Assessment of High-Sensitivity C-Reactive Protein (hs-CRP) Changes Following One Anastomosis Gastric Bypass (OAGB) in Patients with Obesity: A Prospective Cohort Study

doi:10.21203/rs.3.rs-4667357/v1

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Research Article

Assessment of High-Sensitivity C-Reactive Protein (hs-CRP) Changes Following One Anastomosis Gastric Bypass (OAGB) in Patients with Obesity: A Prospective Cohort Study

https://doi.org/10.21203/rs.3.rs-4667357/v1

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Background

Obesity, characterized by excessive adipose tissue, is associated with chronic low-grade inflammation and elevated inflammatory markers such as high-sensitivity C-reactive protein (hs-CRP). This inflammation is linked to obesity-associated medical problems, including cardiovascular diseases. One Anastomosis Gastric Bypass (OAGB) has emerged as an effective metabolic and bariatric surgical procedure to address severe obesity and its associated inflammatory state. This study aims to evaluate the changes in hs-CRP levels following OAGB in patients with obesity.

Methods

In this prospective cohort study, 71 participants with BMI > 35 kg/m², with or without obesity-associated medical problems, underwent OAGB. The hs-CRP levels were measured at baseline, one day, five days, thirty days, and six months post-surgery.

Results

The median baseline hs-CRP level was 8.5 mg/L, initially increasing post-surgery to 19 mg/L, but significantly decreased to 3.5 mg/L at six months (p < 0.001). Significant reductions in weight and BMI were also observed, with median total weight loss (%TWL) of 29% and excess weight loss (%EWL) of 68.2% over six months. Pre-operative hs-CRP levels were the only significant predictor of CRP reduction post-surgery.

Conclusion

OAGB significantly reduces systemic inflammation by decreasing hs-CRP levels, alongside substantial weight loss. These findings support OAGB as a beneficial intervention for mitigating inflammation and improving metabolic conditions in patients with obesity. Further long-term studies are warranted to evaluate the sustained impact of OAGB on inflammatory markers and obesity-associated medical problems.

One Anastomosis gastric bypass

C-reactive protein

high-sensitive C-reactive protein

inflammation

obesity

OAGB significantly reduced hs-CRP levels from a median of 8.5 mg/L pre-operatively to 3.5 mg/L at 6 months post-surgery, indicating a decrease in systemic inflammation.
Substantial weight loss was achieved, with median total weight loss (%TWL) of 29% and excess weight loss (%EWL) of 68.2% over 6 months following OAGB.
Pre-operative hs-CRP levels were the only significant predictor of hs-CRP reduction at 6 months post-surgery, suggesting patients with higher baseline inflammation may benefit more.
No significant correlation was found between weight loss outcomes and hs-CRP reduction, indicating OAGB may reduce inflammation through mechanisms beyond just weight loss.

Obesity has reached epidemic proportions globally, with over one billion people classified as individuals with obesity [1]. It is a significant risk factor for numerous medical problems, including cardiovascular disease (CVD), stroke, type 2 diabetes (T2DM), and cancer [2]. One of the critical mechanisms thought to link obesity to its associated medical problems is chronic low-grade inflammation [3]. Adipose tissue dysfunction in obesity leads to abnormal production of proinflammatory cytokines and reduced secretion of anti-inflammatory factors [4]. This maintains systemic inflammation, which can initiate or exacerbate cardiometabolic disease processes [5]. In a healthy state, anti-inflammatory molecules such as adiponectin predominate suppressing chronic inflammation. However, in obesity, hypertrophic adipocytes and infiltrating proinflammatory macrophages in adipose tissue generate increased levels of cytokines such as TNF-alpha, IL-6, and IL-1beta [6–8]. This dysregulation leads to the dominance of proinflammatory signals over anti-inflammatory signals, creating a state of chronic low-grade inflammation both locally in adipose tissue and systemically throughout the body. The chronic inflammatory response generated by dysfunctional adipose tissue is thought to be involved in the pathogenesis of insulin resistance, atherosclerosis, and other cardiometabolic complications associated with obesity [9].

C-reactive protein (CRP) is a circulating inflammatory marker the liver produces in response to IL-6 and other proinflammatory cytokines. In individuals with obesity, the proinflammatory state created by dysfunctional adipose tissue stimulates increased hepatic synthesis of CRP. Therefore, serum CRP levels are elevated in individuals with obesity and positively correlate with Body Mass Index (BMI) [10]. Elevated CRP levels in obesity signify the presence of systemic inflammation driven by adipose tissue dysfunction. Moreover, prospective epidemiological studies have shown high CRP levels predict the severity of obesity-related medical problems, including liver steatosis [11]. we specifically focused on CRP rather than IL-6 and TNF-α due to its superior reliability and sensitivity as a marker of inflammation, as supported by evidence indicating that CRP, unlike IL-6 and TNF-α, consistently reflects the reduction in systemic inflammation and correlates closely with improvements in metabolic parameters post-surgery [12]. Thus, CRP is a marker of obesity-related inflammation and is associated with the development of obesity complications. Interventions targeting weight loss and inflammation may help reduce circulating CRP [13].

For patients with severe obesity, lifestyle interventions like diet and exercise alone often fail to achieve adequate, sustained weight loss outcomes. Metabolic and Bariatric Surgery (MBS) has become an effective treatment option for weight loss and reducing obesity-related complications and CVD-associated biomarkers when non-surgical approaches are unsuccessful [14, 15]One promising technique is the One-Anastomosis Gastric Bypass (OAGB). Procedures like OAGB may work partly by resolving the chronic inflammatory state associated with obesity. However, only a limited number of studies have examined this issue. Therefore, this prospective cohort study aims to assess the effects of OAGB surgery on high-sensitivity C-Reactive Protein (hs-CRP) levels over six months of follow-up. Demonstrating sustained reduction in CRP could help explain the cardiometabolic benefits observed after MBS and support the role of decreasing chronic inflammation in alleviating obesity-related complications.

Study design

The study was designed as a prospective cohort, following patients throughout six months post-OAGB to assess changes in hs-CRP levels. This study has received approval from the Ethics Committee of the *****. Informed consent was obtained from all participants before enrollment, and the study was conducted according to ethical principles outlined in the Declaration of Helsinki.

Participants

According to the study of Pakiet et al. considering an estimated effect size of 30% for the reduction in CRP levels before and after OAGB, with a margin of error of 5%, 80% power, and a confidence interval (CI) of 95%, and accounting for a 5% dropout rate, the sample size was estimated to be 60 patients [16].

Participants were recruited from the *** [17]. The inclusion criteria were adult patients over 18 years old with a BMI ≥35 kg/m² with or without obesity-associated medical problems, who had not achieved the desired weight loss through lifestyle changes and medical treatment, and who were scheduled for OAGB. Patients were excluded if they had previous MBS, known systematic inflammatory diseases such as autoimmune conditions, active viral or bacterial infections, pregnancy, or taking medications known to affect inflammatory status, such as systemic steroids. Finally, 71 patients were included from September 2022 to September 2023. No patients were lost to follow-up.

Study Setting

Board-certified bariatric surgeons performed all OAGB surgeries at the bariatric surgery center of *****, a high-volume bariatric surgery center with a dedicated multidisciplinary team aligned with the International Federation for the Surgery of Obesity (IFSO) guidelines for metabolic and bariatric surgery [18]. The team includes bariatric physicians, nutritionists, psychiatrists, and nurses who specialize in caring for MBS patients. Standardized surgical protocols were utilized for all participants.

Surgical Technique

OAGB involved creating a 60 -75 cc gastric pouch and 150 -200 cm limb lengths. The anastomosis was made using a 45 mm linear cutter stapler, maintaining a 2 -3 cm diameter. The anastomotic orifices were sutured with 2/0 PDS. All participants underwent the OAGB performed by one surgical team using the mentioned technique. Additional details of the surgical technique were described in our previous publications [19].

Data Collection

Hs-CRP levels in serum were quantified using commercially available high-sensitivity ELISA kits (IBL International, Catalog #EU59151) at designated time points before, one day, five days, 30 days, and six months after OAGB.

Blood samples were collected the day before surgery to establish baseline hs-CRP levels. Trained staff followed standard phlebotomy techniques to obtain blood samples immediately processed for serum isolation via centrifugation. Follow-up blood samples were obtained at the mentioned timeline post-surgery and processed using the same standardized protocols. Serum hs-CRP testing was performed in batches using the ELISA kits according to the manufacturer's instructions.

In addition to hs-CRP testing, demographic information, including age, gender, and body mass index, was extracted from *****. BMI values were also retrieved from the ***** at the follow-up intervals. The same standardized procedures for data collection were followed for all study participants.

Data Analysis

All statistical analyses were conducted using SPSS Statistics software version 27 (IBM Corp; NY, USA). Continuous variables were presented as mean and standard deviation (SD) for normally distributed and median and Interquartile Range (IQR) for non-normally distributed variables. Categorical variables were presented as numbers and percentages. We first assessed the normality of all the constant data using Smirnov-Kolmogorov test. Serum hs-CRP was measured before and after surgery at the designated time points for the primary outcome. Then, we assessed the alternation of serum hs-CRP levels using the Friedman test. The impact of various categorical and continuous variables on post-operative hs-CRP reduction in 6 months was also assessed using a Mann-Whitney U and Kendall’s correlation test, respectively. Finally, using a linear regression model, we predicted hs-CRP reduction in the six months.

Participant Characteristics

We recruited 71 participants for the study. All the participants were successful in completing the follow-up. The median (IQR) age of the participants was 41 (14) years. A total of 62 participants were female, and 9 participants were male. The participants' median (IQR) pre-operative weight and BMI were 117.5 kg (25.6) and 43.43 (7.17) kg/m², respectively. The characteristics of the participants are detailed in Table 1.

Primary outcome: hs-CRP

Serum hs-CRP levels were measured with highly sensitive ELISA kits at the designated time points. (pre-operative, one day, five days, 30 days, and six months after OAGB). The median serum hs-CRP level was 8.5 mg/L before OAGB, initially increased at days one and five after OAGB, then decreased over the six months and reached below the baseline level. The median serum CRP level 6 months after the surgery was 3.50 mg/L. Figure 1 and Table 2 demonstrate the pattern of alterations in serum hs-CRP levels before and following OAGB.

Figure 1 - Mean rank of hs-CRP levels over time

Based on the Friedman test, the mean serum hs-CRP levels differed significantly between the examined time points (Χ²= 97.99; p < 0.001).

Weight Loss outcomes

The weight and BMI of the participants were investigated in the 1^st month and the 6^th month. A significant decrease in weight (χ² = 134.11, p < 0.001) and BMI (χ² = 134.11, p < 0.001) was observed after six months. The median (IQR) of Total Weight Loss (%TWL) and Excess Weight Loss (%EWL) were 29% (6.5) and 68.2% (21.2), respectively. The weight loss outcomes of the participants are outlined in Table 3 and Table 4.

Changes in hs-CRP

The median (IQR) reduction in hs-CRP levels was 2.9 (13.9) mg/L over the six months. We considered the changes in hs-CRP to be the primary dependent variable. Therefore, the effects of various factors, including age, gender, obesity-associated medical problems, weight loss outcomes, and preoperative indices such as BMI, on the extent of CRP reduction over the six months have been measured using statistical analysis methods. In this regard, the impact of the mentioned factors on the 6-month changes in CRP is detailed and observable in Table 5 and Table 6 .

As mentioned in Table 6, the only variable capable of predicting hs-CRP reduction in six months was the pre-operative serum hs-CRP level (Correlation Coefficient= 0.495, p<0.001). Table 7 represents the results of a univariate linear regression model, predicting serum CRP reduction in the six months by the pre-operative serum hs-CRP (adjusted R²=0.24; p<0.01).

In this prospective cohort study, we aimed to assess the changes in hs-CRP levels following OAGB in patients with obesity. Our findings demonstrated a significant reduction in hs-CRP levels from the pre-operative baseline to six months post-surgery. Initially, there was an expected increase in hs-CRP levels immediately post-surgery, likely due to the acute inflammatory response to the surgical intervention. However, this was followed by a significant decrease over the subsequent one and six-month follow-ups, indicating a significant decrease in systemic inflammation. A recent meta-analysis found a significant reduction in several inflammatory markers, including CRP and hs-CRP, after MBS [20]. Although the meta-analysis did not include a subgroup analysis specifically for OAGB regarding CRP changes, previous studies have reported outcomes consistent with our findings, indicating OAGB, like other MBS, can significantly decrease CRP levels and improve metabolic health in patients with obesity [21–24].

The significant reduction in hs-CRP levels in the present study aligns with the understanding that weight loss and improved metabolic profiles post-MBS can alleviate systemic inflammation. MBS has been shown to reduce adipose tissue mass, decrease macrophage infiltration, lower the secretion of pro-inflammatory cytokines, and significantly impact comorbidities associated with chronic inflammation [25]. Conditions such as T2DM, CVD, and metabolic syndrome, which are often exacerbated by inflammatory processes, tend to improve following MBS [25–27]. Furthermore, reducing inflammatory cytokines following MBS is associated with a lower risk of asthma, Alzheimer’s disease, and certain cancers [28].

Although this study aimed to evaluate the short- and mid-term effects of OAGB on hs-CRP levels, several studies have reported sustained long-term improvements in inflammatory markers following MBS. A retrospective cohort study of 163 patients who underwent Roux-en-Y Gastric Bypass (RYGB) or Laparoscopic Sleeve Gastrectomy (LSG) over four years reported significant declines in CRP and hs-CRP levels, correlating with weight loss and T2DM remission. Inflammatory markers followed a U-shaped curve, with the lowest levels at two years post-MBS and a slight, non-significant increase at four years, normalizing in 84% of patients [29]. Another study of 1,180 patients post-RYGB found CRP levels dropped from 1.01 mg/L pre-surgery to 0.18 mg/L at two years, with a slight increase at seven years but remaining below pre-surgery levels. Only 3.2% had elevated CRP at seven years, compared to 32.9% pre-surgery. Factors such as higher pre-surgery CRP, BMI, smoking, and diabetes were linked to less favorable CRP trajectories, indicating the need for ongoing monitoring in these subgroups [30].

Although MBS significantly decreases CRP levels, concerns exist regarding the potential resurgence of inflammatory markers following recurrent weight gain, a common occurrence after MBS. Nevertheless, studies indicate that the anti-inflammatory benefits of MBS, including reduced CRP levels, persist even after recurrent weight gain. Specifically, a study on the metabolic profile of women after RYGB and LSG revealed that despite recurrent weight gain, the biochemical benefits, such as improved insulin sensitivity and lower CRP levels, were maintained compared to preoperative levels [31]. Considering the sustained weight loss and low percentage of recurrent weight gain observed after OAGB [32], it is a promising approach to improving inflammation. Consistently reducing excess body weight can significantly improve inflammatory markers, contributing to better overall health outcomes for patients undergoing this procedure.

In our study, we did not find any significant correlation between age, gender, and obesity-associated medical problems such as dyslipidemia, hypertension, diabetes status, ischemic heart disease, obstructive sleep apnea, and changes in hs-CRP levels following OAGB. Moreover, no significant correlation was found between weight loss outcomes (e.g., preoperative BMI, weight loss, BMI loss, %TWL, %EWL) and changes in hs-CRP. Although there are some discrepancies in the literature on the relationship between weight loss and reduction of hs-CRP and CRP after different bariatric surgery methods other than OAGB [29], our findings align with previous studies showing no significant correlation between weight outcomes and reductions in hs-CRP or CRP after OAGB surgery [22,24]. Furthermore, a recent meta-analysis found no relationship between baseline BMI and changes in CRP levels after MBS. It proposed that alternative mechanisms might contribute to this reduction, such as lower caloric intake, reduced nutrient absorption, or a decreased need for the liver to detoxify ingested substances [33].

Our study highlighted substantial weight loss and reduction in BMI among participants over six months, with a median %TWL of 29% and a median %EWL of 68.2%. The significant weight loss and reduction in BMI achieved through OAGB underscore its efficacy as a metabolic and bariatric procedure. The lack of a linear relationship between baseline BMI and hs-CRP reduction suggests that OAGB can benefit a broad range of patients, regardless of initial BMI. OAGB has shown similar efficacy to RYGB in terms of weight loss and remission of obesity-related medical problems [34], with advantages including shorter operative time, fewer early postoperative complications, and a more straightforward surgical learning curve [35].

Finally, a significant correlation was observed between preoperative hs-CRP levels and hs-CRP reduction following OAGB. Considering the significant correlation between elevated CRP and hs-CRP levels and the risk of coronary artery disease, ischemic stroke, and cardiovascular mortality [36,37], this finding indicates that patients with higher hs-CRP levels stand to benefit more from OAGB. These results underscore the importance of OAGB as a valuable intervention for mitigating obesity-related systemic inflammation and reducing cardiovascular risk. Clinical trials are needed to elucidate if high hs-CRP could be an additional indication for MBS. Moreover, the effect of different MBS surgeries on hs-CRP should be compared to identify which procedures provide the most significant and sustained reduction in inflammatory markers. This comparative analysis could help tailor surgical interventions to individual patient profiles, optimizing outcomes and improving cardiovascular health in patients undergoing MBS.

Strengths and Limitations

This study boasts several strengths, including its prospective cohort design and the comprehensive six-month follow-up, which provides robust data on the short- to mid-term effects of OAGB on both hs-CRP levels and weight loss outcomes. Standardized surgical and post-operative care protocols ensure consistency, reducing potential biases and variability. Despite its strengths, the study has notable limitations. The six-month follow-up period, while valuable, does not capture the long-term sustainability of hs-CRP reduction and weight loss. The lack of a control group limits the ability to directly compare OAGB outcomes with other interventions. Additionally, while efforts were made to standardize protocols and control variables, other unmeasured confounding factors could influence the observed outcomes.

Future Directions

Future research should prioritize extending the follow-up period and comparing different types of MBS to delineate the specific advantages and potential drawbacks of OAGB. Moreover, examining differences within the cohort, particularly between patients who achieve significant weight loss and those who experience insufficient weight loss or recurrent weight gain, will provide valuable insights. Finally, Future research should focus on evaluating the broader implications of inflammatory markers reduction on overall health, CVD risk, and quality of life in the long term.

In conclusion, the study demonstrates a significant decrease in hs-CRP levels six months after OAGB. The only predictor of the hs-CRP reduction was the pre-operative hs-CRP levels. Pre-operative BMI and weight loss outcomes did not significantly correlate with hs-CRP reduction. The findings highlight the potential role of OAGB in resolving the obesity-derived inflammatory state in individuals with obesity.

Conflict of Interest

The authors declare no conflicts of interest related to this manuscript.

Ethical Approval

The Ethics Committee of ***** has registered and approved the study (*****)

Funding Statement

No financial support was received from any resource for this project.

Author Contribution

N.M., A.J., H,M, and P.K. wrote the main manuscript text.A.J. did the statistical analysis of the data.A.J., H.M., and P.K. prepared the tables and figures of the manuscript.N.M., F.H., M.MA., T.T., E.F., and M.M. cooperated in collecting the data including extracting the query from INOSD and following up the individuals in the period of the study.A.H., M.K., and F.E. supervised the project and revised and prepared the final edition of the manuscript.

Data Availability

Data that support the findings of this study is available from the corresponding author upon reasonable request.

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Table 1-Baseline characteristics and obesity-associated medical problems of the participants

Characteristics	Value
Age (years) - Median (IQR)	41 (14)
Female- n (%)	62 (87.4%)
Pre-operative weight (kg) - Median (IQR)	117.5 (25.6)
Pre-operative BMI (kg/m²) - Median (IQR)	43.43 (7.17)
Dyslipidemia - n (%)	12 (16.9%)
Hypertension - n (%)	15 (21.1%)
T2DM - n (%)	5 (7.1%)
IGT - n (%)	5 (7.1%)
Ischemic heart disease - n (%)	2 (2.8%)
Obstructive sleep apnea - n (%)	5 (7.1%)

BMI, Body Mass Index; IQR, Interquartile Range; T2DM, Type 2 Diabetes Mellitus; IGT, Impaired Glucose Tolerance.

Table 2-Friedman test to evaluate the pattern of alterations in serum hs-CRP

Timepoint	Median (IQR) - mg/L	Mean Rank	p-value
Pre-operative	8.5 (11.6)	2.48
Post-operative, day 1	19 (15.4)	3.97
Post-operative, day 5	18.5 (17)	3.96
Post-operative, month 1	13.4 (7.6)	2.68
Post-operative month 6	3.5 (10.4)	1.91	< 0.001*

* Statistically significant

Table 3 - Weight loss outcomes in 6 months

Weight loss outcome	Six months - Median (IQR)
Weight loss - kg	33 (11)
BMI loss - kg/m²	12.7 (3.2)
%TWL	29 (6.5)
%EWL	68.2 (21.2)

BMI, Body Mass Index; %TWL, Total Weight Loss; %EWL, Excess Weight Loss.

Table 4 - Friedman test to evaluate the pattern of alterations in weight and BMI

Timepoint	Median (IQR)	Mean Rank	p-value
Weight - kg
Pre-operative	117.5 (25.6)	2.97
Post-operative, month 1	103.3 (24.3)	2
Post-operative, month 6	83 (17.8)	1.03	<0.001*
BMI - kg/m²
Pre-operative	43.4 (7.1)	2.97
Post-operative, month 1	39.1 (6.7)	2
Post-operative, month 6	31.2 (5.5)	1.03	<0.001*

* Statistically significant

BMI, Body Mass Index.

Table 5 - Mann-Whitney U and Kruskal-Wallis test to investigate the effect of gender and obesity-related medical problems on serum hs-CRP level reduction in 6 months

Groups	Mean Rank	Z score*	H score†	p-value
Gender
Male (n=9)	38.3
Female (n=62)	35.6	-0.36	-	0.717
Dyslipidemia
Yes (n=12)	34.9
No (n= 59)	36.2	-0.19	-	0.848
Hypertension
Yes (n=15)	43.6
No (n=56)	33.9	-1.59	-	0.110
Diabetes status
T2DM (n=5)	32.8
IGT (n=5)	42.1
No DM (n=61)	35.8	-	0.56	0.754
Ischemic heart disease
Yes (n=2)	30.5
No (n=69)	36.2	-0.38	-	0.702
Obstructive sleep apnea
Yes (n=5)	28.3
No(n=66)	36.6	-0.86	-	0.387

*Mann-Whiteny U Z score

†Kruskal-Wallis H score

T2DM: Type 2 Diabetes Mellitus; IGT: Impaired Glucose Intolerance.

Table 6 - Kendall’s correlation test to evaluate the correlation of continuous variables with serum hs-CRP reduction in 6 months

Variable	Correlation Coefficient	P-value
Age	0.006	0.941
Pre-operative BMI	0.086	0.290
Weight loss	0.056	0.493
BMI Loss	0.099	0.220
%TWL	0.069	0.393
%EWL	-0.036	0.659
Serum hs-CRP level
Pre-operative	0.495	< 0.001*
Post-operative, day 1	-0.023	0.777
Post-operative, day 5	0.023	0.777
Post-operative, month 1	-0.109	0.182

* Statistically significant

BMI, Body Mass Index; %TWL, Total Weight Loss; %EWL, Excess Weight Loss.

Table 7- Final model from the univariate linear regression analysis, predicting serum CRP reduction in 6 months

Predictor

p-value

Pre-operative serum hs-CRP

(Adjusted R²=0.24)

1.06

0.22

< 0.001*

* Statistically significant

No competing interests reported.

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You are reading this latest preprint version

Assessment of High-Sensitivity C-Reactive Protein (hs-CRP) Changes Following One Anastomosis Gastric Bypass (OAGB) in Patients with Obesity: A Prospective Cohort Study

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Version 1

Abstract

Background

Methods

Results

Conclusion

Figures

Key points

Introduction

Material and Methods

Study design

Participants

Study Setting

Surgical Technique

Data Collection

Data Analysis

Results

Participant Characteristics

Primary outcome: hs-CRP

Figure 1 - Mean rank of hs-CRP levels over time

Weight Loss outcomes

Changes in hs-CRP

Discussion

Strengths and Limitations

Future Directions

Conclusion

Declarations

Conflict of Interest

Ethical Approval

Funding Statement

Author Contribution

Data Availability

References

Tables

Table 1-Baseline characteristics and obesity-associated medical problems of the participants

Table 2-Friedman test to evaluate the pattern of alterations in serum hs-CRP

Table 3 - Weight loss outcomes in 6 months

Table 4 - Friedman test to evaluate the pattern of alterations in weight and BMI

Table 5 - Mann-Whitney U and Kruskal-Wallis test to investigate the effect of gender and obesity-related medical problems on serum hs-CRP level reduction in 6 months

Table 6 - Kendall’s correlation test to evaluate the correlation of continuous variables with serum hs-CRP reduction in 6 months

Table 7- Final model from the univariate linear regression analysis, predicting serum CRP reduction in 6 months

Additional Declarations

Status:

Version 1