The reconstituted solution will be injected intramuscularly across pelvic floor muscles.

For the dilator test, a vaginal dilator was used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. The dilator test was used to assess the change from Baseline in the vaginal dilator induced pain (using the DMTS reported at Baseline). Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥50% decrease from Baseline during the DB treatment period at Week 6 and Week 12.

For the dilator test, a vaginal dilator was used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. The dilator test was used to assess the change from Baseline in the vaginal dilator induced pain (using the DMTS reported at Baseline). Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥30% decrease from Baseline during the DB treatment period at Week 6 and Week 12.

For the dilator test, a vaginal dilator was used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. The dilator test was used to assess the change from Baseline in the vaginal dilator induced pain (using the DMTS reported at Baseline). Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥2-point decrease from Baseline during the DB treatment period at Week 6 and Week 12.

For the dilator test, a set of 8 vaginal dilators of increasing diameter (#1 being the smallest and #8 being the largest) were used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Based on the subjective pain threshold, the largest sized dilator that the participant accepted/tolerated for the test, was defined as the DMTS. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as change from Baseline in the DTMS during the DB treatment period at Week 6 and Week 12.

For the dilator test, a set of 8 vaginal dilators of increasing diameter (#1 being the smallest and #8 being the largest) were used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. The composite score for the vaginal dilator induced pain and dilator size was the sum of all pain measurements across the full range of dilator sizes. For any dilator size that was beyond the DMTS, the pain score was 10. There was to be at least 6 pain scores (recorded by the investigator) to calculate the composite score. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as change from Baseline in the composite score for the dilator test during the DB treatment period at Week 6 and Week 12.

From 2 weeks prior to the next planned visit, all participants rated in the electronic diary (eDiary) once a week the level of the corresponding pain following insertion of the number 6 vaginal dilator into the vagina. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the change from Baseline in participant reported pain score for the number 6 dilator test during the DB treatment period at Week 6 and Week 12.

From 2 weeks prior to the next planned visit, all participants rated in the eDiary once a week the level of the corresponding pain following insertion of the number 6 vaginal dilator into the vagina. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥50% decrease from Baseline in participant reported pain score for the number 6 dilator test during the DB treatment period at Week 6 and Week 12.

From 2 weeks prior to the next planned visit, all participants rated in the eDiary once a week the level of the corresponding pain following insertion of the number 6 vaginal dilator into the vagina. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥30% decrease from Baseline in participants reported pain score for the number 6 dilator test during the DB treatment period at Week 6 and Week 12.

From 2 weeks prior to the next planned visit, all participants rated in the eDiary once a week the level of the corresponding pain following insertion of the number 6 vaginal dilator into the vagina. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a 2-point decrease from Baseline in participant reported pain score for the number 6 dilator test during the DB treatment period at Week 6 and Week 12.

From the Screening visit, and then 2 weeks prior to the next planned visit, participants recorded on a daily basis in the eDiary if they had intercourse and if yes, the level of the corresponding pain during each intercourse instance. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. The 2-week average was used, which was calculated as the average of the score over the last 2 weeks (14 days) prior to the visit. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the change from Baseline in participant reported pain score during intercourse (over the last 2 weeks prior to each visit) during the DB treatment period at Week 6 and Week 12.

From the Screening visit, and then 2 weeks prior to the next planned visit, participants recorded on a daily basis in the eDiary if they had intercourse and if yes, the number of intercourse instances in the previous 24-hour period. The number of intercourse instances over the 2 weeks preceding the visit was calculated as the total recorded number of intercourse instances over 14 days prior to the visit. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the change from Baseline in number of intercourse instances (over the last 2 weeks prior to each visit) during the DB treatment period at Week 6 and Week 12.

From the Screening visit, and then 2 weeks prior to the next planned visit, participants recorded on a daily basis in the eDiary if they had intercourse and also details of any pain rescue medication consumed for each intercourse instance to prevent or treat the vestibular pain. If a participant used the rescue medication associated with at least one instance during the 2-week prior to a visit, the participant was considered as having used the rescue medication for that visit. Results for this outcome are reported as the number of participants using pain rescue medication associated with intercourse (over the last 2 weeks prior to each visit) during the DB treatment period at Baseline, Week 6 and Week 12.

Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 100 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.

Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety).

Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 300 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.

Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety).

Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 400 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.

Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety).

Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 500 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.

Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety).

Total of all reporting groups

Participants may have more than one race.

A set of 8 vaginal dilators of increasing diameter (#1 being the smallest and #8 being the largest) were used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Participants rated the pain for each dilator size on an 11-point Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Based on the subjective pain threshold, the largest sized dilator that the participant accepted/tolerated for the test was defined as the DMTS at the Baseline visit.

A set of 8 vaginal dilators of increasing diameter (#1 being the smallest and #8 being the largest) were used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Participants rated the pain for each dilator size on an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Based on the subjective pain threshold, the largest sized dilator that the participant accepted/tolerated for the test was defined as the DMTS at the Baseline visit.

The study was terminated early prior to starting Stage 2; therefore no analysis was performed for this primary outcome.

For the dilator test, a vaginal dilator was used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. The dilator test was used to assess the change from Baseline in the vaginal dilator induced pain (using the DMTS reported at Baseline). Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as change from Baseline during the DB treatment period at Week 6 and Week 12.

The modified Intent-To-Treat population (mITT) included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.

For the dilator test, a vaginal dilator was used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. The dilator test was used to assess the change from Baseline in the vaginal dilator induced pain (using the DMTS reported at Baseline). Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥50% decrease from Baseline during the DB treatment period at Week 6 and Week 12.

The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.

For the dilator test, a vaginal dilator was used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. The dilator test was used to assess the change from Baseline in the vaginal dilator induced pain (using the DMTS reported at Baseline). Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥30% decrease from Baseline during the DB treatment period at Week 6 and Week 12.

The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.

For the dilator test, a vaginal dilator was used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. The dilator test was used to assess the change from Baseline in the vaginal dilator induced pain (using the DMTS reported at Baseline). Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥2-point decrease from Baseline during the DB treatment period at Week 6 and Week 12.

The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.

For the dilator test, a set of 8 vaginal dilators of increasing diameter (#1 being the smallest and #8 being the largest) were used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Based on the subjective pain threshold, the largest sized dilator that the participant accepted/tolerated for the test, was defined as the DMTS. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as change from Baseline in the DTMS during the DB treatment period at Week 6 and Week 12.

The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.

For the dilator test, a set of 8 vaginal dilators of increasing diameter (#1 being the smallest and #8 being the largest) were used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. The composite score for the vaginal dilator induced pain and dilator size was the sum of all pain measurements across the full range of dilator sizes. For any dilator size that was beyond the DMTS, the pain score was 10. There was to be at least 6 pain scores (recorded by the investigator) to calculate the composite score. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as change from Baseline in the composite score for the dilator test during the DB treatment period at Week 6 and Week 12.

The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.

From 2 weeks prior to the next planned visit, all participants rated in the electronic diary (eDiary) once a week the level of the corresponding pain following insertion of the number 6 vaginal dilator into the vagina. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the change from Baseline in participant reported pain score for the number 6 dilator test during the DB treatment period at Week 6 and Week 12.

The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.

From 2 weeks prior to the next planned visit, all participants rated in the eDiary once a week the level of the corresponding pain following insertion of the number 6 vaginal dilator into the vagina. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥50% decrease from Baseline in participant reported pain score for the number 6 dilator test during the DB treatment period at Week 6 and Week 12.

The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.

From 2 weeks prior to the next planned visit, all participants rated in the eDiary once a week the level of the corresponding pain following insertion of the number 6 vaginal dilator into the vagina. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥30% decrease from Baseline in participants reported pain score for the number 6 dilator test during the DB treatment period at Week 6 and Week 12.

The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.

From 2 weeks prior to the next planned visit, all participants rated in the eDiary once a week the level of the corresponding pain following insertion of the number 6 vaginal dilator into the vagina. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a 2-point decrease from Baseline in participant reported pain score for the number 6 dilator test during the DB treatment period at Week 6 and Week 12.

The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.

From the Screening visit, and then 2 weeks prior to the next planned visit, participants recorded on a daily basis in the eDiary if they had intercourse and if yes, the level of the corresponding pain during each intercourse instance. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. The 2-week average was used, which was calculated as the average of the score over the last 2 weeks (14 days) prior to the visit. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the change from Baseline in participant reported pain score during intercourse (over the last 2 weeks prior to each visit) during the DB treatment period at Week 6 and Week 12.

The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants who had intercourse in the corresponding period, with values at both Baseline and the specified visit were included in the analysis.

From the Screening visit, and then 2 weeks prior to the next planned visit, participants recorded on a daily basis in the eDiary if they had intercourse and if yes, the number of intercourse instances in the previous 24-hour period. The number of intercourse instances over the 2 weeks preceding the visit was calculated as the total recorded number of intercourse instances over 14 days prior to the visit. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the change from Baseline in number of intercourse instances (over the last 2 weeks prior to each visit) during the DB treatment period at Week 6 and Week 12.

The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants who had a partner, with values at both Baseline and the specified visit were included in the analysis.

From the Screening visit, and then 2 weeks prior to the next planned visit, participants recorded on a daily basis in the eDiary if they had intercourse and also details of any pain rescue medication consumed for each intercourse instance to prevent or treat the vestibular pain. If a participant used the rescue medication associated with at least one instance during the 2-week prior to a visit, the participant was considered as having used the rescue medication for that visit. Results for this outcome are reported as the number of participants using pain rescue medication associated with intercourse (over the last 2 weeks prior to each visit) during the DB treatment period at Baseline, Week 6 and Week 12.

The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants who had intercourse in the corresponding period, with values at both Baseline and the specified visit were included in the analysis.

Stage 1:

On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 100 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.

Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety).

Stage 1:

On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 300 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.

Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety).

Stage 1:

On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 400 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.

Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety).

Stage 1:

On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 500 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.

Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety).