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ORIGINAL ARTICLE
Year : 2018  |  Volume : 12  |  Issue : 1  |  Page : 20-28

Prevalence and prognostic factor in patients with good therapeutic response in a cohort of 172 patients with the homoeopathic medicine Aranea diadema: A multicentre, open-label, observational study


1 Central Council for Research in Homoeopathy, New Delhi, India
2 Dr. Anjali Chatterjee Regional Research Institute (Homoeopathy), Under Central Council for Research in Homoeopathy, Kolkata, West Bengal, India
3 Dr. D. P. Rastogi Central Research Institute (Homoeopathy), Under Central Council for Research in Homoeopathy, Noida, India
4 Regional Research Institute for Homoeopathy, Shimla, Himachal Pradesh, India
5 Regional Research Institute for Homoeopathy, Imphal, Manipur, India
6 Retired, Regional Research Institute for Homoeopathy, Gudivada, Andhra Pradesh, India
7 Regional Research Institute for Homoeopathy, Under Central Council for Research in Homoeopathy, Puri, Odisha, India
8 Retired, Homoeopathic Drug Research Institute, Lucknow, Uttar Pradesh, India
9 Homoeopathy University, Jaipur, Rajsthan, India

Date of Web Publication3-Apr-2018

Correspondence Address:
Dr. Jaya Gupta
Central Council for Research in Homoeopathy, New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijrh.ijrh_6_18

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  Abstract 


Aim: To assess the prevalence and prognostic factor of Aranea diadema in a population responding well to Aranea diadema. Material and Methods: It was an open label, multicentric observational study wherein patients having minimum two known symptoms matching with the pathogenesis of Aranea diadema were prescribed the remedy in 6C, 30C, 200C, and 1M potencies. The collected data were presented in terms of descriptive statistics. Results: A total of 6806 cases were enrolled. Out of which a total of 172 cases were analysed, and demographic analysis shows male/female: 109/63; mean age 28.3 years. There were “clinical successes” in 115 cases (67.0%) and no response in 57 (33.1%) cases. The number of symptoms found prevalent in responders included proving (n = 13) and literature (n = 8). Symptoms coming from provings guide homoeopathic practitioners in prescribing their medicines, but should also be confirmed in patients responding well to these medicines. Significantly higher prevalence was observed among responders in respect of six tentatively confirmed symptoms (prevalence): Forgetfulness (0.11), white coated tongue (0.21), epistaxis (0.10), thirstlessness (0.13), seminal emissions (0. 23), and fever (0.12). Conclusion: This study was conducted to assess the prevalence of symptoms in a population responding well to Aranea diadema and to compare this with the prevalence of these symptoms in other populations. If a symptom has a higher prevalence in a population responding well to Aranea it indicates the increase of likelihood of a curative action of Aranea when that symptom is present. Our “test”is not meant to diagnose an illness but to increase the accuracy of prescribing Aranea diadema.

Keywords: Aranea diadema, Cohort, Homoeopathy, Likelihood ratio, Prevalence


How to cite this article:
Gupta J, Manchanda RK, Chakraborty P, Singh P, Ramteke S, Singh O, Prasad V G, Das K C, Pradhan P K, Singh J P, Gupta P, Rakshit G, Kumar A, Pramanik A, Nayak C, Azis SP. Prevalence and prognostic factor in patients with good therapeutic response in a cohort of 172 patients with the homoeopathic medicine Aranea diadema: A multicentre, open-label, observational study. Indian J Res Homoeopathy 2018;12:20-8

How to cite this URL:
Gupta J, Manchanda RK, Chakraborty P, Singh P, Ramteke S, Singh O, Prasad V G, Das K C, Pradhan P K, Singh J P, Gupta P, Rakshit G, Kumar A, Pramanik A, Nayak C, Azis SP. Prevalence and prognostic factor in patients with good therapeutic response in a cohort of 172 patients with the homoeopathic medicine Aranea diadema: A multicentre, open-label, observational study. Indian J Res Homoeopathy [serial online] 2018 [cited 2018 Jun 18];12:20-8. Available from: http://www.ijrh.org/text.asp?2018/12/1/20/229070




  Introduction Top


The papal cross spider from which the Aranea diadema (Aranea diadema) is prepared is generally found in several places in the northern hemisphere. This is usually found inhabiting the stables, old walls, and other such places all over America as well as Europe.[1] Its scientific name is Epeira diadema and the common names are diadem spider,[2],[3] The cross spider,[4] and the papal cross spider,[3],[4],[5] which belongs to the family Araneidae.[4],[5] The diadem spider has got its name from the yellow-and-black cross marks on its back.[1]Araneus diadematus is one of the most common and best-known orb weavers.[6]

The venom of the aranea secreted by a vesicle situated in the chelicerae or in the head and thorax, and which communicates through an excretory duct. A bite from one of the large species, known in South America as spider crabs, can cause death of small vertebrates. It can even bring about an attack of fever in human, although not death.[6] The homoeopathic medicine is prepared from venom of the spider. The remedial properties of this venom were first stated by the von Grauvogyl, during the mid-nineteenth century.[1],[7]

This German homoeopath used Aranea diad e ma for people enduring anomalous feeling too cold and damp, primarily, to treat disorders of the nervous system distinguished by neuralgia with unexpected and aggressive soreness that results in wincing and occurs at regular intervals, for instance facial neuralgia. The symptoms of this condition include acute burning nerve pain that affects the cheek, lips, gums or chin on one side of the face. Numbness and a sensation of heaviness are other symptoms of neuralgia.[1] The amino acid composition of the spider silk is a highly unusual protein. Amino acids with short side chains make up 50%–60% of the total fibroin (Foelix 1982).[6]

These constitutions are favourable to malarial poisoning, where every damp day or place favours chilliness and the patient feels cold in the bones which is not relieved by anything.[5] Sensation as if the bones felt like ice, especially with chronic intermittent fever, when the symptoms are aggravated during every change of weather. There is complaint of chilliness, followed by little or no fever. Chill and neuralgic attacks at the same hour every day, every other day, week, month or regular period were observed.[7]

Restless sleep, waking at night; sensation as if parts (head, face, hands, etc.) were enlarged and heavier, hands feel twice their normal size. Diarrhoea associated with great rumbling in the bowels, as if considerable fermentation were going on within.[8] Numbness of the parts supplied by the ulnar nerve. Especially indicated in disease of os calcis (heel bone), with boring, digging pain.[9] Periodic occurrence of the symptoms at exactly same hour is the important feature of this medicine.[10],[11] All the symptoms of Aranea diadema are characterised by periodicity and coldness and great susceptibility to dampness.[12] Pains like electric currents, Exhaustion; Great desire to lie down; many symptoms ameliorated by lying down.[2] Literature suggests that clinically, it is useful for allergies, arthritis, diarrhoea, caries of bone, dysmenorrhoea, dyspepsia, intermittent fever checked by quinine, irregularities of menstruation, scorbutic affections, headaches, haemorrhages, malaria, neuralgia, nephrotic syndrome, obesity, periostitis, punctured wounds, splenomegaly, toothache, etc.[5],[7],[8],[9],[10],[11],[13],[14] Affections of nerves causing neuralgic pains are sudden and violent and appear at the same hour every day.[15]

Regulatory standards and method of preparation of this drug have been mentioned in Homeopathic Pharmacopoeia of India.[2] The first symptomatology goes back to von Grauvogl, who used it on two provers. Thereafter, proving was carried out by Dr Hedwig Kaeske on herself (1955) and verification on four provers by Weckenmann (1959). Madame Eccius Kaeske experimented with it for 4 months during 1955.[6] The drug proving was conducted by the Central Council for Research in Homoeopathy (CCRH) in 1984–1986 using double-blind method. The drug was proved in 6, 30 and 200 centesimal potencies in descending order. The proving was conducted on 16 provers from different social classes. In CCRH drug proving programme, a total of 69 symptoms were identified, as pathogenesis of drug. Out of which, 13 symptoms were found prevalent in this study. Eight symptoms existing in other literature were also found prevalent during this study. Symptoms coming from provings guide homoeopathic practitioners in prescribing their medicines but should also be confirmed in patients responding well to these medicines.


  Materials and Methods Top


Study design and setting

This was a multicentric, prospective, open-label observational study, conducted at eight institutes/units of CCRH located at Vrindavan (Uttar Pradesh), Noida (Uttar Pradesh), Shimla (Himachal Pradesh), Imphal, Gudivada (Andhra Pradesh), Kolkata, (West Bengal), Puri (Odisha) and Lucknow (Uttar Pradesh), from October 2005 to March 2010.

Participants

Patients with acute and chronic complaints from all age groups, both sexes, having minimum two symptoms similar to identified symptoms, were included in the study. Others with regular medication for any systemic diseases, pregnancy and lactation were excluded. After providing patient information sheet in local vernaculars, informed written consent was obtained from the eligible patients or from the guardians in case of minors before participating in the study. Ethical clearance has been taken from Institutional Ethical Committee of the Council.

Study medicine procurement and administration

The study medicine was procured from Good Manufacturing Practice compliant Homoeopathic pharmacy, in various potencies, viz. 6C, 30C and 200C. Initially, the medicine was prescribed in 6C potency three times a day till the improvement or aggravation occurred or for 5–7 days allowing the medicine to act.

Follow-ups

In follow-up visits, the changes in signs and symptoms were noted. If there were any signs of improvement, then placebo was prescribed. If there was status quo, next higher potencies were prescribed in ascending order; 30C twice a day for 3–5 days in acute cases or for 5–7 days in chronic cases; 200C once a week were prescribed and were observed for 2 weeks. 1M potencies were advised once a fortnight followed by 2 weeks' observation.

Keeping in mind the wide variation of presenting complaints, the timeline for follow-up was defined as 2 weeks or oftener as per the protocol. However, as each symptom has its own timeframe for recovery, provision had been kept for adjusting the schedule as per individual need and appropriateness of the cases. Dosage was decided as per the need of the case and in accordance with homoeopathic principles. Any potency could be tried for twice only. If adequate responses were not elicited, the cases were restudied and switched over to the next potency. If no change was observed even after the change of potencies, then the case was closed and considered as a clinical failure or status quo. Such patients were treated in general outpatient department (OPD). If the patient presented with new symptoms of mild intensity, placebo was prescribed and observed further as per guidelines; while the appearance of severe symptoms (new or aggravation of existing symptoms) with sufficient strength to cause considerable discomfort to the patient called for a change of medicine or therapy, and case was considered as 'clinical failure'. Such patients were treated in general OPD.

Outcome

We can compare the prevalence of symptoms in populations responding well to different medicines, but only those medicines whose symptoms were recorded. While calculating the prevalence in the 'whole population', this whole population is different for each symptom because different symptoms were recorded in different population.

Symptoms coming from provings guide homoeopathic practitioners in prescribing medicines but same symptoms should also be confirmed in patients responding well to these medicines. In this programme, symptoms were not systematically recorded if they were not part of the proving symptoms. It is highly unlikely that this symptom was not there in the populations where other medicines were prescribed. This means that we cannot calculate the prevalence of the symptom in the whole population of 6806 patients.

Statistical analysis

The demographic data were presented in descriptive statistics. No standardised questionnaires were adopted to assess the change in symptoms after administration of medicine. However, data were presented using descriptive statistics; absolute values, percentages. The outcomes assessed were as per the observations of the investigators treating the patient, and these are presented in percentages. SPSS version 20 (IBM Corporation) was used for demographic data of the study. For calculating confined LR, MS Excel was used. MedCalc software (MedCalc.com) was used for calculating 95% confidence interval (CI).


  Results Top


Out of 6806 patients visited OPD of investigating centres from October 2005 to March 2010, only 174 patients having symptoms similarity were prescribed Aranea diadema. Out of these, two dropped out and 172 cases were analysed.

The mean age of the patients was 28.3 years (standard deviation = 15.9). Among the enrolled patients, 109 (63.3%) were male and 63 (36.6%) were female. The other sociodemographic features are further detailed in [Table 1]. Symptoms tentatively confirmed are given in [Table 2]. Confined LR values for each symptom have been given in [Table 3].
Table 1: Sociodemographic features of the patients

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Table 2: Prevalence of symptoms in whole population

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Table 3: Prevalence and confined likelihood ratio of tentatively confirmed symptoms of Aranea diadema

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We can compare the prevalence of symptoms in populations responding well to different medicines, but only those medicines whose symptoms were recorded.

The 'confined LR' values in [Table 3] were not real LR values because the denominator (prevalence in the remainder of the population) cannot be calculated. The 'confined LR' values indicate which medicines, out of the medicines with available data, have more than average prevalence of the symptom. The medicines with 'confined LR' values >1, i.e. prevalence above average, could be considered as tentatively confirmed, but these LR values should not be used for entries in respective repertory-rubrics [Figure 1].
Figure 1: Prevalence and confined likelihood ratio of symptoms of Aranea diadema

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Prevalence and confined likelihood ratio of prevalent symptoms

According to the confined LR results, six symptoms could be tentatively confirmed as pertaining to Aranea's symptomatology and to be indications of its employment, because of having a confined LR and a lower end of confined LR's 95% CI >1. Five symptoms had a confined LR ≥1 but with the lower end of the 95% CI below 1 and hence will be classified as probable. Finally, 10 symptoms had a confined LR <1. Suggesting that they should not be considered as pertaining to Aranea diadema, though this should be assessed with caution because in six out of these ten symptoms, the upper limit of the of confined LR's 95% CI was above 1 [Figure 1].


  Discussion Top


A total of six symptoms of Aranea diadema were found more prevalent in comparison with other medicines where the symptoms were recorded.

According to the confined LR results, six symptoms could be tentatively confirmed as pertaining to Aranea's symptomatology and to be indications of its employment, because of having a confined LR and a lower end of confined LR's 95% CI >1. Five symptoms had a confined LR ≥1 but with the lower end of the 95% CI below 1 and hence will be classified as probable. Finally, 10 symptoms had a confined LR <1. Suggesting that they should not be considered as pertaining to Aranea diadema, though this should be assessed with caution because in six out of these ten symptoms, the upper limit of the of confined LR's 95% CI was above 1 [Figure 1].

We cannot recommend mentioning of LR values in respective repertory-rubrics, only mentioning medicines in plain type, because LR values can only be given if we know the prevalence of symptom in the whole population.

The strength of this research was that it compared, contrary to former information about homoeopathic medicines, the prevalence of symptoms between different medicines.

A weakness of this research was that the symptom were not systematically recorded, leaving much uncertainty about the prevalence of symptoms in population where the symptom was not recorded.

In this study, appraisal of causal relationship between improvement and prescribed medicine was not explicitly performed.

The transition from the homoeopathic notion of 'important symptom' to the modern epidemiological idea of LR has great potential. The task is enormous; in return, we get more reliable instruments. Symptoms can be seen as diagnostic instruments and the LR as an indication for optimal use.

The overall results generated were contributed by different study sites, indicating some generalizability of the study findings. However, being an observational trial, this study cannot address the threats to various external and internal validity issues. In a retrospective analysis of this kind, it is quite difficult to assess when a patient has had a positive evolution and it is much more difficult to attribute it to the treatment.[16]

This problem is much larger in acute cases not excluded in this study because spontaneous recovery is hard to discern from medical recovery.

As per the clinical verification protocol, two types of information were gathered, symptoms on which the Aranea diadema was prescribed and all other general symptoms which were present in the patients, whose correlation with the symptoms of responders needs to be probed and prevalence of specific symptoms related to the drug may be derived. General symptoms are common clinical expressions and require to be given appropriate statistical treatment for quantitative analysis, and the rare, uncommon, peculiar symptoms that Hahnemann has already recognised in his aphorism 153 of the Organon of Medicine may remain a valid bank of qualitative data. However, naturally, more peculiar the symptom, lower is the prevalence in the general population and higher is the LR.[16]

Retrospective assessment of prevalence and LR of symptoms in good responders could be a mean for better selection of symptoms for prospective research; however, feasibility of conducting such retrospective analyses was a fine point of contention.

If the LR method is introduced, the repertory will gradually change as more symptoms are assessed. It will also change the use of the repertory: The most important medicines of each symptom rubric can be identified and relied on, even in large rubrics. This is also a good opportunity to correct structural shortcomings of the repertory; for instance, entries should be based on systematic analysis of Materia Medica instead of casual observations.[17]

LR is based on the relation between the prevalence of a symptom in the population responding to a medicine and the prevalence of the same symptom in the rest of the population. Therefore, it does not matter if the medicine is seldom or frequently prescribed. Another advantage of LR is that it gives a better representation of frequently used medicines in large rubrics. In the present repertory, there are many inaccurate entries of 'large remedies' in large rubrics; the prevalence of the symptom is not greater than in the rest of the population (LR = ±1), so the symptom is no indication for that remedy. When prospective studies using the LR method are performed, the repertory will change gradually as more symptoms are investigated and symptom rubrics become better assessed as the research progresses.[18]

We cannot discard all existing information in the repertory, but gradually the information of LR assessment of an increasing number of symptoms should be added. LR assessment is most efficient for symptoms which occur rather frequently and are regarded as keynotes for certain medicines. Larger symptom-rubrics will benefit the most.[19]

LR investigation is most suited for symptoms that are regarded as keynotes for certain medicines with a not too infrequent occurrence in the population, say 2%–15%. This is a relatively small number of the total proportion of symptoms in the repertory. Hence, most rubrics will still be based on the faulty system of occurrence of the symptom in cure or proving. For proper use of the LR-repertory, it seems necessary to introduce estimates of LR in the rubrics that are not yet assessed. These estimations could be based on a combined translation of type and rubric size. Type should be based on Materia Medica, so keynote symptoms should be in bold type.[19] There are some inconsistencies in the repertory. One is the representation of rare remedies. Changing typefaces on the basis of LR could correct this shortcoming.

To estimate the validity of LR values, CIs should be calculated. For these calculations, we confine our outcome to populations where group 'a' (group presenting a good reaction to the medicine and presenting the symptom) is larger than one.

Rare remedies are homoeopathic medicines with little data. If there is little experience with a medicine, its symptoms are not frequently confirmed. This means that there is no emphasis for these symptoms in the repertory, even if the symptoms are characteristic for the remedy.[19] Introducing LR to the repertory will change not only its content but also its use. Because of the altered use we should consider structural updating. Entries of medicines in the repertory must reflect the importance of the symptom in relation to the remedy, not the occurrence of the symptom in provings and casuistry. This new repertory will increase usefulness and reliability, especially of large rubrics. It will enable us to make more reliable predictions about the number of symptoms we need in one case and the curative potential of a medicine.[20]


  Conclusions Top


This study was conducted to assess the prevalence of symptoms in a population responding well to Aranea diadema and to compare this with the prevalence of these symptoms in other populations. If a symptom has a higher prevalence in a population responding well to Aranea diadema, it indicates the increase of likelihood of a curative action of Aranea diadema when that symptom is present. Our 'test' is not meant to diagnose illness but to increase the accuracy of prescribing Aranea diadema.

Acknowledgements

The authors sincerely acknowledge Dr. Alok Kumar, Former Director General, CCRH, Dr. Vikram Singh, Former Deputy Director, CCRH, and Dr. Krishna Singh, Former Assistant Director, CCRH, for their contribution in monitoring of project during the study. We are thankful to Dr. Varanasi Roja, RO, CCRH, HQ, for giving technical inputs for the article. We are thankful to all program officers of the Institutes and units, where project was going on, for their administrative support. We are thankful to Sh. Arvind Kumar, Statistical Assistant, CCRH, for her help in statistical analysis of the study. Last but not least, we are thankful to all the patients for their participation in the study.

Financial support and sponsorship

The study has been funded by Central Council for Research in Homoeopathy, an autonomous organisation under Ministry of AYUSH, Government of India.

Conflicts of interest

None declared.



 
  References Top

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Aranea Diadema. Available from: http://www.herbs2000.com/homeopathy/aranea_diad.htm. [Last accessed on 2016 Dec 16].  Back to cited text no. 1
    
2.
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3.
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Aranea VF. Synoptic Materia Medica. Available from: http://www.homeoresearch.blogspot.in/2011/12/aranea-diadema.html. [Last accessed on 2016 Dec 13].  Back to cited text no. 4
    
5.
Boericke W. Aranea diadema. Boericke's New Manual of Homoeopathic Materia Medica with Repertory. 3rd Revised & Augmented. 9th ed. New Delhi: B. Jain Publishers; 2007. p. 63-4.  Back to cited text no. 5
    
6.
Homeovision.org. Aranea diadema. Available from: http://www.homeovision.org/3576-0-Aranea-diadema.html. [Last accessed on 2016 Nov 10].  Back to cited text no. 6
    
7.
Clarke JH. A Dictionary of Practical Materia Medica. Reprint Edition. New Delhi, India: B. Jain Publishers Pvt., Ltd.; 2004. p. 152-3.  Back to cited text no. 7
    
8.
Varma PN, Vaid I. Encyclopedia of Homeopathic Pharmacopeia. New Delhi: B Jain Publishers (P) Ltd.; 1995. p. 323.  Back to cited text no. 8
    
9.
Farrington EA. Aranea diadema. Clinical Materia Medica. 4th ed. New Delhi, India: B. Jain Publishers Pvt. Ltd.; 1975. p. 80-1.  Back to cited text no. 9
    
10.
Allen TF. Aranea diadema. The Encyclopedia of Pure Materia Medica. 1st Reprint ed., Vol. 7. New Delhi, India: B. Jain Publishers Pvt., Ltd.; 2001. p. 433-5.  Back to cited text no. 10
    
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Allen TF. Handbook of Materia Medica and Homoeopathic Therapeutics. Reprint edition. New Delhi, India: B. Jain Publishers Pvt., Ltd.; 1979. p. 96-7.  Back to cited text no. 11
    
12.
Murphy R. Aranea diadema. Lotus Materia Medica. (Revised). 2nd ed. New Delhi: B. Jain Publishers Pvt., Ltd.; 2009. p. 154-6.  Back to cited text no. 12
    
13.
Cowperthwaite AC. Aranea diadema. Text Book of Materia Medica and Therapeutics. 13th ed. New Delhi, India: B. Jain Publishers Pvt., Ltd.; 2001. p. 74-6.  Back to cited text no. 13
    
14.
Central Council for Research in Homoeopathy. Aranea diadema. Homoeopathic Drug Provings. New Delhi: Central Council for Research in Homoeopathy; 2005. p. 19-22.  Back to cited text no. 14
    
15.
Phatak SR. Materia Medica of Homoeopathic Medicines. Reprint Edition. New Delhi, India: B. Jain Publishers Pvt., Ltd.; 1991. p. 57-8.  Back to cited text no. 15
    
16.
Eizayaga JE, Pozzi MI, Canan MC, Saravia L. Prevalence and likelihood ratio of symptoms in patients with good therapeutic response to Lycopodium clavatum. A retrospective study. Homeopathy 2016;105:78-83.  Back to cited text no. 16
    
17.
Rutten AL, Stolper CF, Lugten RF, Barthels RW. Is assessment of likelihood ratio of homeopathic symptoms possible? A pilot study. Homeopathy 2003;92:213-6.  Back to cited text no. 17
    
18.
Rutten AL, Stolper CF, Lugten RF, Barthels RW. Repertory and likelihood ratio: Time for structural changes. Homeopathy 2004;93:120-4.  Back to cited text no. 18
    
19.
Stolper CF, Rutten AL, Lugten RF, Barthels RJ. Improving homeopathic prescribing by applying epidemiological techniques: The role of likelihood ratio. Homeopathy 2002;91:230-8.  Back to cited text no. 19
    
20.
Rutten AL, Stolper CF, Lugten RF, Barthels RW. Assessing likelihood ratio of clinical symptoms: Handling vagueness. Homeopathy 2003;92:182-6.  Back to cited text no. 20
    


    Figures

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    Tables

  [Table 1], [Table 2], [Table 3]



 

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