(Note: If there is only one appendix document, Section 17 should be renamed to If “Appendix.” there are multiple documents, it can be left as “Appendices.” Schedule of Events Toxicity Grading Scales Schedule of Events Screening/ 2 Visit 3 Unscheduled/ Enrollment Day 5-9 Day 11-143 Early Evaluation 1 (Test of (Test of Cure Termination Day 1 Cure) Results) Visit5 Signed consent form X Confirmation of eligibility criteria X Medical history for assessment of specific symptoms that are potentially related to fluoroquinolone use as X X X X described in section 9, Assessment of Safety Signs/symptoms X X X Concomitant medications X X X Sexual history X Interim sexual history X X X Targeted physical examination X X X Rapid urine pregnancy test (females) X βhCG Speculum examination (females) X Cervical swab for N. gonorrhoeae culture (females) X2 X2 Cervical or vaginal swab for NAAT and gyrA assay X2 X2 (females)1 Urethral swab for N. gonorrhoeae culture (males) X2 X2
(Note: If there is only one appendix document, Section 17 should be renamed to “Appendix.” If there are multiple documents, it can be left as “Appendices.” Schedule of Events Toxicity Grading Scales Schedule of Events Evaluation Screening/ Enrollment 1 Day 1 2 Day 5-9 (Test of Cure) Visit 3 Day 11-143 (Test of Cure Results) Unscheduled/ Early Termination Visit5 Signed consent form X Confirmation of eligibility criteria X Medical history for assessment of specific symptoms that are potentially related to fluoroquinolone use as described in section 9, Assessment of Safety X X X X Signs/symptoms X X X Concomitant medications X X X Sexual history X Interim sexual history X X X Targeted physical examination X X X Rapid urine βhCG pregnancy test (females) X Speculum examination (females) X Cervical swab for N. gonorrhoeae culture (females) X2 X2 Cervical or vaginal swab for NAAT and gyrA assay (females)1 X2 X2 Urethral swab for N. gonorrhoeae culture (males) X2 X2
DMID%20eCTD%20Compliant%20Interventional%20Protocol%20Template%20and%20Instructions.docx