Audit: QRS - PDE5 Inhibitors & Statins to Treat Cancer

Audit conducted on 05/08/2026 19:13 using AI4L / Opus 5

Iterations

Summary

Items Count
Total 91
Passed 81
Failed 0
N/A 10
Pass Rate 100.00%
  • Total = Passed + Failed + N/A
  • Pass Rate = Passed / (Passed + Failed) × 100
  • N/A items are excluded from the pass rate calculation

1. General Rules

# Description Result Comments
1.1 Every claim, magnitude, label, recommendation, and statement in the QRS is literally supported by content in the source ER. 🟢 Spot-checked every populated span against the ER: protocol doses (ER 439/441/443), time-to-effect (ER 490), benefit and risk tiers (ER 163–357), contraindications (ER 379–405), 11 monitoring markers and 6 qualitative markers (ER 518–544).
1.2 Where the ER uses cautious phrasing (“not formally studied”, “None documented in human trials to date”, “theoretical concern”, “data are limited”), the QRS uses the same phrasing. 🟢 “No established timeline” and “benefit against cancer is unproven” mirror the ER’s own hedging (ER 490, 578).
1.3 The QRS never strengthens an ER claim (e.g., “not formally studied” → “not required”) or softens one (e.g., “do not use during pregnancy” → “use with caution during pregnancy”). 🟢 Absolute contraindications remain in the stop gate; “monitor”/”caution” items remain in the interactions gate.
1.4 The QRS does not relabel an ER fact under a different decision category. A “Benefit-Modifying Factor” from ER section is not surfaced as a “Caution”; a “Risk-Modifying Factor” is not surfaced as a “Side Effect”; etc. 🟢 Both gates draw exclusively from ER Key Interactions & Contraindications; benefits and risks draw from their own ER sections.
1.5 PubMed IDs, study citations, expert names, clinical trial identifiers (NCT*), and brand names appear in the QRS only if they appear in the source ER for the same fact. 🟢 No PMIDs, NCT IDs, author names or brand names anywhere in the QRS.
1.6 The QRS does not introduce new attributions. 🟢 No attributions of any kind are present.

2. Focus, Tone & Audience

# Description Result Comments
2.1 The QRS follows the tone of the ER, which is determined by the ER’s own language, phrasing, and framing. 🟢 Matches the ER’s sober “strong idea, no proof” framing.
2.2 The tone of the QRS is simultaneously expert, accessible, objective, and data-driven, but also empowering and encouraging 🟢 Neutral, factual register throughout; risk and benefit given equal weight.
2.3 The QRS reads as a trusted, knowledgeable guide rather than a prescriptive doctor 🟢 Protocol cells are framed as “dosing as used in oncology studies”, not as instructions.
2.4 The QRS avoids language that implies medical or clinical advice 🟢 No imperatives; all cells are descriptive noun phrases.
2.5 The QRS “presents information” instead of “providing guidance”, “recommending”, or “advising” 🟢 No recommending verbs present.
2.6 The QRS never addresses “the reader” directly — it presents evidence, not guidance 🟢 No second-person pronouns anywhere.
2.7 The QRS is written in plain language, avoiding unnecessary medical jargon 🟢 Technical terms retained are ER-verbatim headings and marker names required by items 4.2/4.3.
2.8 Information is presented in a concise and very compact manner 🟢 All list items are single condensed phrases; no elaborations carried over.
2.9 It DOES NOT address the reader directly 🟢 Confirmed; impersonal throughout.
2.10 The target audience is health- and longevity-oriented adults who are risk-aware, proactive, and actively seeking to optimize health or apply the intervention under review. 🟢 Monitoring targets are functional ranges, not conventional lab cutoffs, matching the ER’s audience framing.
2.11 The target audience is willing to employ lifestyle and behavioral changes as well as follow protocols that may be inconvenient, costly, or require effort. 🟢 Full 11-marker panel and a front-loaded cadence are presented without simplification.
2.12 The document is NOT written for the general population, who are unwilling to employ lifestyle and behavioral changes or follow protocols that may be inconvenient, costly, or require effort. 🟢 Content assumes an off-label, physician-supervised repurposing context.
2.13 Framing, takeaways, and risk/benefit weighting throughout the document reflect this audience, including where an intervention’s signal for the average person differs from its signal for this audience. 🟢 The unrelated-to-tumor benefits are separated from the unproven anti-tumor rationale, as in the ER.
2.14 The document’s own voice frames usage in longevity terms, not “anti-aging” (e.g., “anti-aging clinics”, “anti-aging community”, “anti-aging medicine”). Proper names that contain “anti-aging” (e.g., “American Academy of Anti-Aging Medicine”) are quoted verbatim. 🟢 The string “anti-aging” does not occur.
2.15 The document’s own voice uses formal clinical and scientific terminology, not colloquial or consumer-grade language (e.g., “oral medication” not “pill(s)”; “injection” not “shot”; “adverse event” not “bad reaction”). Direct quotes from sources are exempt. 🟢 Clinical register maintained; the plain wording in At-A-Glance is required by item 7.4 and mirrors the ER Conclusion.

3. Template Integrity

# Description Result Comments
3.1 The following labels and headings on the QRS are fixed and not modified: Card and section headings: “Protocol”, “Time to effect”, “Benefits”, “Risk & Side Effects”, “Monitoring”, “Qualitative Assessment”; Gate headings: “Contraindications”, “Key Interactions”; Tier labels: “High”, “Medium”, “Low”, “Speculative”; Table column headers in Monitoring: “Marker”, “Target”, “Why” 🟢 All fixed strings verified identical to the template (QRS lines 445, 495, 545, 579, 605, 643, 678, 682–684, 858).
3.2 All “” from the [qrs_template] are present in the the QRS. 🟢 All 38 template variable names present; marker_#_* expanded to 11 numbered rows and qualitative_item_# to 6 numbered items.
3.3 Spans that are not addressed in a checklist item are left unchanged 🟢 A normalized diff against the template shows no change outside the metadata block, the variable spans, and the repeated marker/qualitative rows; the website="…" spans are untouched.

4. Formatting

# Description Result Comments
4.1 When the source ER section is empty, the QRS uses the ER’s own empty-state phrasing verbatim. Typical phrasings are “None documented in human trials to date” and “Not formally studied” N/A No source ER section that feeds the QRS is empty.
4.2 Where the ER presents a bulleted item as “Label: content”, the QRS uses the ER’s bold label verbatim as the cell or row label. 🟢 Protocol labels (“PDE5 inhibitor dosing as used in oncology studies”, “Statin dosing as used in oncology studies”, “Best time of day”) and all six qualitative labels are ER-verbatim.
4.3 Labels are not paraphrased, abbreviated, or invented. 🟢 All 11 monitoring marker names match the ER table verbatim; no label invented where an ER label exists.
4.4 The QRS DOES NOT use emoji indicators (no 🟩, 🟥, 🟨, etc.). Color and emphasis are conveyed through CSS and bold labels. 🟢 Programmatic scan found no emoji code points in the file.
4.5 The QRS is designed to render on one A4 page. Any section that has more content in the ER than fits the per-section budget is condensed by the LLM, not extended onto a second page. 🟢 Every section is condensed to the shortest form the completeness items (8.2, 9.2, 14.2, 15.2) permit; no elaboration, rationale or effect sizes carried over.

5. Metadata

# Description Result Comments
5.1 The metadata is placed inside a single HTML comment that is the first element after “<!doctype html>” and before any other comment, head, or body content. 🟢 Single comment at lines 2–14, immediately after the doctype.
5.2 Inside that HTML comment the YAML block is delimited by a line “—” opening and a line “—” closing. Text before the opening “—” is permitted but is not parsed as YAML. 🟢 Opening --- at line 3, closing --- at line 13.
5.3 The metadata is not visible in any rendered view of the QRS and is not surfaced by any other element on the sheet. 🟢 Enclosed in an HTML comment; no metadata value is repeated in the body.
5.4 All frontmatter values are trimmed: no leading or trailing whitespace, no surrounding quotes unless the value contains a colon, bracket, or leading special character that requires YAML quoting. 🟢 Only duration: "00:04" is quoted, and it contains a colon.
5.5 The filename of the source ER is stated as “er_filename: [er_filename]” 🟢 Line 4 matches the ER’s own filename frontmatter value.
5.6 Version of the QRS.md file used to create the document is stated as “qrs_prompt_version: [Version of QRS.md]” 🟢 26.7.02, matching the QRS.md version badge.
5.7 Creation date and time of the document is stated as “qrs_creation_date: [YYYY-MMDD-HHMM]” (e.g., 2026-0501-1430) 🟢 2026-0805-1828, correct format.
5.8 The nickname of the AI used to create the document is stated as “qrs_creator_ai_nickname: [qrs_creator_ai_nickname]” 🟢 Opus.
5.9 The nickname of the AI is just a single word model name without version, etc. (e.g., Opus, Sonnet, Grok, Gemini, ChatGPT) 🟢 Single word, no version.
5.10 The full name of the AI used to create the document is stated as “qrs_creator_ai_fullname: [qrs_creator_ai_fullname]” 🟢 Opus 5.
5.11 The full name of the AI consists of the [qrs_creator_ai_nickname] and the model version number and no additional qualifier (e.g., Opus 4.6, Sonnet 3.2, Grok 4.5, Gemini 3.1, ChatGPT 5.4) 🟢 Nickname plus version only; no context-window or other qualifier.
5.12 The filename of the document is stated as “qrs_filename: [filename of this document]” 🟢 Matches the file’s actual name on disk.
5.13 All frontmatter values are trimmed: no leading or trailing whitespace, no surrounding quotes unless the value contains a colon, bracket, or leading special character that requires YAML quoting. 🟢 Re-verified; all values clean.

6. Page Title & Header

# Description Result Comments
6.1 [page_title] is set to the [canonical_topic] of the ER frontmatter followed by “ - Quick Reference Sheet” (e.g., “Intervention - Quick Reference Sheet”). The [canonical_topic] is HTML-entity-encoded as needed (e.g., &amp; for &) 🟢 “PDE5 Inhibitors & Statins to Treat Cancer - Quick Reference Sheet” (line 22).
6.2 [header_topic] is set to the [canonical_topic] of the ER frontmatter, with HTML entities encoded as needed (e.g., &amp; for &) 🟢 Line 417, entity-encoded ampersand.
6.3 [header_subline_date] is set to [qrs_creation_date reformatted as MM/DD/YYYY] 🟢 2026-0805-182808/05/2026.
6.4 [header_subline_model] is set to [qrs_creator_ai_fullname] 🟢 Opus 5 (line 425).
6.5 No additional header content appears: no badge, version stamp, AKA / alternate names line, source-AI attribution, audit date, or QRS variant marker. 🟢 Header carries only the title and the template subline.

7. At-A-Glance Section

# Description Result Comments
7.1 [at_a_glance] is dense, execution-oriented summary of the ER Conclusion section 🟢 Condenses all four paragraphs of the ER Conclusion (ER 572–578).
7.2 [at_a_glance] is no longer than 60 words 🟢 56 words (counted programmatically).
7.3 Every fact in [at_a_glance] is supported by a distinct passage in the ER. 🟢 Dual cholesterol blockade (ER 572), no human study of the pair (ER 574), unrelated benefits (ER 576), well-understood safety with unproven benefit (ER 578).
7.4 It DOES NOT use acronyms or technical classifications that require specialist knowledge, uses plain-language terms instead 🟢 “cholesterol drug”, “one first sold for erectile dysfunction”, “tumor cell’s cholesterol supply”; no acronyms.
7.5 It DOES NOT cite specific trials (names, years, sample sizes, p-values) 🟢 No trial reference of any kind.
7.6 It DOES NOT cite effect sizes, relative risks, or statistical results 🟢 No numbers at all.

8. Contraindications

# Description Result Comments
8.1 The section is derived from the ER Key Interactions & Contraindications section 🟢 All 10 items trace to ER 379–405.
8.2 [stop_items] represent the Contraindications from the ER 🟢 Both absolute contraindications (nitrates, riociguat) plus all eight populations from the ER “should avoid” bullet are present.
8.3 Individual [stop_items] are formatted as <li></li> 🟢 Ten <li> elements inside the stop_items span (lines 582–600).
8.4 Items are as concise as possible. No trailing explanations, no elaborations, no mechanistic rationale, no attributions, no citations, no study details. No content after an em-dash, en-dash, or hyphen-dash (e.g., “— dose reduction required”, “— reduced efficacy”) — these trailing clauses are stripped. Just the key fact. 🟢 ER explanatory tails (“the most advanced grade of liver failure”, “in whom further depletion has no rationale”) are stripped; no dash-clauses remain.
8.5 Parenthetical qualifiers from the ER bullet — time windows, severity classes, threshold values, clinical staging — ARE preserved as part of the item, kept as concise as possible (shortened or trimmed where needed to fit the one-page budget, but never dropped entirely). 🟢 “within 90 days”, “within 6 months”, “Class III–IV”, “below 90 mmHg”, “above 170/100 mmHg”, “(Child-Pugh Class C)”, “below 120 mg/dL” all retained.
8.6 When the ER uses ranking notation inside parens (e.g., “>” for severity ordering) that depends on an explanatory phrase to interpret, normalize the items to a plain comma-separated list rather than carrying through the bare symbol. N/A The ER uses no ranking notation inside parentheses.
8.7 If no [stop_items] are present the section is left empty N/A Stop items are present.

9. Key Interactions

# Description Result Comments
9.1 The section is derived from the ER Key Interactions & Contraindications section 🟢 All 11 items trace to ER 383–403.
9.2 [caution_items] represent the Key Interactions from the ER, excluding any that are already listed as Contraindications 🟢 All 11 non-contraindication ER interaction bullets are represented; nitrates and riociguat correctly excluded.
9.3 Individual [caution_items] are formatted as <li></li> 🟢 Eleven <li> elements inside the caution_items span (lines 608–633).
9.4 Items are as concise as possible. No trailing explanations, no elaborations, no mechanistic rationale, no attributions, no citations, no study details. No content after an em-dash, en-dash, or hyphen-dash (e.g., “— dose reduction required”, “— reduced efficacy”) — these trailing clauses are stripped. Just the key fact. 🟢 Mechanistic explanations and mitigation clauses from the ER are all stripped; no dash-clauses remain.
9.5 Parenthetical qualifiers from the ER bullet — example drug lists, time windows, severity classes, threshold values, clinical staging — ARE preserved as part of the item, kept as concise as possible (shortened or trimmed where needed to fit the one-page budget, but never dropped entirely). 🟢 Named-drug parentheticals retained for every item; the combined final item keeps a trimmed but non-empty list for each of its three drug groups.
9.6 When the ER uses ranking notation inside parens (e.g., “>” for severity ordering) that depends on an explanatory phrase to interpret, normalize the items to a plain comma-separated list rather than carrying through the bare symbol. N/A The ER uses no ranking notation inside parentheses.
9.7 If no [caution_items] are present the section is left empty N/A Caution items are present.

10. Protocol

# Description Result Comments
10.1 The section is derived from the ER Protocol section 🟢 All three cells derive from ER Therapeutic Protocol (ER 439, 441, 443).
10.2 The three sets of [action] items cover the three most important actionable implementation aspects from the ER Protocol section 🟢 PDE5 inhibitor dosing, statin dosing, and timing are the three actionable bullets; the remaining ER bullets are framework, half-life and modifier discussion.
10.3 If less that three distinct actionable implementation aspects are mentioned in the ER the unused sets are left empty and made invisible, not filled with placeholder text or empty-state phrasing. N/A Three distinct actionable aspects exist and all three sets are used.
10.4 All used [action_#label], [action#value], [action#_sub] items are filled with meaningful content derived from the ER Protocol section. 🟢 All nine cells populated with ER-sourced content.

11. Time to Effect

# Description Result Comments
11.1 The three sets of [time] items cover the three most important time-to-effect aspects from the ER 🟢 Cardiovascular event reduction, vasodilatory effect and anti-tumor effect are exactly the three intervals given in ER 490.
11.2 The sets are picked and ordered by the magnitude of the related benefit 🟢 Two High-tier benefits first (cardiovascular, erectile/vasodilatory), then the Low/Speculative anti-tumor rationale.
11.3 If less that three distinct time-to-effect aspects are mentioned in the ER the unused sets are left empty and made invisible, not filled with placeholder text or empty-state phrasing. N/A Three distinct aspects exist and all three sets are used.
11.4 All used [time_#label], [time#value], [time#_sub] items are filled with meaningful content derived from the ER. 🟢 All nine cells populated from ER 490.
11.5 If the ER does not provide any information on time to effect, the section is removed completely from the Protocol Panel N/A The ER provides time-to-effect information.

12. Benefits

# Description Result Comments
12.1 The section is derived from the ER Expected Benefits section 🟢 All eleven benefit headings from ER 163–231 are represented in the four tiers.
12.2 Key variables are [benefits_high], [benefits_medium], [benefits_low], [benefits_speculative] 🟢 All four spans present and populated (lines 547–572).
12.3 Items are as concise as possible. No explanations, no elaborations, no effect sizes, no qualifiers, no attributions, no citations, no study details, no mechanistic explanations, etc. Just the key fact. 🟢 Each tier is a semicolon-separated list of condensed ER headings; no magnitudes or “⚠️ Conflicted” markers carried over.
12.4 Parenthetical content — including effect sizes, sample notes, mechanistic hints, and example studies — is stripped, NOT preserved. 🟢 No parentheses appear in any benefits item.
12.5 If no items of a specific sub-section (high, medium, low, speculative) are present the respective is set to “display=none”, not filled with “None documented in human trials to date” or similar empty-state phrasing. N/A All four ER benefit tiers contain items.

13. Risks

# Description Result Comments
13.1 The section is derived from the ER Potential Risks & Side Effects section 🟢 All fifteen risk headings from ER 259–357 are represented in the four tiers.
13.2 Key variables are [risks_high], [risks_medium], [risks_low], [risks_speculative] 🟢 All four spans present and populated (lines 645–672).
13.3 Items are as concise as possible. No explanations, no elaborations, no effect sizes, no qualifiers, no attributions, no citations, no study details, no mechanistic explanations, etc. Just the key fact. 🟢 Items are ER headings condensed to noun phrases; no frequencies or magnitudes carried over.
13.4 Parenthetical content — including frequencies, severity grades, sample notes, mechanistic hints, and example studies — is stripped, NOT preserved. 🟢 No parentheses appear in any risks item.
13.5 If no items of a specific sub-section (high, medium, low, speculative) are present the respective is set to “display=none”, not filled with “None documented in human trials to date” or similar empty-state phrasing. N/A All four ER risk tiers contain items.

14. Monitoring

# Description Result Comments
14.1 The section is derived from the ER Monitoring section 🟢 Table rows map one-to-one onto the ER Monitoring Protocol & Defining Success biomarker table (ER 518–530).
14.2 All measurable/quantifiable biomarkers from the Monitoring section are listed 🟢 All 11 ER biomarkers present, with targets and rationales matching the ER.
14.3 [monitoring_cadence] is populated with the monitoring cadence/frequency derived from the ER Monitoring section. It is not left with placeholder text or empty. 🟢 Baseline, 6–12 week, 6-month, 6–12-month, annual HbA1c and symptom-triggered CK cadence all captured (ER 514–516, 530).

15. Qualitative Assessment

# Description Result Comments
15.1 The section is derived from the ER Monitoring section 🟢 All six items derive from the ER qualitative marker bullets (ER 534–544).
15.2 All subjective/qualitative biomarkers from the Monitoring section are listed 🟢 Muscle symptoms, headache pattern, exercise capacity, sleep quality, vision and hearing, energy and cognitive clarity — six of six, with ER-verbatim bold labels.

Issues 05/08/2026 19:13

Pass rate 100.00%. No issues found.

Issues 05/08/2026 19:04

  1. 2.15 — Colloquial term for erectile dysfunction: [at_a_glance] (QRS line 434-435) describes one partner as “first sold for erectile problems”, a consumer-grade paraphrase of the formal term “erectile dysfunction” that the ER’s own voice uses in its Conclusion (ER line 572).

Fixes 05/08/2026 19:04

  1. 2.15 — Colloquial term for erectile dysfunction: Replaced “first sold for erectile problems” with “first sold for erectile dysfunction” in [at_a_glance], matching the formal term used in the ER’s own voice; the summary remains 56 words.

Issues 05/08/2026 18:52

  1. 4.5 — Sheet exceeds one-page budget: With 8,024 characters of visible text the sheet is the largest of all 632 QRS sheets (published maximum 7,249, median 3,363) and overruns A4; the Qualitative Assessment card (1,002 characters across six near-verbatim ER sentences), the action and time subs, the marker rationales and the monitoring cadence were carried over unabridged instead of being condensed.

Fixes 05/08/2026 18:52

  1. 4.5 — Qualitative Assessment condensed: All six qualitative items were cut back to the observation itself, dropping the trailing ER rationale clauses (e.g. “…is the leading reason to reassess the statin partner”, “…and a reason to switch agent or dosing time”), reducing the card from 1,002 to 659 characters while keeping every ER bold label verbatim.
  2. 4.5 — Monitoring rationales tightened: The eleven “Why” cells were shortened without changing their meaning (e.g. “Determines the safe rosuvastatin dose and flags kidney injury from rhabdomyolysis” → “Sets the safe rosuvastatin dose; flags rhabdomyolysis kidney injury”), and the LDL-C and blood-pressure targets were compressed.
  3. 4.5 — Protocol and time-to-effect subs shortened: The three action subs and the three time subs were reduced to single compact clauses (e.g. “The vasodilatory effect of a PDE5 inhibitor, which is the erectile and pulmonary effect, is immediate.” → “The erectile and pulmonary vasodilatory effect is immediate.”).
  4. 4.5 — Monitoring cadence trimmed: Redundant wording was removed from the cadence line (“Creatine kinase repeated whenever new muscle symptoms appear, regardless of schedule” → “Creatine kinase whenever new muscle symptoms appear”).
  5. 4.5 — Gate items compressed: Contraindications and Key Interactions were tightened without dropping any item or qualifier — the colloquial “poppers” gloss and redundant “Recent”/”a prior episode of” wording were removed, and the antihypertensive, phosphodiesterase-inhibitor and anthracycline example lists were reduced to representative drugs.
  6. 4.5 — Benefit and risk tiers tightened: Repeated “among … users” constructions and duplicated “statin-associated” prefixes were collapsed (e.g. “statin-associated autoimmune myopathy; statin-associated cognitive symptoms” → “statin-associated autoimmune myopathy and cognitive symptoms”), leaving all eleven benefits and sixteen risks represented. Total visible text fell from 8,024 to 7,045 characters, inside the range of published one-page sheets.

Issues 05/08/2026 18:45

  1. 1.4 — Statin dose relabelled from repurposing clinic: The Protocol cell labelled “Statin dosing as used in oncology studies” (QRS lines 465-476) carries the value “Atorvastatin 20–80 mg daily”, which the ER attributes to the Care Oncology Clinic metabolic repurposing protocol, not to the oncology studies bullet, whose content is simvastatin 40 mg (failed) and atorvastatin 40 mg (cardioprotection trial).
  2. 1.3 — Commercial protocol range presented unqualified: The same cell’s sub-text (QRS lines 473-476) calls 20–80 mg “the range used in the best-documented repurposing protocol” while dropping the ER’s explicit qualification that the clinic charges patients directly, has a financial interest in the protocol, and has published only single-arm retrospective data.

Fixes 05/08/2026 18:45

  1. 1.4 / 1.3 — Statin dose restored to oncology-study source: Replaced the Protocol value “Atorvastatin 20–80 mg daily” (the Care Oncology Clinic repurposing range) with “Atorvastatin 40 mg daily”, and changed the sub-text from “The range used in the best-documented repurposing protocol.” to “The dose that succeeded in the cardioprotection trial.”, so the cell now matches the ER bullet whose label it carries.

Issues 05/08/2026 18:38

  1. 1.1 — Erectile benefit timing not supported: [time_2_sub] (lines 519–522) states the vasodilatory effect “carries the erectile benefit after pelvic cancer treatment” and labels it “Immediate”; the ER says only that the vasodilatory effect is immediate and describes the post-pelvic-treatment erectile benefit as men regaining function over a rehabilitation course.
  2. 4.2 / 4.3 — Protocol labels abbreviated: [action_1_label] “PDE5 inhibitor dosing” (line 449) and [action_2_label] “Statin dosing” (line 464) truncate the ER bold labels “PDE5 inhibitor dosing as used in oncology studies:” and “Statin dosing as used in oncology studies:”.

Fixes 05/08/2026 18:38

  1. 1.1 — Erectile benefit timing not supported: [time_2_sub] changed from “The vasodilatory effect of a PDE5 inhibitor, which carries the erectile benefit after pelvic cancer treatment, is immediate.” to “The vasodilatory effect of a PDE5 inhibitor, which is the erectile and pulmonary effect, is immediate.”, matching the ER’s Mechanism of Action and Practical Considerations wording.
  2. 4.2 / 4.3 — Protocol labels abbreviated: [action_1_label] restored to “PDE5 inhibitor dosing as used in oncology studies” and [action_2_label] to “Statin dosing as used in oncology studies”, the ER bold labels verbatim; [action_1_sub] was trimmed to “At or above the top of the licensed erectile dysfunction range…” to remove the resulting duplication.