Keywords
In Vitro Fertilization, Depression, FertiQoL, Supportive care, Clinical Pharmacist.
Infertility affects approximately 10-15% of married individuals, and may trigger various emotional reactions. Females undergoing in vitro fertilization (IVF) are more susceptible to experiencing depression. This study aims to assess the influence of pharmacist counseling on quality of life, depression scores, and pregnancy rates among infertile females undergoing IVF treatment.
The research examined women who visited the infertility clinic at Kamal Al-Samaraie Hospital in Baghdad, Iraq to achieve pregnancy. These individuals were separated into a control group and an intervention group. The intervention group received an educational program consisting of five visits, while the control group got a conventional hospital procedure. The present research evaluated the quality of life-related to fertility using the FertiQoL (Fertility Quality of Life) questionnaire. It examined the participants’ depression levels using the CES-D (Center for Epidemiologic Studies Depression) scale. These assessments were conducted at the commencement and conclusion of the in vitro fertilization (IVF) cycle.
The present research included 150 women diagnosed with infertility, whose average age was 30.32 ± 5.64 years. The participants had a mean body mass index (BMI) of 27.12 ± 3.57. No statistically significant difference was seen in the FertiQoL evaluation scores between the control and intervention groups at the beginning of the study. The FertiQoL, assessed at the end of the trial, exhibited a statistically significant increase in the interventional group, with a P-value of 0.025. The prevalence of Depression risk patients decreased from 83% to 69%, and the interventional group exhibited a substantially greater proportion of favorable pregnancy outcomes (48%) compared to the control group (29.3%).
Infertile women who undergo IVF operations have higher rates of depression. Depression may be reduced, and quality of life improved with education and supportive counseling. Pregnancy rates rise as a result of clinical pharmacist counseling.
This study was registered on Clinical Trials.gov (NCT06022640).
In Vitro Fertilization, Depression, FertiQoL, Supportive care, Clinical Pharmacist.
Infertility impacts around 10-15% of married individuals, including males and females, and can result in a range of emotional responses such as anxiety, distress, pain, and disappointment.1 This significant life event has the potential to impact several dimensions of a couple’s existence.2 Preconception counseling is an essential need for the initiation of infertility therapy, as it encompasses a comprehensive assessment of several aspects, including medical, social, genetic, environmental, and occupational factors, which have an impact on both fertility and the overall well-being throughout pregnancy.3 Depression is a prevalent concern among women experiencing infertility, and pharmacists assume a pivotal role in the provision of treatment for those affected by depression.4,5
The underlying cause of female infertility remains unclear; however, a significant proportion of cases (81%) may be attributed to ovulatory problems, endometriosis, pelvic adhesions, tubal obstruction, other tubal abnormalities, and hyperprolactinemia.6,7 The decline in fertility is influenced by advancing age, and the incidence of infertility due to age increases as the reproductive lifespan diminishes. Infertility treatment aims to address remediable factors and overcome refractory ones.8,9 The fundamental concepts of care for couples experiencing infertility include the identification and assessment of the underlying causes, as well as the subsequent implementation of appropriate treatment strategies.10 Additionally, recommendations may be made about behavioral modifications to enhance fertility, such as smoking cessation and minimizing exposure to potentially detrimental drugs.11
Assisted reproductive technology (ART) is a medical intervention to address infertility, including therapeutic approaches that include ova and sperm. In assisted reproductive technology (ART), in vitro fertilization (IVF) is usually considered the most productive approach.12 in vitro fertilization (IVF) is widely recognized as a very effective treatment for infertility, yet it sometimes requires numerous rounds of egg retrieval and embryo transfer.13 This treatment has shown efficacy in addressing unexplained infertility and conditions such as blocked or damaged fallopian tubes, hereditary abnormalities, uterine fibroids in women, ovulation difficulties, early ovarian failure, and cases where ovaries have been surgically removed.14
The process of IVF entails ovarian stimulation, which encompasses the administration of fertility medications to induce the development of eggs and control the operation of ovulation.15 Emotional alterations often occur among individuals undergoing in vitro fertilization (IVF), particularly those with a history of mental illness, experienced miscarriage, faced a prolonged period of infertility or received a conclusive medical diagnosis.16 The stress levels of IVF patients tend to rise as the intensity and duration of treatment grow, resulting in higher stress levels compared to women in the early stages of their infertility examination.17
The experience of infertility and the administration of corresponding drugs may elicit significant psychological distress among patients, particularly those who have undergone several in vitro fertilization rounds without achieving successful outcomes.18 Patients may lack familiarity with self-injecting gonadotropins, using hormone supplements, and adhering to other essential therapies required for ovulation induction cycles.19 Research indicates a negative association between depression and in vitro fertilization (IVF) conception rates. However, the specific influence of depression on emotional discomfort remains unknown.20
Grief reactions are often reported in couples who are facing infertility. However, these usual grief reactions may develop into pathological grieving, characterized by prominent melancholy symptoms.21 Infertility-related depression in women varies between 10% and 25%, with women exhibiting significant depressive symptoms at two to three times greater rates than males.22,23 The presence of depression has been shown to have adverse effects on several aspects of therapy, follow-up, and future perspective, as well as the strength and longevity of the relationship between the afflicted pair.24
Pharmacists are crucial in providing education and supportive care for individuals suffering from depression.25 They provide valuable guidance, suggestions, and counseling about drugs while monitoring patients for drug-related issues and evaluating patient adherence to prescribed treatments.26 Pharmacists’ professional role includes pharmaceutical care concepts, transitioning them from their conventional role as mere dispensers of medications to being integral members of the healthcare team.27 The primary objective of patient-centered treatments is to enhance therapeutic results via identifying, preventing, and managing drug-related issues, promoting appropriate medication use, and providing general health education.28 In Iraq, it has been observed that a significant number of chronic illnesses are not effectively addressed via the collaborative efforts of healthcare professionals, including pharmacists, despite their recognized position within the broader healthcare framework.29 It is important to enhance the professional growth of pharmacists to enable them to carry out their duties proficiently. The concept of care centers on cultivating the pharmacist-patient relationship and strengthening the therapeutic result by active engagement in the treatment approach.30
It has been shown that collaborative counseling may lead to a 3.6-fold decrease in stress levels among infertile women undergoing in vitro fertilization (IVF) compared to a control group. Psychotherapy emerges as a compelling treatment option due to its efficacy in enhancing patients’ likelihood of achieving pregnancy.31 Psychological counseling, interpersonal therapy, and behavioral activation are often used as the first treatment modalities for depression.32 Several studies have shown that infertile women seeking to undergo in vitro fertilization (IVF) may have unsuccessful outcomes and fail to achieve pregnancy due to pre-existing depressive symptoms in the patient.33,34 Consequently, it is essential to implement health education and raise awareness of the need to ensure a satisfying state before undergoing surgery, with a particular emphasis on women due to their heightened vulnerability to this kind of depression in comparison to males.35
The primary goal of this study was the assessment of clinical pregnancy rates as a measure of the result of in vitro fertilization cycles after the introduction of educational support program by the clinical pharmacist. Secondary outcome measures were the completion of The Centre for Epidemiological Studies Depression Scale (CES-D) and The Fertility Quality of Life Tool (FertiQoL) evaluation by both groups at the beginning and end of the in vitro fertilization process.
The ethics committee of the College of Pharmacy at Mustansiriyah University, Iraq, formally approved the research methodology. Written consent was acquired from every individual enrolled in the study after providing a comprehensive explanation of the study’s objectives and maintaining the confidentiality of patient information.
This study used a prospective two arms parallel-group in an interventional randomized control trial design to examine the effects of an educational support program led by a clinical pharmacist on the pregnancy rate of infertile females who completed in vitro fertilization cycles and had symptoms of depression. Research including a sample of 206 women experiencing infertility and using in vitro fertilization technology (Figure 1). However, 32 participants were excluded from the study because they failed to match the predetermined inclusion criteria. Out of the total sample size of 174 women experiencing infertility, 24 individuals declined participation, while 150 individuals consented to participate in the research, as seen in CONSORT flow diagram below.36 The trial had a total of 75 participants assigned to the intervention group, whereby they were provided with an instructional and supporting program specifically developed by a clinical pharmacist. The intervention group was assisted via a series of five visits, including an initial visit upon admission, subsequent visits for monitoring medication, ovulation, and any negative effects, and visits dedicated to giving emotional support. A follow-up visit was also conducted after the egg harvesting process and embryo transfer. The control group comprised 75 married women experiencing infertility and seeking treatment at the hospital. These women were handled according to the standard practice used by the hospital system.
This research recruited infertile females’ participants seeking pregnancy at the Kamal Al-Samaraie hospital, a government-run infertility facility located in Baghdad, Iraq, from January 1st 2022 to July 1st 2022.
To qualify for inclusion in the research, participants must satisfy certain criteria. These requirements included being a woman experiencing infertility (the inability to conceive after at least one year of marriage). To be within the reproductive age (18-45 years old) and to have the ability to read and understand.
The exclusion criteria for the patients includes those who had experienced past failure of an in vitro fertilization. Morbid obesity (a body mass index (BMI) over 40).37 Individuals under consideration to have mental conditions that necessitate their admittance to a psychiatric institution, or those grappling with addiction or having progressive neurological disorders. Any individual who has a condition that hinders their ability to engage in effective communication due to challenges related to language and hearing.
The primary objective of the research was to examine the correlation between the pregnancy rate of infertile females who underwent in vitro fertilization (IVF) cycles and the presence of accompanying depressive symptoms throughout this process. The CES-D scale was used to evaluate the level of depression in each participant. The CES-D questionnaire is a standardized evaluation consisting of 20 items that prompts individuals to evaluate the frequency with which they experienced symptoms associated with depression over the course of the preceding week.38 The CES-D utilizes cutoff values of 16 or above in order to identify individuals who may be at risk of experiencing clinical depression. Elevated scores are indicative of a greater manifestation of depressive symptoms. The assessment has exceptional levels of sensitivity, specificity, and internal consistency and has been successfully used in many age groups.
The FertiQoL questionnaire is a widely recognized instrument for assessing the quality of life related to fertility. It examines the impact of reproductive challenges on multiple aspects of individuals’ lives, encompassing overall well-being, self-perception, emotional states, interpersonal relationships, familial and social ties, occupational satisfaction, and aspirations for the future. The questionnaire has been translated into a total of 20 languages, which notably includes Arabic.39 The present research evaluated the FertiQoL at two distinct time points: before to the implementation of the management program and subsequent to the completion of embryo transfer.
The intervention that was given was educational that disseminate knowledge related to the issue of infertility. The education interventions consisted of comprehensive information associated with the pathophysiology of infertility, etiological factors, guidelines for therapy, strategies for managing psychological distress, techniques for stress reduction, and encouraging the development of healthy interpersonal connections. The objective of educational interventions is to enhance the health literacy of women experiencing infertility. The instructional materials used in this study were adopted from evidence-based guidelines involving disseminating educational resources focused on psychological assistance for individuals experiencing infertility.40–42
A computerized randomization method was used to allocate patients into two groups in a randomized manner. Following the first interview, the patients were sequentially assigned numbers and then randomized into two groups via the online program Research Randomizer.
The recommended minimum sample size is calculated according to the formula:
Where: z = 1.96 for a confidence level (α) of 95%, p = prevalence of infertility which was reported to be as high as 8.9% among the general population,43 e = margin of error e = 0.05. The minimum sample size was equal to 125.
The data collected was entered into Microsoft Excel 2021 (RRID: SCR_016137) and then inserted into SPSS statistical software/version 26 (RRID: SCR 016479). The Chi-Square Test was performed to determine the significance of relationships between related categorical variables. The independent-sample T-test was used to assess the significance of numerical variables in the intervention and control groups at the beginning and end of the trial in terms of FertiQoL score and depression score. The 95% confidence interval has been set. The P-value of 0.05 was used as the cutoff for significance.
A total of 150 infertile females exposed to IVF procedures were eligible for the study (Table 1).
Characteristic | N | Minimum | Maximum | Mean | SD |
---|---|---|---|---|---|
Age in years | 150 | 19 | 45 | 30.32 | 5.64 |
Duration of marriage in years | 150 | 1 | 12 | 3.74 | 2.17 |
BMI | 150 | 19.5 | 39.5 | 27.12 | 3.57 |
The study found no significant association between group of study and age, duration of marriage and BMI (body mass index) (Table 2).
According to the data shown in Table 3, the average pre-FertiQoL score for the control group is 53.48 ± 13.98, which is statistically insignificant from the average score of 51.66 ± 14.87 for the interventional group (P-value = 0.443). While the FertiQoL measured at post-time (post-FertiQoL) was found to be significantly higher among the interventional group, P-value = 0.025.
Group | N | Mean | Std. Deviation | *p-value | |
---|---|---|---|---|---|
Pre-FertiQoL | Control | 75 | 53.48 | 13.98 | 0.443 (NS) |
Interventional | 75 | 51.66 | 14.87 | ||
Post-FertiQoL | Control | 75 | 53.33 | 13.20 | 0.025 (S) |
Interventional | 75 | 58.47 | 14.51 |
The CES-D provides cutoff scores (16 or greater) that aid in identifying individuals at risk for clinical depression, with good sensitivity and specificity and high internal consistency.44 The cutoff point of 16 was considered to be indicative of mild depression, and the degree of depression was shown to rise as the score increased.45 The percentage of at-risk participants evaluated for depression dropped from 83% at the beginning to 69% at the end of the study, as shown in Figure 2.
The overall risk of depression in the interventional group was considerably reduced compared to the control group at the end of the study, with a P-value of 0.001 (as presented in Table 4).
Time of measurement | Group of study | Risk | No risk | *P-value | ||
---|---|---|---|---|---|---|
N | % | N | % | |||
Start-time | Control | 65 | 86.7% | 10 | 13.3% | 0.273 (NS) |
Interventional | 60 | 80.% | 15 | 20% | ||
End-time | Control | 67 | 89.3% | 8 | 10.7% | 0.001 (S) |
Interventional | 36 | 48% | 39 | 52% |
The interventional group exhibited a significantly greater rate of positive pregnancy (48%) compared to the control group (29.3%), as shown by a P-value of 0.019 (Table 5).
Negative | Positive | *P-value | ||||
---|---|---|---|---|---|---|
N | % | N | % | |||
Group | Control | 53 | 70.7% | 22 | 29.3% | 0.019S |
Interventional | 39 | 52.0% | 36 | 48.0% |
There was no statistically significant difference seen between the pre-FertiQoL and post-FertiQoL scores among the research participants who had a negative pregnancy outcome. The p-values for the two variables were 0.795 and 0.497, respectively. The post-FertiQoL mean score in the interventional group was substantially higher compared to the control group among individuals who had positive pregnancy outcomes P-value = 0.016 (Table 6). A statistically significant difference was seen among participants in terms of their depressive condition after the completion of the IVF cycles, including between those with a positive pregnancy result and those with a negative outcome (Table 7).
Pregnancy status | Time of measurements | Group | N | Mean | Std. Dev. | *P-value |
---|---|---|---|---|---|---|
Negative | Pre FertiQoL | Control | 53 | 54.40 | 14.29 | 0.795 (NS) |
Interventional | 39 | 53.63 | 13.59 | |||
Post FertiQoL | Control | 53 | 53.55 | 13.72 | 0.497 (NS) | |
Interventional | 39 | 55.60 | 14.96 | |||
Positive | Pre FertiQoL | Control | 22 | 51.26 | 13.27 | 0.674 (NS) |
Interventional | 36 | 49.53 | 16.06 | |||
Post FertiQoL | Control | 22 | 52.81 | 12.13 | 0.016 (S) | |
Interventional | 36 | 61.58 | 13.52 |
Pregnancy status | Time of measurement | Depression status | Group | ||||
---|---|---|---|---|---|---|---|
Control | Interventional | ||||||
N | N % | N | N % | *P-value | |||
Negative | Pre CES-D | No risk | 4 | 7.5% | 6 | 15.4% | 0.233 (NS) |
Risk | 49 | 92.5% | 33 | 84.6% | |||
Post CES-D | No risk | 3 | 5.7% | 18 | 46.2% | 0.0001 (HS) | |
Risk | 50 | 94.3% | 21 | 53.8% | |||
Positive | Pre CES-D | No risk | 3 | 13.6% | 6 | 16.7% | 0.757 (NS) |
Risk | 19 | 86.4% | 30 | 83.3% | |||
Post CES-D | No risk | 3 | 13.6% | 20 | 55.6% | 0.002 (HS) | |
Risk | 19 | 86.4% | 16 | 44.4% |
Individuals experiencing difficulties in achieving conception often experience symptoms of despair and anxiety.46 Research has shown that infertile women have emotional issues comparable to those struggling with malignancies.47 Infertility is a widespread public health concern that has many medical, psychological, and social consequences.48 Depression may influence an individual’s cognitive processes, behaviors, emotional experiences, and overall state of health.
We performed a randomized controlled trial to evaluate the impact of supportive and educational intervention on depression scores and pregnancy outcomes in infertile women. The present research reveals that women who are facing infertility issues and actively seeking medical intervention had been in a marital relationship for an average duration of 3.74 ± 2.17 years, with the longest reported duration being 12 years. According to the findings of an earlier study carried out in the Erbil Kurdistan Region of Iraq, it was observed that a majority of 55.5% of women experiencing infertility and actively seeking infertility treatment had been married for a length ranging from 3 to 7 years.49 Based on available research, the average period of infertility in India is around 8.38 years.50 In Korea, this time is estimated to be around four years.51 In Italy, it has been observed that over fifty percent of couples choose Assisted Reproductive Technology (ART) after being married for less than 3 years.52 The observed variations may be attributed to the distinct sociocultural characteristics of each nation.
The objective of this research is to enhance awareness of the fertility-related quality of life among women who are facing infertility and to demonstrate the impact of supportive care on their quality of life. The quality of life experienced by women enduring infertility therapy may be substantially decreased. The quality of life experienced by women enduring infertility therapy may be substantially decreased. This phenomenon has the potential to induce treatment discontinuation and possibly generate resistance against seeking assistance from the patient.53
The present study analyses the quality of life experienced by infertile women in Iraq who receive in vitro fertilization (IVF) treatment. The average FertiQoL score at the beginning of the study (before implementing any interventions) was 53.48 ± 13.98 for the control group and 51.66 ± 14.87 for the intervention group. The baseline mean of all included cases was calculated to be 52.57 ± 14.417. The findings of this study revealed a significant gap in the assessment of quality of life among infertile women compared to a survey conducted in Kazakhstan. In the Kazakh study, 453 infertile women who received IVF treatment reported a FertiQoL score of (59.6 ± 11.5), with a P-value of 0.001.54 The findings presented in research conducted in Germany, Italy, France, Poland, and Taiwan showed substantial and statistically significant variations.55–57 Potential factors contributing to this observed disparity may include elevated living standards and increased accessibility to mental health care within these industrialized nations.
The findings of the comparative analysis conducted on different study groups about FertiQoL indicate that no statistically significant differences were seen during the first assessment. However, it was observed that the intervention group had markedly elevated levels compared to the control group at the end of the study. The observed effect is hypothesized to be attributable to supportive care’s impact on enhancing the experimental cohort’s overall well-being. This finding aligns with previous research on Iranian women experiencing infertility, whereby the group that received counseling had a notably higher average score in terms of quality of life than the control group.58
The research findings indicate that the initial prevalence of depression among all participants included in the study at the beginning of the in vitro fertilization cycle was 83%. The results presented in this research are similar to another study in Kazakhstan, whereby a sample of 304 females experiencing infertility were interviewed across three distinct locations. The results indicated that over 80% of respondents exhibited CES-D scores of 16 or above, indicating a greater susceptibility to the onset of clinical depression. The above rate has decreased to 69% following the implementation of educational interventions and supporting measures for females experiencing infertility after the in vitro fertilization cycle is completed. During the examination of the interventional group’s depression state before and after the in vitro fertilization cycle, it was observed that the prevalence of depression decreased from 80% to 48%.
There was no statistically significant difference in depression scale scores between the control and intervention groups at the beginning of the study (p-value = 0.273). However, at the end of the study, there was a significant difference in depression scale ratings between the two groups (p-value = 0.001). The observed decline may be attributed to the provision of educational and supportive care within the IVF program. This finding is consistent with previous research in which a statistically significant difference in the outcome was observed after the intervention was carried out, providing further support for the present conclusion.59,60 Providing patients with psychological interventions and emotional support is crucial for infertility healthcare professionals.61
The research findings revealed that the favorable conception rate differed between the control and intervention groups regarding IVF outcome rates, with 29.3% and 48%, respectively. The results of this study suggest that the intervention group exhibited a 1.6-fold increase in the likelihood of achieving pregnancy compared to the control group. The findings above were deemed similar to those of another research done in Brazil, whereby the intervention group exhibited a notably higher pregnancy rate (39.8%) compared to the control group 23.2%.62
The intervention group exhibits a greater proportion of positive pregnant women than the control group, with 29.3% and 48%, respectively. Additionally, the overall pregnancy success rate for all participants is 39%. Initially, it was seen that both groups exhibited similar levels of FertiQoL about the outcome of a positive or negative pregnancy test. The female individuals in the intervention group showed a notable enhancement in FertiQoL compared to the control group towards the end of the research. Furthermore, significant variations in pregnancy rates were seen across the groups, with the intervention group exhibiting a greater rate than the control group. Consequently, after providing information and comprehensive assistance, the enhancement of FertiQoL shows a positive correlation with the incidence of successful pregnancies. This is similar to a research study conducted among a cohort of Chinese women receiving their first in vitro fertilization procedure at a specialized reproductive clinic.63
This research has several limitations; the first is related to the measurements used. The present study used self-report measures exhibiting inherent limitations, such as a potential deficiency in self-awareness. Another limitation is the absence of control over individual aspects. Participants may have exaggerated the impact of the intervention due to personal drive, optimism, and related variables. In future research investigations, it is advisable to include pseudo-therapy programs, also called placebo programs, inside control groups to mitigate the influence of anticipation effects. Finally, the participants were recruited from Kamal Al-Samaraie Hospital in Baghdad, Iraq, and had undergone an in vitro fertilization treatment cycle. Researchers should implement programs on additional individuals in other healthcare facilities to broaden the scope of the study’s results.
Infertile women who undergo IVF operations have higher rates of depression. Depression may be reduced, and quality of life improved with education and supportive counseling. Pregnancy rates rise as a result of clinical pharmacist counseling.
Zenodo: The assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: A Randomized Clinical Trial, https://doi.org/10.5281/zenodo.8348310. 64
This project contains the following underlying data:
Zenodo: Trial protocol for the assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: a randomized clinical trial, https://doi.org/10.5281/zenodo.10076029. 65
This project contains the following extended data:
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY).
Zenodo: CONSORT Checklist for ‘The assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: A Randomized Clinical Trial’, https://doi.org/10.5281/zenodo.8348485. 66
Zenodo: CONSORT flow diagram for ‘The assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: A Randomized Clinical Trial’, https://doi.org/10.5281/zenodo.10075894. 36
Trial registration: This study was registered on Clinical Trials.gov (NCT06022640).
The authors express their gratitude to everyone who participated in our recruiting process, demonstrating their keen interest in and endorsement of our study.
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Is the work clearly and accurately presented and does it cite the current literature?
Yes
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Partly
If applicable, is the statistical analysis and its interpretation appropriate?
I cannot comment. A qualified statistician is required.
Are all the source data underlying the results available to ensure full reproducibility?
No
Are the conclusions drawn adequately supported by the results?
Partly
Competing Interests: No competing interests were disclosed.
Is the work clearly and accurately presented and does it cite the current literature?
Partly
Is the study design appropriate and is the work technically sound?
No
Are sufficient details of methods and analysis provided to allow replication by others?
No
If applicable, is the statistical analysis and its interpretation appropriate?
No
Are all the source data underlying the results available to ensure full reproducibility?
No
Are the conclusions drawn adequately supported by the results?
No
References
1. Koert E, Takefman J, Boivin J: Fertility quality of life tool: update on research and practice considerations.Hum Fertil (Camb). 2021; 24 (4): 236-248 PubMed Abstract | Publisher Full TextCompeting Interests: No competing interests were disclosed.
Reviewer Expertise: IVF
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