Trial Outcomes & Findings for Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis (NCT NCT01016262)

Last Updated: 2019-08-28

Results Overview

Participants were considered as responders if they had total Mayo Disease Activity Index (DAI) score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

119 participants

Primary outcome timeframe

Week 6

Results posted on

2019-08-28

Participant Flow

Out of a total 119 double-blind phase participants, 116 participants (including 9 of the 11 participants that terminated early) further continued in the open-label (OL) phase where, under the amended protocol versions 3 and 4, they were provided the opportunity to voluntarily receive MAX-002, standard care treatment, or no treatment

Participant milestones

Participant milestones
Measure	MAX-002 (Double-blind Phase) MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	Canasa® (Double-blind Phase) Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	Placebo (Double-blind Phase) Matching placebo suppository rectally once daily at bedtime, for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	MAX-002 (Open-label Phase) Participants who completed or discontinued DB phase and provided consent, received MAX-002 suppository 1 g once daily at bedtime for 8 weeks during the OL phase.	Standard Care Treatment (Open-label Phase) Participants who completed or discontinued the DB phase and provided consent, received standard care treatment once daily for 8 weeks as per investigator's judgment during the OL phase.	No Treatment (Open-label Phase) Participants who completed or discontinued the DB phase and provided consent, received no treatment for 8 weeks as per investigator's judgment during OL phase.
Double-blind Phase STARTED	41	39	39	0	0	0
Double-blind Phase COMPLETED	40	38	30	0	0	0
Double-blind Phase NOT COMPLETED	1	1	9	0	0	0
Open-Label Phase STARTED	0	0	0	44	52	20
Open-Label Phase COMPLETED	0	0	0	42	50	20
Open-Label Phase NOT COMPLETED	0	0	0	2	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	MAX-002 (Double-blind Phase) MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	Canasa® (Double-blind Phase) Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	Placebo (Double-blind Phase) Matching placebo suppository rectally once daily at bedtime, for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	MAX-002 (Open-label Phase) Participants who completed or discontinued DB phase and provided consent, received MAX-002 suppository 1 g once daily at bedtime for 8 weeks during the OL phase.	Standard Care Treatment (Open-label Phase) Participants who completed or discontinued the DB phase and provided consent, received standard care treatment once daily for 8 weeks as per investigator's judgment during the OL phase.
Double-blind Phase Adverse Event	0	0	1	0	0
Double-blind Phase Lack of Efficacy	1	0	5	0	0
Double-blind Phase Disease Progression	0	1	2	0	0
Double-blind Phase Withdrawal of Informed Consent	0	0	1	0	0
Open-Label Phase Adverse Event	0	0	0	1	0
Open-Label Phase Lost to Follow-up	0	0	0	0	1
Open-Label Phase Lack of Efficacy	0	0	0	1	0
Open-Label Phase Withdrawal of Informed Consent	0	0	0	0	1

Baseline Characteristics

Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MAX-002 (Double-blind Phase) n=41 Participants MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	Canasa® (Double-blind Phase) n=39 Participants Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	Placebo (Double-blind Phase) n=39 Participants Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase	Total n=119 Participants Total of all reporting groups
Age, Continuous	44.3 years STANDARD_DEVIATION 13.55 • n=5 Participants	44.8 years STANDARD_DEVIATION 11.70 • n=7 Participants	41.8 years STANDARD_DEVIATION 12.84 • n=5 Participants	43.7 years STANDARD_DEVIATION 12.69 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	23 Participants n=5 Participants	61 Participants n=4 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	20 Participants n=7 Participants	16 Participants n=5 Participants	58 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 6

Population: ITT population included all randomized participants. Missing values were imputed using non-responder (NR) imputation method.

Outcome measures

Outcome measures
Measure	Placebo (Double-blind Phase) n=39 Participants Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase	Canasa® (Double-blind Phase) n=39 Participants Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	MAX-002 (Double-blind Phase) n=41 Participants MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
Percentage of Participants Who Were Responders at Week 6	23.1 percentage of participants	46.2 percentage of participants	56.1 percentage of participants

SECONDARY outcome

Timeframe: Week 3

Population: ITT population included all randomized participants. Missing values were imputed using NR imputation method.

Participants considered as responders if they had total Mayo DAI score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).

Outcome measures

Outcome measures
Measure	Placebo (Double-blind Phase) n=39 Participants Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase	Canasa® (Double-blind Phase) n=39 Participants Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	MAX-002 (Double-blind Phase) n=41 Participants MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
Percentage of Participants Who Were Responders at Week 3	12.8 percentage of participants	38.5 percentage of participants	36.6 percentage of participants

SECONDARY outcome

Timeframe: Day 1 up to Week 6

Population: ITT population included all randomized participants.

Time to relief of rectal bleeding was defined as number of days from randomization (Day 1) up to the first date of 3 consecutive days without observation of rectal bleeding during the double-blind phase.

Outcome measures

Outcome measures
Measure	Placebo (Double-blind Phase) n=39 Participants Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase	Canasa® (Double-blind Phase) n=39 Participants Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	MAX-002 (Double-blind Phase) n=41 Participants MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
Time to Relief of Rectal Bleeding	21 days Interval 7.0 to Upper limit of confidence interval was not calculable due to high number of participants who did not experience relief of rectal bleeding prior to completing or withdrawing from the study.	5 days Interval 3.0 to 12.0	6 days Interval 4.0 to 9.0

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: The ITT population included all the participants randomized to study treatment. Missing values were imputed using remaining item average (RIA) imputation algorithm. Here 'n' signifies those participants who were evaluable at specific time point for each arm group, respectively.

The IBDQ is used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 domains of wellness: bowel symptoms (10 questions), systemic symptoms (5 questions), social symptoms (5 questions) and emotional function (12 questions). The response to each question is graded on 7-point likert scale, ranging from 1 (worst aspect) to 7 (best aspect). The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges from 32 to 224 with higher scores indicating a better quality of life.

Outcome measures

Outcome measures
Measure	Placebo (Double-blind Phase) n=39 Participants Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase	Canasa® (Double-blind Phase) n=39 Participants Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	MAX-002 (Double-blind Phase) n=41 Participants MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6 Baseline (n= 41, 39, 39)	149.18 units on a scale Standard Deviation 32.40	153.19 units on a scale Standard Deviation 38.75	153.45 units on a scale Standard Deviation 35.03
Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6 Change at Week 6 (n= 41, 39, 31)	24.48 units on a scale Standard Deviation 27.29	42.42 units on a scale Standard Deviation 31.26	30.59 units on a scale Standard Deviation 28.95

SECONDARY outcome

Timeframe: Day 1 up to Week 6

Population: ITT population included all randomized participants.

Time to relief of tenesmus (feeling of constantly needing to pass stools, even if the bowels are already empty) was defined as the number of days from randomization (Day 1) up to the first date of 3 consecutive days without observation of tenesmus during the double-blind phase.

Outcome measures

Outcome measures
Measure	Placebo (Double-blind Phase) n=39 Participants Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase	Canasa® (Double-blind Phase) n=39 Participants Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	MAX-002 (Double-blind Phase) n=41 Participants MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
Time to Relief of Tenesmus	1 days Interval 1.0 to 10.0	2 days Interval 1.0 to 5.0	3 days Interval 1.0 to 4.0

Adverse Events

MAX-002 (Double-blind Phase)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Canasa® (Double-blind Phase)

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo (Double-blind Phase)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

MAX-002 (Open-label Phase)

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Standard Care Treatment (Open-label Phase)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

No Treatment (Open-label Phase)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MAX-002 (Double-blind Phase) n=40 participants at risk MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	Canasa® (Double-blind Phase) n=41 participants at risk Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	Placebo (Double-blind Phase) n=38 participants at risk Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DL phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	MAX-002 (Open-label Phase) n=44 participants at risk Participants who completed or discontinued the DB phase and provided consent, received MAX-002 suppository 1 g once daily at bedtime for 8 weeks during the OL phase.	Standard Care Treatment (Open-label Phase) n=52 participants at risk Participants who completed or discontinued the DB phase and provided consent, received standard care treatment once daily for 8 weeks as per investigator's judgment during the OL phase.	No Treatment (Open-label Phase) n=20 participants at risk Participants who completed or discontinued the DB phase and provided consent, received no treatment for 8 weeks as per investigator's judgment during OL phase.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
General disorders Non-cardiac chest pain	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.

Other adverse events

Other adverse events
Measure	MAX-002 (Double-blind Phase) n=40 participants at risk MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	Canasa® (Double-blind Phase) n=41 participants at risk Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	Placebo (Double-blind Phase) n=38 participants at risk Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DL phase. Participants then received either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.	MAX-002 (Open-label Phase) n=44 participants at risk Participants who completed or discontinued the DB phase and provided consent, received MAX-002 suppository 1 g once daily at bedtime for 8 weeks during the OL phase.	Standard Care Treatment (Open-label Phase) n=52 participants at risk Participants who completed or discontinued the DB phase and provided consent, received standard care treatment once daily for 8 weeks as per investigator's judgment during the OL phase.	No Treatment (Open-label Phase) n=20 participants at risk Participants who completed or discontinued the DB phase and provided consent, received no treatment for 8 weeks as per investigator's judgment during OL phase.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
General disorders General physical health deterioration	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Metabolism and nutrition disorders Dehydration	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Haematochezia	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Haemorrhoids	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Inguinal hernia	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Proctitis	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
General disorders Fatigue	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	3.8% 2/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
General disorders Asthenia	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
General disorders Chest discomfort	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
General disorders Hernia	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
General disorders Malaise	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
General disorders Pyrexia	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
General disorders Influenza like illness	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.0% 1/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
General disorders Feeling cold	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
General disorders Mucosal inflammation	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Immune system disorders Allergy to animal	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Immune system disorders Seasonal allergy	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Infections and infestations Nasopharyngitis	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	4.9% 2/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	7.9% 3/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	6.8% 3/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.8% 3/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	10.0% 2/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Infections and infestations Influenza	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Infections and infestations Sinusitis	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Infections and infestations Cystitis	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Infections and infestations Cystitis bacterial	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Infections and infestations Eye infection	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Infections and infestations Gastroenteritis	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Infections and infestations Pharyngitis	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	3.8% 2/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.0% 1/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Infections and infestations Tooth infection	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Infections and infestations Urinary tract infection	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Infections and infestations Paronychia	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Infections and infestations Parotitis	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Metabolism and nutrition disorders Anorexia	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Cardiac disorders Palpitations	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Cardiac disorders Myocardial ischaemia	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Ear and labyrinth disorders Vertigo	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Abdominal pain	5.0% 2/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	10.5% 4/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	6.8% 3/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	3.8% 2/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Ear and labyrinth disorders Ear pain	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Nausea	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	10.5% 4/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Anorectal discomfort	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.3% 2/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Vomiting	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Diarrhoea	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Dyspepsia	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Toothache	5.0% 2/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Abdominal distension	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Abdominal rigidity	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Abnormal faeces	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Anal pruritus	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Colitis ulcerative	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Flatulence	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Proctitis ulcerative	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	3.8% 2/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.0% 1/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Umbilical hernia	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Gastrointestinal disorders Colitis	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Blood and lymphatic system disorders Leukopenia	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.0% 1/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Injury, poisoning and procedural complications Spinal cord injury cervical	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Investigations Alanine aminotransferase increased	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Investigations Blood calcium increased	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Investigations Neutrophil count abnormal	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Investigations Neutrophil count decreased	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.0% 1/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Investigations White blood cell count decreased	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.0% 1/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.0% 1/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Musculoskeletal and connective tissue disorders Back pain	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Musculoskeletal and connective tissue disorders Arthralgia	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Musculoskeletal and connective tissue disorders Myalgia	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	3.8% 2/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.0% 1/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Nervous system disorders Dizziness	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Nervous system disorders Headache	7.5% 3/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	14.6% 6/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	15.8% 6/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	6.8% 3/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	3.8% 2/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	15.0% 3/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Nervous system disorders Migraine	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.0% 1/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Nervous system disorders Sinus headache	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Nervous system disorders Somnolence	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Nervous system disorders Hypotonia	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Psychiatric disorders Depression	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Psychiatric disorders Anxiety	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Psychiatric disorders Insomnia	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Psychiatric disorders Fear	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Psychiatric disorders Mood swings	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Psychiatric disorders Nervousness	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Psychiatric disorders Restlessness	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Renal and urinary disorders Bladder pain	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Renal and urinary disorders Micturition urgency	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Renal and urinary disorders Proteinuria	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Reproductive system and breast disorders Vaginal haemorrhage	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.0% 1/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Reproductive system and breast disorders Pelvic pain	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.0% 1/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	4.5% 2/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.4% 1/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Skin and subcutaneous tissue disorders Acne	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Skin and subcutaneous tissue disorders Rash	5.0% 2/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Skin and subcutaneous tissue disorders Pruritus generalised	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.6% 1/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Vascular disorders Lymphangiectasia	2.5% 1/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Vascular disorders Blood pressure fluctuation	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Vascular disorders Hypertension	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Eye disorders Chalazion	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.0% 1/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Eye disorders Conjunctivitis	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	5.0% 1/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Eye disorders Visual acuity reduced	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/40 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/41 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/38 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	2.3% 1/44 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	1.9% 1/52 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.	0.00% 0/20 • Baseline up to end of study (Week 14) Any event that started on or after the first dose of double-blind study medication up to completion of the last study visit (and procedures) at the end of the open-label phase. One participant was randomized to Placebo but received Canasa® and a second participant was randomized to MAX-002 but received Canasa® are reported under the Canasa® treatment group for the Safety population. These patients are reported under their randomized treatment group for the ITT/PP populations.

Additional Information

Robert Winkler, MD, VP, Clinical Development and Operations

Forest Laboratories

Phone: 1-800-472-2634

Results disclosure agreements

Principal investigator is a sponsor employee Restrictions may vary in accordance with each agreement that is negotiated with individual investigators. Sponsor will allow publication after multi-center publication has been published or after an agreed period of time if no such multi-center publication is submitted for publication. Sponsor can ask that Sponsor's confidential information be removed from any publication and defer publication for period of time to allow Sponsor to obtain patent or other intellectual property right protection.
Publication restrictions are in place

Restriction type: OTHER