-month after the start and at the end of ketosis), 2 visits during 
the physiological adaptation phase (at 4 or 5 months and at the end of stage 2) and 2 
follow-up visits during the maintenance up to the 2-year completion. Regardless of the 
visits established in this protocol, the doctor will make as many visits as he/she deems 
necessary for good patient control.  
On the other hand, dietitians/nutritionists, according to the methodology of the program, 
will carry out a face-to-face follow-up of the patient, which will be fortnightly during the 
ketogenic diet, monthly during the physiological adaptation of stage 2 and quarterly or 
semi-annual during the maintenance stage.  

PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a standardized multidisciplinary 
weight loss method (PronoKal® Method) to improve health condition of obese patients with associated 
comorbidities. 
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Version 10.0, 25 October 2017 
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In the follow-up visits - Recorded by the doctor. In the regular check-ups throughout 
the course of treatment, the physician will record: any discomfort or side effect related 
to weight loss treatment and whether there has been any change in the comorbidities 
associated with obesity (laboratory results, medication, complications, etc.). At the end 
of each stage the doctor will assess the patient's quality of life through a questionnaire. 
In the follow-up visits - Recorded by dietitians/nutritionists. During the interviews 
that the dietitians/nutritionists will have with the patients, and parallel to the doctor's 
records, the following details will be recorded:  
 
Clinical data: anthropometric data and blood pressure  
 
Medication changes 
 
Onset of complications (e.g., hypertensive crisis, ...) 
 
Hospital admissions 
 
Work absenteeism: number of days and cause.... 
In case of early withdrawal from the study, the doctor will write the dropout date and the 
reason, in study completion form.  
7.3. 
Duration of study 
For each patient initiating treatment, a minimum follow-up period of 2 years will be 
observed. 
 
8. SOURCE OF INFORMATION AND DATA MANAGEMENT. 
8.1. Source of information 
The information for this study will be obtained from the patient's medical records and 
the interview that the physician and dietitians/nutritionists carry out with the patient. All 
information will be recorded on the forms designed for this purpose (Annex 3) and 
subsequently submitted to the coordinating center, prior express authorization of the 
patient by signing the Informed Consent, for its statistical analysis. 
The corresponding data will be saved in a file owned by PronoKal Group®, who will 
manage the information according to Organic Law 15/1999 relative to Protection of 
Personal Data.  
8.2. Monitoring 
In this study, a remote monitoring of the inclusion and follow-up of patients will be 
carried out by: 

PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a standardized multidisciplinary 
weight loss method (PronoKal® Method) to improve health condition of obese patients with associated 
comorbidities. 
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Responsible of Monitoring  
CROSSDATA - Punta Alta 
Enric Granados 145, 2º-1º 
08008 Barcelona  
Tel. +34 935 177 609 
 
9. ENDPOINTS  
9.1. Primary endpoints  
The primary variables to be recorded for the study objectives are:  
 
Consumption of health resources: visits, laboratory controls, admissions ... 
 
Changes in pharmacological treatment 
 
Work absenteeism 
9.2. Secondary endpoints  
 
Body weight and waist circumference 
 
Changes in clinical parameters: glycaemic profile, lipid profile, blood pressure  
 
Score in the SF-12 quality of life questionnaire 
 
Onset of side effects  
 
Onset of serious adverse reactions during the protein diet's follow-up. 
 
10. STATISTIC ANALYSIS 
10.1. Descriptive statistics 
Descriptive statistics will be made of all the variables collected in the Case Report 
Form, building frequency tables for the nominal-type variables and measurements of 
central tendency and dispersion for continuous variables. The 95% confidence intervals 
(95% CI) will be estimated for the latter.  
10.2. Analysis of objectives  
The primary objective analysis will include:  
 Costs of weight loss treatment estimated from the cost of: protein products and 
dietary supplements + number of control visits + number of laboratory tests 
performed 
 Healthcare expenditure estimated as the sum of the following costs: 
pharmacological 
treatment 
of 
associated 
comorbidities, 
incidence 
of 

PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a standardized multidisciplinary 
weight loss method (PronoKal® Method) to improve health condition of obese patients with associated 
comorbidities. 
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complications (visits to his/her primary care physician, a specialist or 
emergency 
department for 
acute 
complications, 
treatment 
of 
acute 
complications, number of hospital admission days, antibiotic treatment), 
consumption of health resources (visits to the general practitioner, visits to 
specialists, laboratory tests)  
 Work absenteeism, estimate of the number of work leave days + hours of work 
absenteeism due to health problems or medical visits.   
In order to evaluate if the weight loss treatment is improving the health of patients and 
reducing health expenditure and absenteeism, the healthcare expenses and work 
absenteeism estimated from the doctor's records corresponding to the 6 months prior 
to the initiation of the weight loss treatment will be compared with data recorded at 
follow-up visits over the 2-year follow-up. Likewise, the doses and number of drugs 
required by patients for the treatment of their comorbidities before the weight loss and 
at the control visits during weight loss and up to completing the 2 years of follow-up will 
be compared.   
As secondary objectives, the efficacy of the weight loss treatment will be studied by 
comparing the anthropometric parameters of the initial visit with those of the follow-up 
visits (weight, body mass index and waist circumference). Likewise, any improvement 
in laboratory parameters and blood pressure during the follow-up will be studied. 
Changes in quality of life scores (SF-12) will also be assessed between the initial visit 
and the end of each treatment stage.   
For all objectives, the comparisons between qualitative variables will be made using 
the Chi square test or the Fisher exact test, and the comparison between quantitative 
variables will be performed using the Student's t-test (in the case of 2 groups) or by the 
one-way ANOVA test (for 3 or more groups). If the conditions for the Student's t-test or 
the Anova test are not met, the non-parametric Mann-Whitney U test (2 groups) or the 
Kruskal-Wallis test (for 3 more groups) will be used.  
Safety and tolerability will be analysed by descriptive statistics of all side effects or 
adverse reactions reported by patients throughout the study. 
For all tests, the significance level will be set at p <0.05.  
 
11. RECORDING ADVERSE REACTIONS 
During the entire follow-up period, the physician should report any suspicion of a 
serious adverse reaction observed in the patient under treatment by completing a 
Serious Adverse Reaction Report form, forwarding it to the coordinating center (Annex 
5). 

PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a standardized multidisciplinary 
weight loss method (PronoKal® Method) to improve health condition of obese patients with associated 
comorbidities. 
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12. ETHICAL ASPECTS 
12.1 General 
This study will be carried out in accordance with current regulations, international 
accepted ethical standards of Good Clinical Practice (CPMP/ICH/135/95) and the 
principles established in the latest version of the Declaration of Helsinki. 
12.2. Informed consent 
Prior to inclusion in the study, the study doctor should provide the patient with 
information about the study (Annex 1), propose participation in the same, answer any 
questions and request the completion of the informed consent (Annex 2), which he/she 
will keep in his/her own files.  
12.3. Confidentiality of data 
The data of the different participating subjects will become part of a totally confidential 
electronic file owned by Pronokal Group. 
 
13. 
BIBLIOGRAPHY 
                                                          
1 http://apps.who.int/gho/data/view.main.2480C?lang=en 
2 J Elgart, G Pfirter, L Gonzalez, J Caporale, ACormillot, ML Chiappe,J Gagliardino. La 
obesidad en Argentina: epidemiología, la morbimortalidad y el impacto económico. Rev Argent 
Salud Pública, 2010; 1(5):6-12. 
3 AUWang YC, McPherson K, Marsh T, Gortmaker SL, Brown M. Health and economic burden 
of the projected obes ity trends in the USA and the UK. Lancet. 2011;378(9793):815. 
4 Quesenberry CP Jr, Caan B, Jacobson A. Obesity, health services use, and health care costs 
among members of a health maintenance organization. Arch Intern Med. 1998;158(5):466. 
SERIOUS ADVERSE REACTION: refers to any adverse reaction that can be classified in 
one or more of the following categories: 
- 
Fatal 
- 
Life-threatening 
- 
Causes persistent or significant disability 
- 
Causes hospitalization or prolongs hospital stay 
Congenital anomalies/birth defects and serious adverse clinical consequences associated 
with use under conditions other than those set out in the Summary of Product Characteristics 
(SmPC), overdose or abuse are also included. 
Medical judgment should be implemented when deciding whether an event or reaction is 
serious in other situations. Major adverse reactions or events that do not pose an immediate 
danger to life or cause death or hospitalization but which may endanger the patient should 
be considered serious. 

PRONOCOST study. Cost-effectiveness pharmacoeconomic study of a standardized multidisciplinary 
weight loss method (PronoKal® Method) to improve health condition of obese patients with associated 
comorbidities. 
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5 AUNarbro K, Agren G, Jonsson E, Näslund I, Sjöström L et al. Swedish Obese Subjects 
Intervention Study. Pharmaceutical costs in obese individuals: comparison with a randomly 
selected population sample and long-term changes after conventional and surgical treatment: 
the SOS intervention study. SOArch Intern Med. 2002;162(18):2061. 
 
 
 
 
 
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