Liquidia Corporation Reports Third Quarter 2026 Financial Results
Settlement payments total net $380.7 million in 2026 and 2027, alongside continued YUTREPIA availability without patient discontinuations.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Liquidia (NASDAQ: LQDA) reported third-quarter 2026 YUTREPIA net product sales of $222.7 million, up 31% from the second quarter. Sales compared with $51.7 million a year earlier. Net loss widened to $236.3 million, or $2.64 per share, from $3.5 million, including a $389.7 million litigation settlement charge. Non-GAAP adjusted EBITDA rose for a fifth consecutive quarter to $140.5 million.
The October 13 settlement with United Therapeutics resolved all six pending lawsuits and preserved uninterrupted YUTREPIA availability. Liquidia agreed to net payments of $380.7 million in 2026–2027, submitted a request to remove the pulmonary hypertension associated with interstitial lung disease indication, and stopped promoting that use. Cash was $396.1 million before settlement payments. YUTREPIA received FDA Fast Track designation for systemic sclerosis-associated Raynaud’s phenomenon, and the Phase 2 RE-WARM study enrolled its first patient.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointGlobal settlement resolved all six pending lawsuits, preserving YUTREPIA availability without required patient discontinuations.
- Moderate pointYUTREPIA sales of $222.7 million rose 31% sequentially, versus $51.7 million in third-quarter 2025.
- Moderate pointNon-GAAP adjusted EBITDA reached $140.5 million, its fifth consecutive quarterly increase.
- Moderate pointCash increased to $396.1 million before settlement payments, versus $190.7 million at December 31, 2025.
- Minor pointPaid patient demand reached $212.2 million in third-quarter 2026, excluding voucher and patient access programs.
15 minor points
- Minor pointOctober patient shipments reached their highest monthly level since launch.
- Minor pointReferral-to-start conversion remained above 87% for monthly referrals.
- Minor pointPrescriber base reached 1,300 through October; first-time prescriber additions exceeded September.
- Minor pointRoughly 60% of prescribers treated two or more patients; more than 30% treated at least five.
- Minor pointFDA Fast Track designation granted for YUTREPIA in systemic sclerosis-associated Raynaud’s phenomenon in September 2026.
- Minor point. Forward-looking: it has not happened yet and may not happen.RE-WARM enrolled its first patient; Liquidia anticipates primary completion of the Phase 2 study in 1Q2027.
- Minor point. Forward-looking: it has not happened yet and may not happen.LTI-403 initiated for pulmonary arterial hypertension patients switching from oral selexipag; primary completion anticipated in 2Q2027.
- Minor point. Forward-looking: it has not happened yet and may not happen.SPRINT initiation anticipated in 4Q2026 to evaluate YUTREPIA’s effect on resistance to blood flow through lung vessels.
- Minor point. Forward-looking: it has not happened yet and may not happen.EASY-PAH registry initiation anticipated in 2027 to evaluate YUTREPIA dosing and longer-term clinical outcomes.
- Minor point. Forward-looking: it has not happened yet and may not happen.Re-Spire enrollment continued; Liquidia anticipates enrollment completion in 2028 and primary study completion in 2029.
- Minor point. Forward-looking: it has not happened yet and may not happen.AMPLIFY-PAH enrollment initiation anticipated in 2027, with primary study completion in 2029 for investigational L606.
- Minor point. Forward-looking: it has not happened yet and may not happen.L606 pivotal study preparations advanced for pulmonary hypertension associated with chronic obstructive pulmonary disease; initiation anticipated in second-half 2027.
- Minor pointNet interest expense fell to $2.9 million from $5.3 million in third-quarter 2025.
- Minor pointIncome tax benefit of $30.1 million recognized, versus none in third-quarter 2025.
- Minor pointService revenue costs fell to $0.8 million from $0.9 million in third-quarter 2025.
Negative
- Major point. Forward-looking: it has not happened yet and may not happen.Settlement obligations total net $380.7 million, payable in multiple installments in 2026 and 2027. 8.9% of market cap
- Moderate pointNet loss widened to $236.3 million, or $2.64 per share, versus $3.5 million, or $0.04, a year earlier.
- Moderate pointPH-ILD label removal requested; Liquidia ceased promotion for pulmonary hypertension associated with interstitial lung disease.
- Minor pointProduct sales costs rose to $14.0 million from $2.3 million in third-quarter 2025, primarily on higher volume.
- Minor pointResearch and development expenses rose to $25.3 million from $9.3 million in third-quarter 2025.
4 minor points
- Minor pointSelling, general and administrative expenses rose to $59.0 million from $40.1 million in third-quarter 2025.
- Minor point. Forward-looking: it has not happened yet and may not happen.Service revenue fell to $2.6 million from $2.7 million; October agreement termination ends future service revenue.
- Minor pointStockholders’ deficit reached $25.434 million at September 30, 2026, versus $44.748 million equity at December 31, 2025.
- Minor pointTotal liabilities rose to $708.376 million from $283.186 million at December 31, 2025.
News Explained
At September 30, 2026, Liquidia reported a stockholders’ deficit of $25,434 thousand.
Liquidia’s third-quarter report says its Sandoz promotion agreement was terminated in
At
Details
Market move: LQDA +4.45% vs previous close. Q3 2026 earnings report
On Nov 10, the day this news came out, the latest delayed price for LQDA is 4.45% above the previous close. Our momentum scanner has recorded 3 alerts for this stock so far that day. The latest delayed price is $50.00. Relative volume is very high at 4.3x what this stock usually trades by this time of day.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.
Key Figures
- Net product sales
- $222.7 million
- Third quarter of 2026
- Quarter-over-quarter sales growth
- 31%
- Third quarter of 2026 versus second quarter of 2026
- Paid patient demand
- $212.2 million
- Third quarter of 2026; excludes voucher and patient access programs
- Net settlement payments
- $380.7 million
- Payable in multiple installments in 2026 and 2027
- Net loss
- $236.3 million
- Third quarter of 2026
- Litigation settlement charge
- $389.7 million
- Included in third-quarter 2026 net loss
- Adjusted EBITDA
- $140.5 million
- Third quarter of 2026; fifth consecutive quarter of increases
- Cash and cash equivalents
- $396.1 million
- As of September 30, 2026, before settlement payments; compared with $190.7 million at December 31, 2025
Previous Earnings Reports
-
YUTREPIA sales reached $170.4 million, with adjusted EBITDA at $96.3 million.
-
Product sales reached $129.9 million; adjusted EBITDA was $71.2 million.
-
YUTREPIA launch sales reached $51.7 million, with adjusted EBITDA of $10.1 million.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
prior approval supplement regulatory
fast track designation regulatory
pharmacodynamics medical
pulmonary vascular resistance medical
open-label medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- YUTREPIA® (treprostinil) inhalation powder net product sales of
$222.7 million in the third quarter of 2026, up31% from the second quarter of 2026 - October 2026 total patient shipments reached their highest monthly level since launch
- Resolved all litigation with United Therapeutics through a global settlement, securing continuity of care for all patients treated with YUTREPIA
- Recorded net loss of
$236.3 million reflects a$389.7 million litigation settlement charge - Fifth consecutive quarter of increasing non-GAAP, adjusted EBITDA to
$140.5 million - Increased cash and cash equivalents to
$396.1 million prior to settlement payments - Granted Fast Track designation for YUTREPIA for the treatment of SSc-RP and initiated RE-WARM, a Phase 2 randomized open-label dose-finding study
MORRISVILLE, N.C., Nov. 10, 2026 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company driven by science and compassion to revolutionize care for patients with challenging respiratory and vascular diseases, today reported financial results for the third quarter ended September 30, 2026. The company will also host a webcast at 8:30 a.m. ET on November 10, 2026, to discuss its financial results and provide a corporate update.
Dr. Roger Jeffs, Liquidia’s Chief Executive Officer, said: “Five quarters after launch, YUTREPIA has rapidly established a preferred product profile because physicians value the control and flexibility it gives them over each patient’s therapy. That affinity and broad adoption have proven durable and our business continues to grow in parallel. With the litigation now fully resolved, and YUTREPIA’s commercial availability secure, we can fully focus on cementing the value of YUTREPIA through Phase 4 studies in PAH that will position it as the best-in-class inhaled therapy and first-in-choice prostacyclin. Simultaneously, we will continue to advance a pipeline that builds on our deep understanding of inhaled treprostinil, from L606 in PAH and PH-ILD to new indications where patients have no approved options, such as SSc-RP and PH-COPD. We are confident that YUTREPIA and L606 can meet the needs of many more patients, both today and in the years ahead, as we look to become the leading provider of inhaled prostacyclin care.”
YUTREPIA Commercial Highlights (as of October 31, 2026, unless indicated otherwise)
- Net product sales of
$222.7 million in the third quarter of 2026. $212.2 million in paid patient demand in the third quarter of 2026, excluding voucher and patient access programs, reflecting growing patient demand.- From launch through September 2026, more than
60% of referrals included a PAH diagnosis, rising to more than70% in September. - In October 2026, total patient shipments reached their highest monthly level since launch.
- In October 2026, the daily referral rate was more than
75% of the daily referral rate for the third quarter. - Conversion of monthly referrals to patient starts remained above
87% . - Prescriber base reached 1,300 through October, adding more first-time prescribers in October 2026 than September 2026.
- Roughly
60% of YUTREPIA prescribers have written for two or more patients, and more than30% have written for at least five patients. 77% of YUTREPIA prescribers have written a PAH prescription since launch.
Clinical Pipeline Updates
YUTREPIA
- Initiated LTI-403, an open-label study to evaluate safety and tolerability of YUTREPIA in adults with PAH who switch from oral selexipag; anticipate primary study completion in 2Q2027.
- Advanced SPRINT, an open-label trial to evaluate the hemodynamic response measured by changes in pulmonary vascular resistance (PVR) following 16 weeks of treatment dosed three or four times daily; anticipate initiation in 4Q2026.
- Advanced EASY-PAH, a prospective, observational U.S. registry of YUTREPIA to evaluate dose regimen, including frequency, titration, and longitudinal clinical endpoints; anticipate initiation in 2027.
- Enrolled first patient in RE-WARM, a Phase 2 randomized open-label dose-finding study to evaluate safety, tolerability and pharmacodynamics of YUTREPIA in adults with systemic sclerosis (SSc) experiencing frequent symptomatic Raynaud's phenomenon (RP) attacks; anticipate primary study completion in 1Q2027. In September 2026, FDA granted Fast Track designation to the program, underscoring the significant unmet need and lack of approved treatments.
L606
- Continued enrollment in Re-Spire, a global pivotal placebo-controlled efficacy study to evaluate L606 in adults for the treatment of PH-ILD. Anticipate enrollment to be completed in 2028 and primary study to be completed in 2029.
- Advanced AMPLIFY-PAH, a pivotal study to evaluate the safety and efficacy of L606 in adults with PAH. Anticipate enrollment to be initiated in 2027 and primary study to be completed in 2029.
- Advanced preparations for a pivotal study to evaluate the safety and efficacy of L606 in adults with PH-COPD. Anticipate initiation in the second half of 2027.
Global Settlement with United Therapeutics
On October 13, 2026, Liquidia entered into a global settlement agreement with United Therapeutics Corporation (United Therapeutics), which resolved all six pending lawsuits between the companies. The settlement followed a September 30, 2026 ruling by the U.S. District Court for the District of Delaware that certain claims of U.S. Patent No. 11,826,327, related to the treatment of PH-ILD with inhaled treprostinil, were valid and infringed. Under the settlement, YUTREPIA remains available to patients without disruption, and no patients are required to discontinue. Liquidia agreed not to appeal the ruling, has submitted a Prior Approval Supplement to remove the PH-ILD indication from YUTREPIA’s label, and has ceased promoting YUTREPIA for PH-ILD. The settlement agreement includes mutual releases without admission of liability by either party.
Under the settlement agreement, Liquidia agreed to pay net
Third Quarter 2026 Financial Results
Net loss for the third quarter of 2026 was
Cash and cash equivalents totaled
Product sales, net, were
Service revenue, net and cost of service revenue, were
Cost of product sales was
Research and development expenses were
Selling, general and administrative expenses were
Litigation settlement, net was
Interest expense, net was
Income tax benefit was
Net loss for the three months ended September 30, 2026, was
Webcast Information
Liquidia will host a live webcast at 8:30 a.m. Eastern Time on November 10, 2026, to discuss the third quarter 2026 financial results and corporate update. The webcast will be available on Liquidia’s website at https://liquidia.com/investors/events-and-presentations. A rebroadcast of the event will be available and archived for a period of one year at the same location.
About YUTREPIA® (treprostinil) Inhalation Powder
YUTREPIA is an inhaled dry-powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device. YUTREPIA was designed using Liquidia’s PRINT® technology, which enables the development of drug particles that are precise and uniform in size, shape and composition, and that are engineered for enhanced deposition in the lung following oral inhalation. YUTREPIA is approved and marketed for the treatment of pulmonary arterial hypertension (PAH). YUTREPIA is not approved for the treatment of systemic sclerosis-associated Raynaud’s phenomenon (SSc-RP); it has received Fast Track designation from the FDA for SSc-RP. YUTREPIA was previously referred to as LIQ861 in investigational studies.
About L606 (liposomal treprostinil inhalation suspension)
L606 is an investigational, extended-release formulation of treprostinil administered twice daily with a next-generation nebulizer. The L606 suspension uses a proprietary liposomal formulation to encapsulate treprostinil which can be released slowly at a controlled rate into the lung, enhancing drug exposure over an extended period of time. L606 is currently being evaluated in an open-label study in the United States for treatment of PAH and PH-ILD and is being evaluated in Re-Spire, a global pivotal placebo-controlled efficacy study to evaluate L606 in adults for the treatment of PH-ILD.
About Pulmonary Arterial Hypertension (PAH)
PAH is a rare, chronic, progressive disease caused by hardening and narrowing of the pulmonary arteries that can lead to right heart failure and eventually death. Currently, more than 50,000 estimated patients are diagnosed and treated in the United States. There is currently no cure for PAH, so the goals of existing treatments are to alleviate symptoms, maintain or improve functional class, delay disease progression and improve quality of life.
About Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
PH-ILD includes a diverse collection of up to 150 different pulmonary diseases, including interstitial pulmonary fibrosis, chronic hypersensitivity pneumonitis, connective tissue disease-related ILD, and chronic pulmonary fibrosis with emphysema (CPFE) among others. Any level of PH in ILD patients is associated with poor 3-year survival. A current estimate of PH-ILD prevalence in the United States is greater than 60,000 patients, though actual prevalence in many of these underlying ILD diseases is not yet known due to factors including underdiagnosis and lack of approved treatments until March 2021 when inhaled treprostinil was first approved for this indication.
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company driven by science and compassion to revolutionize care for patients with challenging respiratory and vascular diseases. The company’s current focus spans the development and commercialization of products in pulmonary hypertension and other applications of its proprietary PRINT® Technology. PRINT enabled the creation of YUTREPIA® (treprostinil) inhalation powder, approved for the treatment of pulmonary arterial hypertension (PAH), and in development for Raynaud’s phenomenon secondary to systemic sclerosis (SSc-RP). The company is also developing L606, an investigational extended-release formulation of treprostinil administered twice daily via a next-generation nebulizer to treat PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD). To learn more about Liquidia, please visit www.liquidia.com.
Abbreviations
1. PAH: pulmonary arterial hypertension. 2. PH-ILD: pulmonary hypertension associated with interstitial lung disease. 3. SSc-RP: systemic sclerosis-associated Raynaud’s phenomenon. 4. PH-COPD: pulmonary hypertension associated with chronic obstructive pulmonary disease.
Cautionary Statements Regarding Forward-Looking Statements
This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and financial initiatives, our business strategy and plans and our objectives for future operations, are forward-looking statements.
Forward-looking statements, including statements regarding the settlement agreement and its anticipated benefits; timing and outcome of FDA review of the Prior Approval Supplement to remove the PH-ILD indication from the YUTREPIA label; the impact of ceasing PH-ILD promotion and sales on YUTREPIA revenue; continued availability of YUTREPIA for patients; clinical trials, clinical studies and other clinical work (including the funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes, timing or associated costs); regulatory applications and related submission contents and timelines; our future results of operations, financial position and cash resources; our estimates regarding future expenses, capital requirements and needs for additional financing; potential revenue and profitability of YUTREPIA; and our development plans for L606 and for YUTREPIA in SSc-RP, PH-COPD or other indications, are forward-looking statements. These statements involve significant risks and uncertainties, and actual results could differ materially from those expressed or implied herein. Among other things, the settlement agreement does not extend to indications other than PAH or to new treprostinil-containing products, and United Therapeutics may assert patents against our development programs or future products. Fast Track designation does not guarantee that YUTREPIA will receive FDA approval for the treatment of SSc-RP or that development will proceed on the anticipated timeline. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks discussed in our filings with the SEC, as well as a number of uncertainties and assumptions. Moreover, we operate in a very competitive and rapidly changing environment and our industry has inherent risks. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Nothing in this press release should be regarded as a representation by any person that these goals will be achieved, and we undertake no duty to update our goals or to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
Use of Non-GAAP Financial Information
This press release and the accompanying tables include U.S. Generally Accepted Accounting Principles (GAAP) and non-GAAP financial measures. For a description of such non-GAAP financial measures, including the reasons for using such measures, and reconciliations of such non-GAAP financial measures to the most directly comparable financial measures prepared in accordance with GAAP, please see the section entitled “About Non-GAAP Financial Information” below.
Contact Information
Investors:
Jason Adair
Chief Business Officer
919.328.4350
Jason.adair@liquidia.com
Media:
media@liquidia.com
Liquidia Corporation
Select Consolidated Balance Sheet Data
(in thousands)
| September 30, | December 31, | |||||||
| 2026 | 2025 | |||||||
| Cash and cash equivalents | $ | 396,091 | $ | 190,680 | ||||
| Total assets | $ | 682,942 | $ | 327,934 | ||||
| Total liabilities | $ | 708,376 | $ | 283,186 | ||||
| Accumulated deficit | $ | (735,05705 | ) | $ | (626,313 | ) | ||
| Total stockholders’ (deficit) equity | $ | (25,434 | ) | $ | 44,748 | |||
Liquidia Corporation
Consolidated Statements of Operations and Comprehensive Income (Loss)
(unaudited)
(in thousands, except share and per share amounts)
| Three Months Ended September 30, | ||||||||
| 2026 | 2025 | |||||||
| Revenues: | ||||||||
| Product sales, net | $ | 222,744 | $ | 51,669 | ||||
| Service revenue, net | 2,556 | 2,673 | ||||||
| Total revenue | 225,300 | 54,342 | ||||||
| Costs and expenses: | ||||||||
| Cost of product sales | 13,985 | 2,295 | ||||||
| Cost of service revenue | 792 | 878 | ||||||
| Research and development | 25,269 | 9,346 | ||||||
| Selling, general and administrative | 59,024 | 40,056 | ||||||
| Litigation settlement, net (inclusive of | 389,749 | — | ||||||
| Total costs and expenses | 488,819 | 52,575 | ||||||
| (Loss) income from operations | (263,519 | ) | 1,767 | |||||
| Interest expense, net | (2,880 | ) | (5,300 | ) | ||||
| Loss before income taxes | (266,399 | ) | (3,533 | ) | ||||
| Income tax benefit | (30,071 | ) | — | |||||
| Net loss and comprehensive loss | $ | (236,328 | ) | $ | (3,533 | ) | ||
| Net loss per common share, basic and diluted | $ | (2.64 | ) | $ | (0.04 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 89,521,467 | 86,333,772 | ||||||
About Non-GAAP Financial Information
To supplement our financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), this press release includes certain non-GAAP financial measures, such as Adjusted EBITDA. We believe the use of such non-GAAP financial measures provides investors with additional insight into our operational performance. While we compute non-GAAP financial measures using a consistent method from quarter to quarter and year to year, we may consider whether other significant items that arise in the future should be excluded from our non-GAAP financial measures.
Adjusted EBITDA is a non-GAAP measure that represents net income for the period before the impact of interest income, interest expense, other income and expense, income taxes, depreciation and amortization, and certain items that impact comparison of the performance of our business either period-over-period or with other businesses.
Adjusted EBITDA should not be considered in isolation or as a substitute to net income or any other measure of financial performance calculated and presented in accordance with GAAP. Our calculation of Adjusted EBITDA may not be comparable to similarly titled measures of other companies because other companies may not calculate them in the same manner as we calculate these measures.
For a reconciliation of such non-GAAP financial measures to the most directly comparable financial measures prepared in accordance with GAAP, please see the table titled “Reconciliation of Non-GAAP Financial Information” below.
Liquidia Corporation
Reconciliation of Non-GAAP Financial Information
Reconciliation of Net Loss to Adjusted EBITDA
(unaudited)
(in thousands)
| Three Months Ended | ||||
| September 30, | ||||
| 2026 | ||||
| Net loss | $ | (236,328 | ) | |
| Interest expense, net | 2,880 | |||
| Income tax benefit | (30,071 | ) | ||
| Depreciation and amortization | 545 | |||
| EBITDA | $ | (262,974 | ) | |
| Litigation settlement, net | 389,749 | |||
| Stock-based compensation | 13,678 | |||
| Adjusted EBITDA | $ | 140,453 | ||
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much did Liquidia’s YUTREPIA sales grow in third-quarter 2026?
YUTREPIA net product sales reached $222.7 million, up 31% from second-quarter 2026 and compared with $51.7 million in third-quarter 2025. The year-over-year increase reflected higher sales volume.
How will Liquidia fund its United Therapeutics settlement payments?
Liquidia expects to fund the net $380.7 million in settlement payments from current cash and cash equivalents and ongoing YUTREPIA sales. Payments are due in multiple installments in 2026 and 2027. Cash and cash equivalents totaled $396.1 million at September 30, 2026, before settlement payments.
What is Liquidia’s RE-WARM study testing?
RE-WARM evaluates YUTREPIA’s safety, tolerability and effects in the body in adults with systemic sclerosis experiencing frequent symptomatic Raynaud’s phenomenon attacks. It is a Phase 2 randomized, open-label dose-finding study, meaning treatment is known to participants and investigators while different doses are evaluated.