<SEC-DOCUMENT>0001178913-22-001167.txt : 20220317
<SEC-HEADER>0001178913-22-001167.hdr.sgml : 20220317
<ACCEPTANCE-DATETIME>20220317083146
ACCESSION NUMBER:		0001178913-22-001167
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20220317
FILED AS OF DATE:		20220317
DATE AS OF CHANGE:		20220317

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			PAINREFORM LTD.
		CENTRAL INDEX KEY:			0001801834
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-39481
		FILM NUMBER:		22746874

	BUSINESS ADDRESS:	
		STREET 1:		65 YIGAL ALON ST.
		CITY:			TEL AVIV
		STATE:			L3
		ZIP:			6744316
		BUSINESS PHONE:		972-3-7177051

	MAIL ADDRESS:	
		STREET 1:		65 YIGAL ALON ST.
		CITY:			TEL AVIV
		STATE:			L3
		ZIP:			6744316
</SEC-HEADER>
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<TYPE>6-K
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<DESCRIPTION>6-K
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    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">UNITED STATES</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;">SECURITIES AND EXCHANGE COMMISSION</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">Washington, D.C. 20549</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;">Form 6-K</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">Report of Foreign Private Issuer</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">Pursuant to Rule 13a-16 or 15d-16</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">of the Securities Exchange Act of 1934</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">For the month of March 2022</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Commission File Number: 001-39481</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">PainReform Ltd.</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">(Translation of registrant&#8217;s name into English)</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">4 Bruria St. Tel Aviv, 6745442</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Israel</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">(Address of principal executive offices)</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Form 20-F &#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9746;</font> &#160;&#160;&#160;&#160;&#160;Form 40-F &#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9744;</font></div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____</div>
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    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">On March 17, 2022, PainReform Ltd. issued a press release entitled &#8220;PainReform Provides Year-End Business Update; On track to Commence Phase 3 Trial of
      PRF-110 for Non-Opiate Post-Operative Pain Relief in the Second Half of 2022&#8221;. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference. &#160;&#160;</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Exhibit Index</div>
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            <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">Exhibit&#160;No.</div>
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            <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">Description</div>
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            <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
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            <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif;"><a href="exhibit_99-1.htm">99.1</a></div>
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            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
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            <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;"><a href="exhibit_99-1.htm">Press Release dated March 17, 2022.</a></div>
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    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">SIGNATURES</div>
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    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
      undersigned, thereunto duly authorized.</div>
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    <table cellspacing="0" cellpadding="0" style="font-family: Arial; font-size: 10pt; width: 100%; text-align: left; color: #000000;" id="z64098b1a151648058bb3a1094987e263">

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            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Date: March 17, 2022</div>
          </td>
          <td colspan="2" style="width: 32.72%; vertical-align: middle;">
            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">PAINREFORM LTD.</div>
          </td>
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            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
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            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
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            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">By:</div>
          </td>
          <td style="width: 29.64%; vertical-align: top; border-bottom: #000000 2px solid;">
            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">/s/ Ilan Hadar</div>
          </td>
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            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
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            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
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            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
          </td>
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            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Ilan Hadar</div>
          </td>
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            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
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            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
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            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Chief Executive Officer</div>
          </td>
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            <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">&#160;</div>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exhibit_99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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        <hr align="center" style="border: none; border-bottom: 1px solid black; border-top: 4px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;"><font style="font-family: 'Times New Roman',Times,serif;"><u><font style="font-weight: bold;">Exhibit 99.1</font></u></font><br style="line-height: 1.25;">
      </div>
      <div style="text-align: center;"><img src="image00003.jpg"></div>
    </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold;"> <br>
    </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold;">PainReform Provides Year-End Business Update; On track to Commence Phase 3 Trial of </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;"><font style="font-size: 12pt;">PRF-110 for Non-Opiate Post-Operative Pain Relief in the Second Half of 202</font>2</div>
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    </div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;"><font style="font-weight: bold;">Tel Aviv, Israel &#8211; March 17, 2022 &#8211; </font><u>PainReform Ltd.</u> (Nasdaq: PRFX) ("PainReform" or the "Company"), a
      clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today provided a business update for the year ended December 31, 2021.</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">
      <div style="line-height: 1.25;">
        <div style="line-height: 1.25;">Ilan Hadar, Chief Executive Officer, stated, &#8220;We remain on track to commence our Phase 3 clinical trial of PRF-110 in bunionectomy in the second half of 2022.&#160; Specifically, we are advancing the manufacturing of
          PRF-110 clinical batches with our partner Pharmaceutics International, Inc. (PII), a U.S. -based contract manufacturing organization (CMO). After completion of the first trial, we plan to initiate the Phase 3 hernia repair clinical trial based on
          a similar study design to the prior Phase 2 trial. According to <u>Persistance Market Research</u>, the post -operative pain management market was valued at over $35 billion in 2021, of which, opioids accounted for two-thirds of this market.&#160; We
          believe PRF-110 has the potential to address the significant unmet need for a long-acting local anesthetic agent to spare opioid use and reduce hospital length of stay due to complications.&#8221;</div>
        <div style="line-height: 1.25">&#160;</div>
      </div>
    </div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">
      <div style="line-height: 1.25;">
        <div style="line-height: 1.25;">&#8220;At the end of 2021, we had $16.6 million of cash on hand and positive working capital of approximately $18.3 million. We have maintained a healthy balance sheet without any debt. I am excited about the outlook for
          2022 and look forward to a number of key upcoming catalysts that we believe will further enhance shareholder value, including the start of enrolment and dosing of the first patients.&#160; Given that the patient monitoring period is only 72 hours in
          the trial, I expect this to be a rapid and cost-efficient trial,&#8221; concluded Mr. Hadar.</div>
        <div style="line-height: 1.25">&#160;</div>
      </div>
    </div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">Financial Results</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">
      <div style="line-height: 1.25;">
        <div style="line-height: 1.25;">Research and development expenses were $2.9 million for the year ended December 31, 2021, compared to $0.4 million for the year ended December 31, 2020. The increase was primarily due to preparation for the
          initiation of clinical trials.</div>
      </div>
    </div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">
      <div style="line-height: 1.25;">
        <div style="line-height: 1.25;">General and administrative expenses were $4.3 million for the year ended December 31, 2021, compared to $1.3 million for the year ended December 31, 2020. The increase was primarily due to an increase in headcount
          related expenses, as well as an increase in professional services, payroll and related expenses, and insurance related expenses.</div>
      </div>
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    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">
      <div style="line-height: 1.25;">
        <div style="line-height: 1.25;">Financial expense were $32,000 for the year ended December 31, 2021 compared to $2.2 million for the year ended December 31, 2020, a decrease of $2.1 million. The decrease was primarily due to a decrease in the
          change in the fair value of derivative warrant liability, and interest expense and amortization of discount on convertible noteswhich was recognized in 2020.</div>
      </div>
    </div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Net loss for the year ended December 31, 2021 was approximately $7.2 million, compared to a net loss of approximately $4.1 million for the year ended December 31, 2020.&#160;</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; margin-right: 4.5pt; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">As of December 31, 2021, the Company had cash and cash equivalents of $16.6 million.</div>
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    </div>
    <div style="text-align: justify; margin-right: 4.5pt; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">A copy of the Company&#8217;s annual report on Form 20-F for the year ended December 31, 2021 has been filed with the U.S. Securities and
      Exchange Commission at https://www.sec.gov/ and posted on the Company&#8217;s investor relations website at&#160;&#160; https://painreform.com/investors/. The Company will deliver a hard copy of its annual report, including its complete audited consolidated
      financial statements, free of charge, to its shareholders upon request at info@painreform.com.</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">About PainReform</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">PainReform is a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics. PRF-110, the Company's lead
      product, is based on the local anesthetic ropivacaine, targeting the post-operative pain relief market. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed prior to closure to provide localized and
      extended post-operative analgesia. The Company's proprietary extended-release drug-delivery system is designed to provide an extended period of post-surgical pain relief without the need for repeated dose administration while reducing the potential
      need for the use of opiates. For more information, please visit www.painreform.com.</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">Notice Regarding Forward-Looking Statements</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-style: italic;">This press release contains forward looking statements about our expectations, beliefs and intentions. Forward-looking statements can
      be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these
      words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of
      historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or
      revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control.
      Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward- looking statements, including, but not limited to, the following: our history of significant losses, our need to
      raise additional capital and our ability to obtain additional capital on acceptable terms, or at all; our dependence on the success of our initial product candidate, PRF-110; the outcomes of preclinical studies, clinical trials and other research
      regarding PRF-110 and future product candidates;&#160; the impact of the COVID-19 pandemic on our operations; our limited experience managing clinical trials; our ability to retain key personnel and recruit additional employees; our reliance on third
      parties for the conduct of clinical trials, product manufacturing and development; the impact of competition and new technologies; our ability to comply with regulatory requirements relating to the development and marketing of our product candidates;
      commercial success and market acceptance of our product candidates; our ability to establish sales and marketing capabilities or enter into agreements with third parties and our reliance on third party distributors and resellers;&#160; our ability to
      establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for
      intellectual property rights and our ability to operate our business without infringing the intellectual property rights of others; the overall global economic environment; our ability to develop an active trading market for our ordinary shares and
      whether the market price of our ordinary shares is volatile; and statements as to the impact of the political and security situation in Israel on our business. More detailed information about the risks and uncertainties affecting us is contained
      under the heading "Risk Factors" included in the Company's most recent Annual Report on Form 20-F and in other filings that we have made and may make with the Securities and Exchange Commission in the future.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">Contact:</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Crescendo Communications, LLC</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Tel: 212-671-1021</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Email: <u>prfx@crescendo-ir.com</u></div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Ilan Hadar</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Chief Executive Officer</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">PainReform Ltd.</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Tel: +972-54-5331725</div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Email: <u>ihadar@painreform.com</u></div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;"><u> <br>
      </u></div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">
      <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;"><u> </u></div>
  </div>
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