English — reviewed original text

MEDICINES CONTROL AGENCY MCA THE GAMBIA CLINICAL TRIAL AMENDMENT FORM MCA-F-501/08 MEDICINES CONTROL AGENCY Off Bertil Harding Highway, Kotu East, Kanifing Municipality, P.O. Box 3162, Serekunda, The Gambia, Website: www.mca.gm; E-mail: info@mca.gm; Tel. No.: +2204380632 Date of Current Protocol Protocol Number Amendment version/Date Sponsor Principal Investigator Title of Trial or Acronym MCA CT Number PACTR No Amendment no. Amended Protocol Version/Date Other revisions required Information Sheet ☐ Yes ☐ No ☐ Not applicable Consent form ☐ Yes ☐ No ☐ Not applicable Statistical Analysis Plan ☐ Yes ☐ No ☐ Not applicable Other ☐ Yes ☐ No ☐ Not applicable If yes specify: MCA-F-501/08, Version 3 – 24 January 2025 Page 1 of 2

Clinical Trial Amendment Form MCA The Gambia Amendment Rationale: Proposed Changes SECTION (PAGE) CURRENT PROPOSED CHANGE SUMMARY OF CHANGE JUSTIFICATION Current section and Text currently in use in protocol Text amended Change summarised State specific reason for the page being changed change or refer to rationale Amendment incorporates administrative changes and typo errors along with the substantial changes Name: Role: Signature: Date: MCA-F-501/08, Version 3 – 24 January 2025 Page 2 of 2