Statement of Principles concerning mitral valve prolapse (Reasonable Hypothesis) (No. 15 of 2023)

The Statement organises around a small set of legal‑medical concepts that determine eligibility for veteran/military compensation claims involving mitral valve prolapse. Those concepts are (i) the defined clinical meaning of mitral valve prolapse for this SOP, (ii) death from mitral valve prolapse, (iii) the evidentiary threshold expressed as the “reasonable hypothesis”, and (iv) “relevant service” as the linking legal category.

Definition of mitral valve prolapse. Section 7(2)(a) narrows the medical concept to a degenerative, structural disorder confirmed by echocardiographic studies and specifically involving systolic displacement of an abnormally thickened or redundant mitral leaflet into the left atrium. The instrument rejects broader or phenomenological descriptions: it excludes flail leaflets, inherited connective tissue disorders (including Marfan syndrome), isolated mitral regurgitation without echocardiographic evidence of MVP, and rheumatic mitral valve disease (s 7(2)(b)(i)-(iv)). Note 2 to s 7(2) further excludes a displacement or billowing of the anterior mitral leaflet that is identified only in the 4‑chamber apical view; that is, specific imaging views and criteria are relevant to the diagnosis the SOP uses.

Death from mitral valve prolapse. The SOP treats death as within scope if the terminal event was contributed to by MVP (s 7(5)). The Schedule provides what counts as a “terminal event” (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function), which determines how deaths causally connected to MVP are assessed in claims.

Reasonable hypothesis and qualifying factor(s). The RMA states that “sound medical‑scientific evidence” supports that MVP can be related to relevant service (s 8). For an individual claim, the SOP sets a legal threshold: at least one of the listed factors must exist to raise a reasonable hypothesis connecting MVP (or death from it) with service (s 9). For this SOP the only listed factor (s 9(1)) is inability to obtain appropriate clinical management for MVP. Section 10 requires that any such factor be related to the person’s relevant service, and constrains the operation of the factor: it only applies to material contribution or aggravation where the person’s MVP was suffered or contracted before or during (but did not arise out of) the relevant service (s 10(2)).

Relevant service. The SOP applies to claims under specified statutory provisions (s 5) and uses the Schedule definition of “relevant service”, which includes operational, peacekeeping, hazardous and British nuclear test defence service under the VEA, and warlike or non‑warlike service under the MRCA (Schedule 1). The SOP also provides that if a factor in s 9 refers to another injury or disease that is covered by a different SOP, the factors in that other SOP apply in accordance with its terms (s 11). That cross‑reference mechanism can import other SOP criteria where relevant.

ICD‑10‑AM reference. The SOP acknowledges the ICD‑10‑AM coding (I34.1) but makes explicit that the SOP meaning controls the application for claims (s 7(3)-(4)). The Schedule identifies which ICD edition and provenance is referenced.

Procedurally, the RMA is the instrument maker (s 3), and the SOP came into effect 27 March 2023 (s 2). The previous SOP on MVP (No. 43 of 2014) is repealed (s 4). These main concepts together set the medical definition, evidentiary gateway and the service context in which claims will be evaluated.

The instrument’s coverage is explicitly limited to persons making claims where the relevant statutory claim pathways apply. The SOP “applies to a claim to which section 120A of the VEA or section 338 of the MRCA applies” (s 5). It therefore affects claimants (and their representatives) pursuing entitlements under those provisions, including veterans, members of Peacekeeping Forces, and members of the Forces as defined in the applicable Acts. The Schedule’s definition of “relevant service” identifies the categories of service that connect a person’s health condition to the statutory framework: operational service, peacekeeping service, hazardous service, British nuclear test defence service under the VEA, and warlike or non‑warlike service under the MRCA (Schedule 1). Practically, the instrument most directly affects:

• Individuals seeking recognition and entitlements for mitral valve prolapse or death contributed to by MVP in claims under the VEA or MRCA, because the SOP prescribes the medical and causal criteria that decision makers will apply (ss 5, 7, 9).
• Clinicians and medical experts preparing reports for such claims, because the SOP requires echocardiographic confirmation for MVP and excludes certain conditions from the SOP meaning; reports that do not meet the SOP’s diagnostic standard will not, by themselves, satisfy the RMA’s definition of MVP (s 7(2)(a)-(b)).
• Decision makers in the Department processing VEA/MRCA claims, who must apply the SOP as the prescribed Statement of Principles when assessing whether a reasonable hypothesis exists linking MVP to the claimant’s relevant service (s 3, s 9).
• Dependants and estates where death is alleged to have been contributed to by MVP, because the Schedule defines terminal events and the SOP includes death contributed to by MVP within scope (s 7(5); Schedule).

Who is not affected by this SOP is also important: persons with mitral valve disorders outside the SOP definition are excluded for SOP purposes, for example those with flail leaflets, Marfan syndrome, isolated mitral regurgitation without echocardiographic evidence of MVP, or rheumatic mitral valve disease (s 7(2)(b)(i)-(iv)). Similarly, the SOP does not alter the statutory entitlement rules themselves; it provides the RMA’s medical‑scientific basis that decision makers use when applying the VEA and MRCA claim processes (s 3).

The instrument also has an administrative effect on earlier claim streams because it repeals the prior SOP No. 43 of 2014 (s 4), meaning that claims assessed after the commencement date will be judged against this new definition and factors rather than the old instrument. This change can affect ongoing claims or re‑assessments to the extent those processes call for the contemporaneous SOP.

The Statement itself does not create new statutory rights to payment or impose criminal or civil duties; rather, it prescribes the medical and causal criteria that must be applied by claim decision makers when determining whether a “reasonable hypothesis” exists connecting mitral valve prolapse or death from mitral valve prolapse with relevant service under the VEA and MRCA (ss 3, 5, 9). The legal effect is procedural and evidentiary in the compensation decision process.

Rights that are practically affected by the SOP include the claimant’s right to have their medical condition evaluated against these RMA‑determined criteria when making a claim under the statutory provisions cited (s 5). In other words, claimants are entitled to have the RMA’s Statement applied to their case as the RMA’s authoritative medical view on the relationship between MVP and service.

Duties arise for the administrative decision makers and medical assessors who implement the SOP. They must apply the SOP’s defined meaning of MVP when deciding whether the condition exists for claims purposes (s 7(2)-(3)). They must also require at least one of the listed factors to be present to raise a reasonable hypothesis: in this SOP, the claimant must establish that an inability to obtain appropriate clinical management for MVP existed and that it was related to the person’s relevant service (ss 9, 10(1)). Where a factor in s 9 refers to an injury or disease covered by another SOP, the decision maker must apply the other SOP’s factors in accordance with its terms (s 11).

Operational duties for claim preparation and medical evidence are implied by the SOP’s diagnostic requirements. Medical evidence needs to demonstrate echocardiographic confirmation of MVP as defined (s 7(2)(a)): echocardiographic studies are the condition precedent to classifying the disease as MVP for SOP purposes. For death claims, medical or forensic evidence must show that the terminal event listed in the Schedule was contributed to by MVP (s 7(5); Schedule). The SOP’s Schedule defines “terminal event” through a closed list of examples, which structures the evidentiary approach to causation in fatality cases.

There is also an implied duty to assess temporal relationships. Section 10(2) constrains the operation of the inability to obtain appropriate clinical management factor to situations where MVP was suffered or contracted before or during (but did not arise out of) relevant service, and the SOP requires the factor that exists to be related to the person’s relevant service (s 10(1)-(2)). Thus claimants and decision makers must establish and evaluate timing and causal connections between the service and the condition or its aggravation.

Finally, the SOP imposes a duty on decision makers to treat ICD‑10‑AM coding as referential only: although MVP attracts ICD‑10‑AM code I34.1, the SOP’s statutory meaning is the definition in s 7(2) and that definition governs claim assessment (s 7(3)-(4)). Decision makers must therefore prioritise the SOP’s textual definition over an ICD code in determining whether the condition falls within scope.

The Statement of Principles is not a penal instrument and contains no express criminal, civil or administrative penalties. It is a medical‑scientific instrument made under subsection 196B(2) of the VEA that establishes the criteria decision makers must apply when assessing claims under the VEA and MRCA (s 3). Enforcement in the narrow sense therefore occurs through administrative decision processes under the VEA and MRCA: the SOP binds the medical assessment stage of entitlement decisions rather than creating standalone sanctions.

Practically, enforcement is realised through how claims are accepted or rejected. If a claim is judged not to meet the RMA’s criteria , for example, if there is no echocardiographic confirmation of MVP as required by s 7(2)(a), or if none of the factors in s 9 applies , the decision maker may reject the claim under the relevant statutory scheme. Any statutory remedies, appeals or merits review avenues available under the VEA or MRCA would operate from that administrative decision; the SOP itself does not create an appeal route or penalties (s 5). The instrument does not specify procedural mechanisms for dispute resolution; those are contained in the VEA and MRCA (the SOP merely applies to claims under certain sections) and are therefore outside the SOP text (s 5).

The RMA’s view, set out in s 8, is that there is sound medical‑scientific evidence supporting a relationship between MVP and relevant service, which provides the evidentiary basis the administrative decision makers rely upon. The RMA’s role is to state medical principles; compliance by the department and by medical assessors means applying these principles in claims assessments. Failure to apply the SOP or to apply it correctly could be a ground for administrative challenge in the avenues provided by the VEA or MRCA, but the SOP contains none of those procedural provisions itself.

Because the only listed factor is “inability to obtain appropriate clinical management” (s 9(1)), the SOP concentrates the causal gateway in a single factual matter. That concentration has enforcement consequences: decision makers will focus on evidence addressing access to appropriate clinical management (and the temporal relating of that factor to relevant service under s 10), and absence of such evidence can result in non‑acceptance of a service connection. The text provides no specific evidentiary rules as to how “inability to obtain appropriate clinical management” is to be proved, so administrative assessment and discretion will determine how the factor is enforced in practice.

The SOP is expressly designed to operate within the statutory frameworks of the VEA and MRCA. Section 5 specifies that it applies to claims to which section 120A of the VEA or section 338 of the MRCA applies. The instrument therefore functions as a statutory medical aid to decision making under those Acts: it does not itself create entitlements, but supplies the RMA’s medical view to be used in determining whether a claim within those Acts raises a reasonable hypothesis linking MVP or death from MVP to relevant service (s 3, s 5).

Inter‑instrument interaction. The SOP repeals the earlier Statement of Principles concerning mitral valve prolapse No. 43 of 2014 (s 4). That repeal means that when decision makers are applying the VEA or MRCA in relation to MVP after the commencement date (27 March 2023), the new SOP replaces the old criteria and definitions. Section 11 provides an additional cross‑instrument mechanism: if a factor in s 9 refers to an injury or disease covered by a different SOP made under s 196B(2) of the VEA, then the factors in that other SOP apply in accordance with its terms (s 11). This allows factors to be read together across SOPs where the factual issues overlap.

Interaction with diagnostic classification systems. The SOP notes that MVP attracts ICD‑10‑AM code I34.1 but states that, for applying this SOP, its statutory meaning is the textual definition in s 7(2), not the code alone (s 7(3)-(4)). The instrument specifies the edition and effective date of the ICD‑10‑AM it references (Tenth Edition, effective 1 July 2017), which provides a consistent administrative reference point for coding but not for defining the condition for claims purposes (s 7(4)).

Relationship with the VEA and MRCA. Since the SOP is made under subsection 196B(2) of the VEA, its legal effect is to be used by decision makers in applying the VEA and MRCA claim provisions identified in s 5. This places the SOP in a subordinate but binding evidentiary role: the RMA is given statutory authority to form Statements of Principles that the claims system must apply. Which decision makers apply it and the procedural pathways for appeals, merits review, or judicial review are governed by the VEA and MRCA rather than by this SOP itself; the SOP does not amend those Acts, nor does it purport to override or change entitlement thresholds provided by those Acts beyond providing the RMA’s medical test for a reasonable hypothesis linking condition and service.

Temporal effect and transition. The SOP commences on 27 March 2023 (s 2) and repeals the prior SOP (s 4), which implies that claims decided on or after commencement will be subject to the new criteria. The SOP does not specify transitional arrangements; such details, if required, would be governed by the administrative procedures of the department applying the VEA and MRCA. Thus temporal interaction with prior decisions and the potential for re‑assessment under the new SOP depends on the implementing practices under the Acts.

The instrument itself records a small, explicit amendment history limited to its making and the repeal of its predecessor. Key dates and changes in the instrument text are:

• Date of instrument: The document bears the date 27 February 2023 at the head of the instrument, and it states that it commences on 27 March 2023 (ss 1-2). The RMA Seal is attested by the Chairperson (cover pages).
• Authority and Making: The SOP is made under subsection 196B(2) of the Veterans’ Entitlements Act 1986 (s 3). That subsection authorises the Repatriation Medical Authority to determine Statements of Principles. The instrument does not purport to amend primary legislation; it operates as a subordinate instrument under the authority provided by that subsection.
• Repeal of prior SOP: Section 4 expressly repeals the Statement of Principles concerning mitral valve prolapse No. 43 of 2014 (Federal Register of Legislation No. F2014L00471). The repeal is absolute in the text; there are no stated savings or transitional provisions in this instrument itself. The effect is that this SOP replaces SOP No. 43 of 2014 as the RMA’s operative Statement for MVP from its commencement date.
• No other amendments recorded: The instrument contains no schedules or provisions indicating further amendment dates, staged changes, sunset clauses or periodic review obligations. The Schedule attached is a Dictionary that supports the main text but does not record subsequent variation or amendment history.

Because the instrument is short and self‑contained, its amendment history as recorded in the text is limited to the replacement of the 2014 SOP by this No. 15 of 2023 instrument and the commencement date. The instrument does not record any earlier amendments to itself, nor does it attach any savings, transitional or retrospective application provisions; any transitional implementation would therefore need to be handled through administrative practice under the VEA and MRCA, or by subsequent instruments or legislative change (none of which are contained in this instrument).

The Statement of Principles text does not record any litigation history. It makes no reference to court decisions, tribunals or contested litigation that produced or shaped its content. The instrument’s textual material is limited to the RMA’s view that “there is sound medical‑scientific evidence” indicating that MVP and death from MVP can be related to relevant service (s 8), but it does not identify any judicial or tribunal authority.

Consequently, within this instrument there are no named cases, no citations to judicial decisions, and no report of litigation outcomes. If decision makers, claimants or other parties later challenge applications of this SOP in administrative, tribunal or judicial proceedings, any such litigation would be outside the four corners of this instrument and is not recorded here.

Practically, the absence of litigation references in the SOP has three immediate implications for practitioners relying on this instrument alone:

1. The SOP is an administrative medical direction rather than an adjudicative or judicial statement; its authority derives from the RMA’s statutory mandate under subsection 196B(2) of the VEA (s 3), not from judicial interpretation.
2. Any legal challenge to a particular application of the SOP would proceed under the VEA or MRCA administrative and review mechanisms, and any case law that emerges would supplement but is not part of this instrument. The SOP itself contains no procedural or remedial clauses regarding litigation.
3. Where a claim involves interplay with other medical conditions or where the SOP cross‑references other Statements of Principles (s 11), litigated interpretations of those other SOPs or of the application of “reasonable hypothesis” standards in the VEA/MRCA context may become relevant , but again those materials are external to this document.

Because the brief instrument contains no litigation record, readers who require information on contested interpretations or precedent will need to consult VEA/MRCA case law and tribunal decisions outside the SOP document itself.

This SOP contains multiple features that can materially affect how claims are prepared and decided; these are concrete operational “gotchas” for practitioners and claimants to note because the instrument’s textual constraints determine admissibility and causation findings.

1. Narrow, imaging‑dependent definition of MVP. The SOP requires echocardiographic confirmation and describes MVP in terms of systolic displacement of an abnormally thickened or redundant leaflet into the left atrium (s 7(2)(a)). Echocardiographic evidence is therefore a fundamental evidentiary requirement; clinical assertions without echocardiography that meets the SOP criteria will not satisfy the RMA’s definition (s 7(2)(a)). Note 2 further excludes instances where displacement or billowing of the anterior leaflet is identified only in the 4‑chamber apical view, meaning that certain imaging findings are insufficient (s 7(2) Note 2). Practitioners must therefore ensure imaging reports specifically address the SOP’s diagnostic text.

2. Express exclusions. The SOP excludes flail mitral valve leaflet, inherited connective tissue disorders including Marfan syndrome, isolated mitral regurgitation without echocardiographic evidence of MVP, and rheumatic mitral valve disease (s 7(2)(b)(i)-(iv)). If a claimant’s mitral pathology falls within an exclusion, the SOP will not operate to found a reasonable hypothesis for MVP as defined here.

3. ICD code is not determinative. The SOP acknowledges the ICD‑10‑AM code I34.1 but states that the SOP’s substantive meaning is the text in s 7(2), not the code alone (s 7(3)-(4)). Administrative reliance solely on ICD coding without testing the textual diagnostic criteria may lead to incorrect assessments.

4. Single, narrow qualifying factor. Unlike some SOPs that list multiple potential service‑related factors, this instrument lists only one factor that can raise a reasonable hypothesis: inability to obtain appropriate clinical management for MVP (s 9(1)). This concentrates the claimant’s burden of proof on evidence about access to and availability of appropriate clinical management rather than a broader set of causal mechanisms. Where that evidence is thin or ambiguous, the claim risks failing at the “reasonable hypothesis” gateway.

5. Temporal and causal constraints on the factor. Section 10(2) restricts the operation of the s 9(1) factor to cases where MVP was suffered or contracted before or during (but did not arise out of) relevant service. Thus, inability to obtain appropriate clinical management cannot be used to establish causation where the MVP arose out of service; it only applies to material contribution or aggravation where MVP pre‑existed or commenced prior to or during service. Claim preparation must therefore establish the timing of onset carefully.

6. “Inability to obtain appropriate clinical management” is undefined. The SOP does not define what counts as “inability”, “appropriate”, or “clinical management”. That textual gap gives decision makers discretion and places evidentiary pressure on claimants to show concrete deprivation of care or lack of access to standards of clinical management. Practitioners should plan for evidence addressing availability, referrals, delays, geographic or deployment constraints, and the adequacy of treatments that were accessible.

7. Death claims require contribution to a terminal event. For fatality claims, the SOP treats death as connected to MVP only where MVP contributed to a terminal event or condition listed in the Schedule (s 7(5); Schedule). The Schedule provides a non‑exhaustive list (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function) that frames causation analysis. Medical and forensic evidence must therefore link MVP to the terminal event, not only show the presence of MVP.

8. Cross‑reference to other SOPs can import additional criteria. If the factor in s 9 refers to an injury or disease covered by another SOP, then that other SOP’s factors apply in accordance with its terms (s 11). Practitioners must identify whether claimed facts intersect with other SOPs (for example, where inability to obtain clinical management is actually due to another recognised injury) and prepare evidence accordingly.

9. Repeal of the 2014 SOP with no transitional text. Section 4 repeals the previous SOP No. 43 of 2014. The current instrument contains no explicit transitional or savings provisions. Decision makers may need to determine how existing claims, ongoing reviews or historical medical evidence shaped under the old SOP are treated; administrative practice will govern, but the instrument itself is silent.

10. Applicability limited to specific claim provisions. The SOP applies only to claims under s 120A VEA or s 338 MRCA (s 5). Claims outside those statutory pathways are not governed by this SOP. Practitioners must ensure the claim is within the statutory scope before relying on this SOP.

Each of these textual features alters what evidence is required, how causation is framed, and where decision‑maker discretion will operate. The practical effect is that claimants must focus on imaging that meets the SOP’s diagnostic language, assemble detailed evidence about access to and adequacy of clinical care during the relevant service period, and be prepared to engage with the interaction between this SOP and any other SOPs that the facts may trigger.

Compliance, in the context of this SOP, means preparing and presenting evidence that satisfies the RMA’s defined medical meaning of mitral valve prolapse and establishing the factual factor(s) required to raise a reasonable hypothesis that MVP or death from MVP is related to relevant service. The SOP prescribes a tight evidentiary framework; practitioners should take the following concrete steps grounded in the instrument text.

1. Confirm applicability of the SOP to the claim. Verify that the claim is one to which section 120A of the VEA or section 338 of the MRCA applies, because the SOP only governs those claim pathways (s 5). Identify the claimant’s category of “relevant service” in the terms used by the Schedule, for example operational or peacekeeping service under the VEA, or warlike/non‑warlike service under the MRCA (Schedule 1). If the claim falls outside these provisions, the SOP will not apply.

2. Establish the SOP’s diagnostic standard with echocardiographic evidence. Because the SOP’s definition of MVP requires echocardiographic confirmation of the specific degenerative structural disorder described, obtain and present complete echocardiography reports and images addressing systolic displacement of an abnormally thickened or redundant mitral leaflet into the left atrium (s 7(2)(a)). Ensure that reports explicitly consider the 4‑chamber apical view limitation noted in the SOP (s 7(2) Note 2). If the echocardiography does not document the SOP’s features, the condition will not meet the RMA definition even if ICD coding suggests MVP (s 7(3)-(4)).

3. Address express exclusions. Review the claimant’s medical history to exclude conditions listed in s 7(2)(b)(i)-(iv). If the mitral pathology is due to a flail leaflet, an inherited connective tissue disorder (for example Marfan syndrome), isolated mitral regurgitation without echocardiographic evidence of MVP, or rheumatic disease, the SOP explicitly excludes those presentations. Where such comorbidities or alternative diagnoses exist, evidence should be marshalled to show whether the clinical picture nevertheless fits the SOP definition or whether a different SOP (or no SOP) is applicable.

4. Prove the qualifying factor: inability to obtain appropriate clinical management. The only factor listed in s 9(1) is inability to obtain appropriate clinical management. Because the SOP does not define that phrase, claimants should gather detailed contemporaneous evidence of the nature and effect of access limitations during the relevant service period: clinical notes, referral attempts, communications documenting delays or denial of care, evidence of service location and available medical resources, evacuation records, or statements from treating clinicians. Evidence should show both that appropriate clinical management was unavailable or inaccessible and that this inability materially contributed to or aggravated the MVP where the MVP was suffered or contracted before or during (but not arising out of) relevant service (s 10(2)).

5. Establish the temporal link to relevant service. Section 10 requires that any factor in s 9 be related to the person’s relevant service (s 10(1)). For the s 9(1) factor specifically, demonstrate that the inability to obtain appropriate clinical management occurred in connection with the relevant service and that the MVP pre‑dated or occurred during service (s 10(2)). Documentation of diagnosis dates, service timelines, postings, deployments, and dates of clinical contacts will be central to this task.

6. For death claims, link MVP to a terminal event. If the claim concerns death, obtain medical and forensic evidence that links the MVP to a terminal event as defined in the Schedule (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function) and demonstrates contribution, not mere coincidence (s 7(5); Schedule). Medical opinions should explicitly address the causal contribution of MVP to the terminal event.

7. Consider other SOPs. If the factual circumstances engage another SOP (for example where the inability to obtain appropriate clinical management is caused by an injury or disease covered under another SOP), identify and apply the factors from that SOP as required by s 11. Obtain the relevant SOP text and evidence aligned with its factors because s 11 imports those factors “in accordance with the terms of that Statement of Principles”.

8. Prepare expert opinion to bridge medical and service facts. Given the SOP’s medical specificity and its emphasis on echocardiographic findings and access to care, obtain targeted expert reports that (a) apply the SOP’s definition to the echocardiographic data, (b) explain the causal relationship between inability to access appropriate care and material contribution or aggravation of MVP, and (c) relate that causal analysis to the timing and circumstances of the relevant service. Because the SOP does not define “appropriate clinical management”, experts should articulate standards of appropriate management for MVP and how the claimant’s access fell short.

9. Be ready for administrative interpretation. The SOP leaves interpretive space (for example, on what constitutes “inability to obtain appropriate clinical management”). Expect administrative decision makers to exercise discretion when applying the SOP. Where possible, produce evidence that limits interpretive ambiguity: contemporaneous records, objective measures of availability, authoritative clinical practice guidance, and precise timelines.

10. Note commencement and repeal dates. The SOP commenced on 27 March 2023 (s 2) and repeals the previous 2014 SOP (s 4). Ensure that claim submissions and evidence are assessed against this SOP when the claim falls within the instrument’s temporal operation; check whether any earlier decisions or evidence were produced under the 2014 SOP and prepare submissions explaining how they align with or differ from the new SOP.

Following these steps aligns claim preparation with the RMA’s textually prescribed requirements. Because the SOP sets a narrow set of definitional and causal gates, successful compliance depends on targeted, documentary evidence showing echocardiographic confirmation, a clear temporal link to relevant service, and detailed proof of the inability to obtain appropriate clinical management during the relevant period.