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In e xceptional circumstances, the on -site assessment may be unannounced. |
7.2.7 Suspension or Revocation of Approval Suspension or Revocation of APMU approval may occur whenever the APMU fails to comply with applicable International Standards and/or TDs, or where such measure is otherwise required in order to protect the interests of the anti -doping community. |
Without limitation, the following nonconformities in the routine operations of an APMU may be considered in support of Suspension: • Failure to com ply with any of the requirements listed in applicable International Standards and/or TDs; • Failure to cooperate with WADA or the relevant Testing Authority in providing documentation; • Noncompliance(s) with the APMU Code of Ethics; • Major changes in key staff without proper and timely notification to WADA ; • Failure to cooperate in any WADA inquiry in relation to the activities of the APMU ; ABP Operating Guidelines – Version 9.0 – July 2023 Page 74/91 • Noncompliance(s) identified from APMU assessment(s); or • Loss of resources jeopardizing the quality and/or viability of the APMU . |
Noncompliance(s) in APMU performance will be assessed by WADA on a case- by-case basis considering the severity and consequences to the anti -doping system. |
Evidence of serious or multiple noncompliance(s) will be reported by WADA to an external assessment panel, who will make a recommendation to WADA regarding the approval status of the APMU and the required corrective actions and associated deadlines. |
WADA reserves the right to provisionally suspend an APMU ’s approval pending a full investigation. |
Such a decision may be taken by the Chair of WADA’s Executive Committe e. The period and terms of Suspension shall be proportionate to the seriousness of the noncompliance(s) and the need to ensure reliable management of Athlete Passports . |
A period of Suspension shall be of a duration to be decided by WADA and up to a maximum of six (6) months, during which time any nonconformity(ies) must be corrected and such correction documented and reported to WADA . |
If the nonconformity(ies) is/are not corrected during the initial Suspension period, the Suspension shall either be further extended or the APMU approval revoked. |
The Suspension period may be extended up to a maximum of an additional six (6) months, based on justifiable delays in implementing the satisfactory corrective actions. |
If the APMU has provided evidence determined to be satisfactory by WADA that the noncompliance(s) are corrected, the APMU ’s approval shall be re -instated. |
If the APMU has not provided evidence determined to be satisfactory by WADA at the end of the extended Suspension period, not to exceed twelve (12) mo nths, the APMU ’s approval shall be revoked. |
During the period of Suspension of the APMU , the management of all Athlete Passports shall be transferred by the Passport Custodian to another WADA -approved APMU after signing an agreement with this other APMU . |
The WADA Executive Committee shall revoke the approval of any APMU if it determines that Revocation is necessary to ensure reliable management of Athlete Passports . |
Revocation may be based on, but not lim ited to, the following noncompliance(s) in the routine operations of an APMU : • Repeated suspensions of WADA APMU approval; • Systematic failure to comply with applicable International Standards and/or TDs; • Failure to correct a lack of compliance with any of t he requirements listed in applicable International Standards and/or TDs during a Suspension period; • A serious or repeated violation of the APMU Code of Ethics; • Repeated and/or continuous failure to cooperate in any WADA inquiry in relation to the activities of the APMU ; • Serious noncompliance(s) identified from APMU assessment(s); or • Loss of resources jeopardizing the quality and/or viability of the APMU . |
ABP Operating Guidelines – Version 9.0 – July 2023 Page 75/91 7.2.8 Appeals WADA ’s decision to suspend or revoke an APMU ’s approval may be appealed in writing by the APMU before CAS within twenty -one (21) days of the date of receipt of notification. |
8.0 Passport Management and Administration The APMU shall manage all Passports under the custody of the Passport Custodian. |
8.1 Passport Review Process The APMU shall carry out the Passport review process as described in Annex C of the ISRM [1]. |
8.1.1 When assessing a newly matched Sample in a Passport : • The APMU shall assess the validity of individual Samples contained within the Passport in ADAMS and address any observed irregularities according to Article 8.2 of this TD by updating the APMU Report ; • The APMU shall review any new Samples within the updated Passport and provide Target Testing, Sample analysis or other recommendations via the APMU Report as required; • Where required for its analysis, the APMU may request further information from the Passport Custodian including, but not limi ted to, circumstances and details of Sample collection, transport, and analysis, redacted Athlete Competition schedule, travel history, Athlete performance, redacted Athlete medical information, information on an Adverse Analytical Finding (AAF) that is po tentially relevant in the context of the Passport , or altitude/whereabouts information which may help them interpret the new Sample; • Where the Passport includes elements justifying a review or upon request by the Passport Custodian, the APMU shall send the Passport for review in ADAMS by an Expert . |
[Comment : One of the benefits of the ABP is the ability to focus resources on atypical results requiring attention. |
As such, it is not mandatory for an APMU to review all newly matched Samples under their responsibility that do not generate a specific notification requiring mandatory follow -up. |
Nevertheless, at the discretion of the Passport Custodian, an APMU may be requested to review normal Passports .] |
8.1.2 When assessing a Passport that generated an ATPF : • All ATPFs shall be reviewed by a Laboratory -based APMU manager; [Comment : ATPFs are generated by the following primary Markers: hemoglobin (HGB) and the OFF-Score for the Hematological Module; the testosterone to epitestosterone ratio (T/E) in urine, and testosterone (T) and/or the testosterone to androstenedione ra tio (T/A4) in blood for the Steroidal Module; and the GH -2000 score for the Endocrine Module.] |
• The APMU shall review any previous APMU Reports associated with the Passport ; ABP Operating Guidelines – Version 9.0 – July 2023 Page 76/91 • The APMU shall assess the validity of individual Samples contained within the Passport in ADAMS, address any irregularities according to Article 8.2 of this TD and update the APMU Report accordingly; • The APMU shall evaluate the need for urgent Target Testing of th e Athlete and communicate Testing recommendations to the Passport Custodian via the APMU Report as required; • The APMU shall assess the need for additional analysis of existing Samples by specific methods ( e.g., Agents Affecting Erythropoiesis, Gas Chromatography / Combustion / Isotope Ratio Mass Spectrometry [GC/C/IRMS], Steroid Esters, hGH Isoform Differential Immunoassay, etc.) |
and communicate these to the Passport Custodian via the APMU Report as required. |
The APMU may also recommend specific Sample(s) to be placed in long- term storage. |
• If an Expert has previously recommended that follow -up Testing include a minimum number of Samples before further review of an Athlete’s Passport data, the APMU may delay sending the Passport for Expert review until the planned number of Samples have been collected and analyzed; • If, after managing the Sample validity, the Passport remains atypical, the APMU shall, without delay, send the Passport for review in ADAMS by an Expert according to Article C.2.2 of the ISRM [1]. |
In the event of an Expert opinion of: o “Likely Doping”: the APMU shall update the APMU Report indicating “Likely Doping”, specifying any detailed analysis or Testing recommendations from the Expert (if provided), and continue the Passport review process according to Article C.3 of the ISRM [1]; o “Suspicious”: the APMU shall update the APMU Report indicating “Suspicious”, highlighting the main atypical features, and outline a Target Testing strategy (if necessary) based on the Expert recomm endations, or recommend further analysis (e.g., GC/C/IRMS); o “Normal”: the APMU shall update the APMU Report indicating “Normal”, summarizing the review by the Expert and outlining any Testing recommendations provided by the Expert ; o “Likely Medical Condition”: the APMU shall update the APMU Report indicating “Likely Medical Condition” with submission to additional Experts if recommended in the Expert evaluation and should inform the Athlete via the Passport Custodian. |
If the first Expert is not a medical doctor, the Passport should be sent to a medical doctor from the Expert panel prior to contacting the Passport Custodian. |
[Comment : the APMU recommendation in ADAMS should mirror the Expert’s opinion(s) and any changes in the status of the APMU recommendation should be based on a change in Expert opinion(s) upon further review of the Passport .] |
ABP Operating Guidelines – Version 9.0 – July 2023 Page 77/91 8.1.3 When assessing a urine Sample that generated an Atypical Passport Finding - Confirmation Procedure Request ( ATPF -CPR; see TD EAAS [3]) for the steroidal Passport : • The APMU shall assess the validity of the Sample generating the Confirmation Procedure (CP) request in ADAMS, address any irregularities according to Article 8.2 of this TD and update the APMU Report accor dingly; • When the ATPF -CPR has been triggered for a Sample where the presence of ethanol or other factors impacting the steroid profile have been reported, the APMU shall evaluate the need to perform CP(s) and update the APMU Report accordingly within seven (7) days. |
Justification not to proceed with CP (s) may include: o the presence of ethanol glucuronide (EtG) in a Sample from an Athlete with previous similar findings in their Passport with negative GC/C/IRMS results (indicating a pattern of alcohol abuse); or o communication of the existence of other AAFs reported for the Sample to the APMU by the Passport Custodian or Testing Authority , as applicable, which would likely lead to a maxim um sanction; or o communication of the existence of a Therapeutic Use Exemption (TUE) for the Athlete to the APMU by the Passport Custodian or Testing Authority, as applicable. |
[Comment: As stated in the TD EAAS, in such cases, the Passport Custodian , or Testing Authority as applicable, shall advise the Laboratory , in writing and within fifteen (15) days following reception of the ATPF -CPR notification, whether or not to proceed with CP(s) of the Sample’s steroid profile.] |
• In cases when an ATPF -CPR is generated for two (2) or more Samples , which are linked to a single Sample Collection Session from the same Athlete , the APMU should advise the Passport Custodian, and Testing Author ity as applicable, to prioritize the confirmation of the Sample with the highest concentration of Markers of the steroid profile. |
In such cases, the Passport Custodian, or Testing Authority as applicable, shall advise the Laboratory , in writing and within fifteen (15) days following reception of the ATPF -CPR notification, whether or not to proceed with CP(s) of the Sample’s steroid profile. |
8.1.4 When assessing a Suspicious Steroid Profile Confirmation Procedure Request (SSP -CPR): The APMU will receive an SSP -CPR notification through ADAMS when there is no existing urine steroidal Passport for the Athlete in ADAMS (i.e. |
this is the first Sample in the Athlete’s steroidal Passport ), and the Sample’s “steroid profile” meets any of the followi ng criteria: a) T/E ratio > 4.0; b) Concentration of T or E (adjusted for the SG) > 200 ng/mL in males or > 50 ng/mL in females; c) Concentration of A or Etio (adjusted for the SG) > 10,000 ng/mL; ABP Operating Guidelines – Version 9.0 – July 2023 Page 78/91 d) Concentration of 5αAdiol (adjusted for the SG) > 250 ng/mL in males or > 150 ng/mL in females. |
Upon receipt of an SSP -CPR notification: • The APMU shall assess the validity of the Sample generating the CP request in ADAMS, address any irregularities according to Article 8.2 of this TD and update the APMU Report accordingly. |
• The APMU shall evaluate the need to perform CP(s) and update the APMU Report accordingly within seven (7) days of receipt of the SSP -CPR notification. |
T he Passport Custodian, or Testing Authority as applicable, shall advise the Laboratory , in writing and within fifteen (15) days following reception of the SSP -CPR notification , whether the Laboratory shall proceed with CP (s). |
[Comment : In the absence of an ATPF -CPR or SSP- CPR, the APMU may also make a recommendation for CP s of the steroid profile, based on assessment by the APMU .] |
8.1.5 Expert Review of Normal Passports The APMU should provide the Experts from time to time with Passports for review, even when the values are within normal ranges and presenting no suspicious elements, as this will ensure that Experts are provided a balanced perspective on the Athletes’ Passports . |
8.2 Management of Sample Validity 8.2.1 The APMU shall assess and manage the validity of urine, blood (serum) and blood ABP (whole blood) Samples in ADAMS according to applicable International Standards and TD s, including the ISRM [1], TD EAAS [3] International Standard for Laboratories (ISL) [4], and t he International Standard for Testing and Investigations (ISTI) [5]. |
8.2.2 Any changes in Sample validity made by the APMU shall be noted in applicable fields in ADAMS and in the APMU Report . |
8.2.3 Where multiple Samples were provided by an Athlete during a single Sam ple Collection Session and are present in a Passport , the APMU shall invalidate all but one Sample based on assessment by the APMU . |
8.2.4 Where multiple Samples were provided by an Athlete on the same day from different Sample Collection Sessions and are present in a Passport , the APMU may invalidate all but one Sample after assessment by the APMU in consultation with the Passport Custodian, as required 8.2.5 For urine Samples where a substance(s) that may alter the steroid profile is detected by the Laboratory (e.g., alcohol), the APMU may invalidate the Sample when it is considered to affect the sensitivity of the Adaptive Model to detect changes in future Samples . |
ABP Operating Guidelines – Version 9.0 – July 2023 Page 79/91 8.2.6 For blood ABP Samples of suspicious profiles where the Blood Stability Score (BSS) could not be calculated, the APMU shall assess the collection- to-analysis time (CAT), any available temperature logger data, and the potential degradation of blood Markers , including scattergrams, in order to evaluate Sample validity, liaising with (an) Expert (s) as required. |
8.3 The APMU Report The APMU Report is a central element in the administrative sequence of the ABP that shall be entered and maintained by the APMU in ADAMS. |
The APMU Report provides an up- to-date overview of the current status of an Athlete’s Passport together with recommendations, as appropriate, for efficient follow -up by the Passport Custodian. |
The APMU Report serves to update the Passport Custodian, WADA and other ADOs with whom the Passport is shared . |
In addition, it provides a record of events associated with a Passport in ADAMS. |
The APMU Report may include, without limitations: • Assessments of Sample validity by the APMU and/or Experts ; • Recommendations for complementary Analytical Testing (e.g., Agents Affecting Erythropoiesis, HIF stabilizers, Homologous Blood Transfusion, confirmation of steroid profile, GC/C/IRMS, long -term steroid Metabolites , IGF -I analogs, Steroid Esters, hGH Isofor m Differential Immunoassay etc.) |
on Samples collected; • Recommendations for further Analytical Testing on Samples collected previously; • Recommendations for long- term storage of Samples for Further Analysis ; • Target Testing recommendations based on available data and Experts’ recommendations; and • A summary of any recent Expert reviews. |
8.3.1 APMU Reports shall be written in English and should not contain any information that could identify the Athlete. |
8.3.2 The APMU Report shall not contain any reference to an AAF that may be known to the APMU , with the exception of when the AAF is used by the APMU as a reason not to perform CP (s) following an ATPF -CPR or SSP- CPR for the steroid profile (see Articles 8.1.3 and 8.1.4 of this TD). |
If the APMU assessment leads to an Expert review, the APMU may, however, separately inform the Expert (s) of the existence of the AAF . |
Depending on the result of the Expert review, the APMU shall further inform the Results Management Authority managing the AAF of the result of the Expert review, via the Passport Custodian, if that information is potentially relevant in the context of the Results Management based on the AAF. |
[Comment : While Passport sharing is strongly encouraged to enhance ADO efficiencies and program effectiveness through exchange of information and mutual recognition of program outcomes, this must be carried out within the framework of the ISPPPI [2] and Article 14.1.4 of the Code [6]. |
The information regarding an AAF shall therefore not be recorded in the APMU Report and shall not be disclosed unnecessarily. |
Only those individuals and/or organizations involved in the applicable Results Management process should be privy to this in formation.] |
8.3.3 Target Testing recommendations shall be included in the APMU Report with a sufficient level of detail for the Passport Custodian to conduct effective, timely and appropriate Testing. |
ABP Operating Guidelines – Version 9.0 – July 2023 Page 80/91 8.4 Investigating Urine Exchange When a urine Sample steroid profile is not consistent with other Sample (s) from the Athlete’s Passport , urine exchange with the urine of another individual may be suspected and confirmed using DNA analysis across multiple Samples . |
This process is managed a nd reported according to the following steps: • When evaluating a newly matched urine Sample, where other Samples exist in the Athlete’s Passport , the APMU shall evaluate the likelihood that all Samples are from the same individual. |
If a Sample shows inconsistency compared to others in the Passpor t (e.g. |
differences in Marker levels), the APMU shall update the APMU Report indicating “Suspicion of Urine Exchange”; • If the APMU suspects urine exchange, an investigation shall be launched by the Passport Custodian, with support from the APMU , using a combination of actions such as Sample storage, confirmation of the steroid profiles of relevant Samples , collection of additional Samples , and/or DNA analysis, as applicable. |
8.4.1 The outcomes of this investigation may indicate: a) Confirmation by DNA analysis that all Samples belong to the same Athlete. |
In this case, the APMU shall update the APMU Report accordingly. |
b) Multiple DNA profiles ar e present: where at least two (2) different DNA profiles are identified across different Samples , where each urine Sample corresponds to a single DNA profile, however the DNA profile corresponding to the Athlete under investigation is not known. |
A strategy shall be undertaken in order to obtain additional Samples and the APMU shall update the APMU Report accordingly indicating “Multiple DNA Profiles Identified”. |
c) Confirmed urine exchange: where at least two (2) different DNA profiles have been identified, where each urine Sample corresponds to a single DNA profile, and the DNA profile belonging to the Athlete is confirmed with a reasonable degree of certainty ( e.g. |
using multiple Samples , different Sample types, different Sample Collection Personnel ). |
In such cases, the APMU shall update the APMU Report , indicating “Urine Exchange Confirmed”. |
d) Mixed Samples : where multiple DNA profiles are found within individual Samples . |
In such cases, the APMU shall liaise with the Passport Cus todian , or Testing Authority as applicable, regarding the Sample in question to explore whether the Laboratory should consider further investigations towards declaring an AAF for Sample Tampering or Attempted Tampering. |
[Comment: Where Tampering or Attempted Tampering of a Sample can be established by the analyzing Laboratory based on evidence from that Sample alone (e.g., substitution with another fluid, mixing of urines, addition of proteases to the Sample), the Laboratory can report the finding as an AAF or Atypical Finding for Tampering or Attempted Tampering (see Article 4.0 of the TD EAAS [3]). |
In contrast, when urine exchange can be established based on steroid profile and/or DNA evidence across multiple Samples, the APMU shall report the finding of confirmed urine exchange to the Passport Custodian, who shall proceed with Results Management according to Code Article 2.2 [6]] ABP Operating Guidelines – Version 9.0 – July 2023 Page 81/91 8.5 Analysis of Steroid Esters When blood Samples demonstrate atypical or suspicious steroid Markers , or have been collected during the same Sample Collection Session as urine Samples identified with an atypical or suspicious “steroid profile”, the APMU , in consultation with the Passport Custodian, should consider requesting analysis to detect the presence of Steroid Ester(s) in the associated blood Samples . |
The detection of Steroid Ester(s) in blood also constitutes an unequivocal demonstration of the exogenous origin of the steroid(s). |
On the other hand, the absence of detectable Steroid Ester(s) in blood shall not invalidate an AAF based on the GC/C/IRMS analysis in urine. |
8.6 Compiling the ABP Documentation Package 8.6.1 The APMU shall be responsible for compiling the ABP Documentation Package using the template provided by WADA . |
The Passport Custodian shall collect information and bear the cost of compiling ABP Docu mentation Packages unless it has established an agreement to share the costs with relevant Testing Authorities . |
8.6.2 Upon request by the APMU and as needed to compile the ABP Documentation Package , the Passport Custodian shall provide a detailed Athlete Competition and altitude schedule, relevant information from DCFs , temperature logger and Chain of Custody documentation to the APMU . |
8.6.3 The APMU shall confer with the Expert panel to determine the scope of such compilation, including the recommended elements and the number of tests that need to be included. |
It is only mandatory to have a full ABP Laboratory Documentation Package for those Samples that are deemed essential by the Expert panel (see TD LDOC [7]). |
Other relevant Samples , for example those that confirm the baseline levels of a Marker , only require an ABP Laboratory Certificate of Analysis (see TD LDOC [7]). |
If the Passport Custodian is not the Testing Authority of the test requiring Laboratory documentation, the Passport Custodian shall coordinate with the Testing Authority to obtain such documentation. |
[Comment: Where a Laboratory Documentation Package for specific analysis (GC/C/IRMS, ERA or hGH) is requested during the compilation of an ABP Documentation Package, a request should be addressed to the Laboratory as per specific Annex es of the TD LDOC.] |
8.6.4 The following key information shall be included in an ABP Documentation Package regardless of the module (Hematological, Steroidal, or Endocrine): • For the Athlete: age (excluding the date of birth), gender, and sport/discipline; • For all Samples : date and time of collection, ADAMS ordinal number in the Passport , Sample code, Marker values and graphical results obtained by the Adaptive Model ; • For Samples selected by the APMU and Expert panel: o ABP Laboratory Documentation Package(s) and/or ABP Certificate(s) of Analysis from the relevant Laboratory( -ies) and/or ABP Laboratory( -ies) (see TD LDOC [7]); and ABP Operating Guidelines – Version 9.0 – July 2023 Page 82/91 o The Passport Custodian shall provide Chain of Custody documentation, DCF information and a detailed Competition calendar covering the period defined by the selected Samples ; and For the Hematological Module, the following additional information shall be provided for the Samples selected by the APMU and Expert panel: • Temperature profile during the transportation of the blood ABP Sample and, when available, the BSS; and • Responses pr ovided by the Athlete on the ABP Supplementary Report Form during the Sample Collection Session. |
For the Steroidal Module, the following additional information shall be provided for the Samples selected by the APMU and Expert panel: • Urine Samples o pH; o Speci fic gravity (SG); o Laboratory documentation, including screening and confirmed values (where applicable) of steroid concentrations and ratios (see TD LDOC [7] and TD EAAS [3]); o GC/C/IRMS results, where applicable; o Indication of ethanol consumption: urinary concentrations of ethanol and/or ethanol Metabolite(s); o Indication of microbial growth (see TD EAAS [3]); and o Information on the presence or absence of substances that may alter the steroid profile (see TD EAAS [3]). |
• Blood Samples o Laboratory documentation, including screening and confirmed concentrations (where applicable) of steroid Markers (see TD LDOC [7]); For the Endocrine Module, the following additional information shall be provided for the tests selected by the APMU and Expert panel: • Laboratory documentation, including screening and confirmed concentrations (where applicable) of Markers of the Endocrine Module (see TD LDOC [7]); ABP Operating Guidelines – Version 9.0 – July 2023 Page 83/91 9.0 References [1] The World Anti -Doping Code International Standard for Results Management . |
[2] The World Anti -Doping Code International Standard for the Protection of Privacy and Personal Information . |
[3] WADA Technical Document TD EAAS: Measurement and Reporting of Endogenous Anabolic Androgenic Steroid (EAAS) Markers of the Urinary Steroid Profile. |
[4] The World Anti -Doping Code International Standard for Laboratories . |
[5] The World Anti -Doping Code International Standard for Testing and Investigations. |
[6] The World Anti -Doping Code. |
[7] WADA Technical Document TD LDOC: Laboratory Documentation Packages . |
[Comment: Current versions of WADA ISL and Technical Documents may be found at https://www.wada -ama.org/en/anti -doping- partners/laboratories ] ABP Operating Guidelines – Version 9.0 – July 2023 Page 84/91 Part 4: Collaboration Agreement Template A non- mandatory collaboration agreement template is contained herein to facilitate the exchange of relevant information and mutual recognition of ABP program outcomes between ADOs that share Testi ng jurisdiction over a single Athlete (e.g., National Anti -Doping Organization and International Federation). |
Anti-Doping Organizations will need to review and modify this template as necessary to ensure it complies with applicable laws. |
Collaboration Agreement Between [ • ] (hereinafter referred to as “[A]” or as a “Party”) and [ • ] (hereinafter referred to as “[B]” or as a “Party”; and collectively with [A], the “Parties”) WHEREAS the principle of the ABP is to have a single Passport for each Athlete, managed by a single Anti-Doping Organization (ADO) referred to as the Passport Custodian; WHEREAS [A] is an [ADO] that has Testing jurisdiction over certain Athletes and wishes to perform Passport Testing in respect of such Athletes ; WHEREAS [B] is an [ ADO ] that also has Testing jurisdiction over those same Athletes and also wishes to perform Passport Testing in respect of such Athletes ; WHEREAS [A] and [B] wish to establish a framework to govern the exchange of ABP -Related Information (as defined below) and the mutual recognition of Athlete Biological Passport (ABP) program outcomes between [A] and [B] to enhance the efficiency and effectiveness of their respective ABP programs . |
THEREFORE , it is agreed upon between the Parties : ABP Operating Guidelines – Version 9.0 – July 2023 Page 85/91 Clause 1 - Definitions Capitalized and italicized terms used in this Agreement shall have the meanings ascribed to them under the World Anti -Doping Code (“ Code”) whi le capitalized and underlined terms shall have the meanings ascribed thereto in an International Standard, both as amended from time to time. |
[For ease of reference, relevant definitions have been reproduced in Schedule 1 attached hereto.] |
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